Atypical Squamous Cell of Undetermined SignificanceNCT07211204
Comparison Of Cytology And Molecular Screening For Detecting Cervical Reactive Cellular Changes In General Population
A study testing Physical examination, Liquid-based cytology and Molecular screening in people with Atypical Squamous Cell of Undetermined Significance and ASC-US, run by Timser SAPI de CV at 1 site in Mexico.
Trial summary
This study compares the efficacy of cytology (Pap smear) with the molecular screening in their ability to detect reactive cellular changes in the cervix among an open population Read more about this study
- Who is it for?
- Ages 18 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Atypical Squamous Cell of Undetermined Significance, ASC-US, Atypical Glandular Cells of Uncertain Significance
- What is being tested?
- Physical examination, Liquid-based cytology and Molecular screening
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- 27 Feb 2026to 27 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be in good general health.
- Age 18-85 years.
- A minimum fast of 6 hours and no more than 12 hours.
- Refrain from sexual intercourse 24 hours before the study.
- Give written informed consent.
Who cannot join
- Having a subtotal, total, or radical hysterectomy.
- Being pregnant or suspected of being pregnant. A rapid urine test will be performed. If the result is positive, the patient will be excluded from the protocol and referred for prenatal care.
- Being under oncological treatment (chemotherapy, radiotherapy and/or brachytherapy).
- Being on their period.
- Have a previous confirmatory diagnosis of HIV and/or hepatitis infection.
- Having taken antiplatelet medications, e.g., acetylsalicylic acid, at least 24 hours before the study.
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- Discontinuation Criteria:
- If the participant refuses any of the study procedures.
- If the study gynecologist detects that the participant has had a hysterectomy.
- If the volume of the biological samples is insufficient (less than 10 mL for the blood sample).
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Clinica Reina Madre Metepec
San Mateo Atenco, State of Mexico, 52105
About this study
Official title: Study To Compare The Efficacy Of Cervical Cytology With Molecular Screening In The Detection Of Reactive Cellular Changes In The Cervix In An Open Population
This study compares the efficacy of cytology (Pap smear) with the molecular screening in their ability to detect reactive cellular changes in the cervix among an open population
Read the detailed description
The primary goal of this study is to compare the efficacy of the cytology (Pap smear) with the molecular screening -of three human biomarkers- in their ability to detect reactive cellular changes in the cervix among an open population. Participants will be asked to attend two study visits. All the clinical procedures will be done on the first visit:
- Explanation of the study and its procedures. Only participants that give their written Informed Consent will be enrolled in the study.
- Interview and physical examination to obtain a medical record. The interview will collect information related to known risks factors for cervical lesions.
- Venipuncture to obtain a blood sample.
- Colposcopy to obtain a cervical smear and a colposcopic diagnosis. The cervical smear will be used to perform liquid-based cytology and HPV detection.
- Biopsy, only if the gynecologist detects a cervical lesion or another abnormality during colposcopy.
The gynecologist will make preliminary recommendations based on the colposcopic findings.
During the second visit the study's gynecologist will explain the tests' results and provide clinical recommendations to each participant.
The sensitivity, specificity, and predictive values of cytology, HPV detection, and molecular screening will be calculated using colposcopy (for all participants) and histopathology (for those biopsied). These results will be compared using a DeLong test. Correlation tests will be performed using risk factors data and test results.
- Conditions
- Atypical Squamous Cell of Undetermined Significance, ASC-US, Atypical Glandular Cells of Uncertain Significance, AGUS, Cervical Intraepithelial Neoplasia (CIN), CIN 1
- Being tested
- Physical examination, Liquid-based cytology, Molecular screening, HPV DNA test, Colposcopy
- Keywords
- Cervical precursor lesions, Reactive cellular changes, Cervical cancer
- Medical subject headings
- Atypical Squamous Cells of the Cervix, Uterine Cervical Dysplasia, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical examinationProcedure or surgery
Also called Clinical examination
Physical examination and interview for obtaining a medical record
Liquid-based cytologyOther
Also called LBC
Screening test for cervical precursor lesions and/or cancer. LBC is a procedure in which a cervical smear is examined under the microscope.
Molecular screeningOther
Also called Circulating biomarker screening
The molecular screening detects three human biomarkers associated with cervical precursor lesions and/or cervical cancer. Biomarker detection is done by Western blot and ELISA in human sera.
HPV DNA testOther
Also called HPV PCR test, HPV screening, HPV detection, Human papillomavirus DNA test
HPV DNA detection is performed using a cervical swab.
ColposcopyDiagnostic test
A diagnostic procedure to visually examine the cervix, vagina, and vulva with a colposcope.
HistopathologyDiagnostic test
Also called Cervical biopsy, Biopsy, Histopathologic examination, Histopathologic analysis
Is the definitive diagnosis of cervical precursor lesions and cervical cancer. It is the microscopic study of diseased cells and tissues stained with hematoxylin and eosin.
| Study group | Role | What they receive |
|---|---|---|
| Screening for reactive cellular changes in the cervix | Other | Participants will be drawn from an open population, so they will be asymptomatic for any cervical disease. Based on colposcopy, there will be four clinical groups: negative control (CTR), low-grade squamous intraepithelial lesion (LSIL, CIN-1), high-grade squamous intraepithelial lesion (HSIL, CIN-2/3), and cervical cancer (CC). Receives: Procedure: Physical examination; Other: Liquid-based cytology; Other: Molecular screening; Other: HPV DNA test; Diagnostic Test: Colposcopy |
| Histopathology of cervical biopsy | Other | Based on colposcopy, participants in the groups LSIL/CIN-1, HSIL/CIN-2/3, and cervical cancer (CC) will be biopsied. Receives: Diagnostic Test: Histopathology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liquid-based Cytology LBC results (categorical)
Study of cells -of the cervix- using a microscope. Cytology is the official screening test for cervical precursor lesions and/or cervical cancer in most countries.
Cytology's results:
Negative to lesion/malignancy. Negative with inflammation. Negative with sexually transmitted infection. Negative with HPV/Herpes cytopathic changes. Negative with atrophy. Positive with ASC-US. Positive with ASC-H. Positive with AGUS. Positive with CIN-1. Positive with CIN-2. Positive with CIN-3. Positive with carcinoma in situ. Positive with LSIL/HSIL. Positive with adenocarcinoma. Positive with Cancer/Malignancy. Positive with probable lesion/cancer/malignancy.
Measured: Cervical smear will be taken during the first visit (Day 1). LBC results will be available within a maximum of 20 days after sampling. This test will be performed by a Licensed Clinical laboratory. All participants will be subjected to this test.
Molecular screening results (dichotomic)
Molecular screening detects three human protein biomarkers in human sera by Western blot and ELISA. Western blot results are qualitative (band intensity units or IU) and ELISA results are quantitative (ng/mL). The final result for molecular screening test is computed as follows:
Negative. Only if the three independent biomarkers are below their cutoff values.
Positive. If any of the three independent biomarkers is equal to or greater than its cutoff value.
Cutoff values are as follows:
Biomarker 1 positive >= 1.37 IU. Biomarker 1 negative < 1.37 IU. Biomarker 2 positive >= 17.74 ng/mL. Biomarker 2 negative < 17.74 ng/mL. Biomarker 3 positive >= 0.38 IU. Biomarker 3 negative < 0.38 IU.
Measured: Blood samples will be taken during the first visit (Day 1). Molecular screening results will be available within a maximum of 20 days after sampling. All participants will be subjected to this test.
HPV test results (categorical)
HPV test will detect fifteen different high-risk genotypes by PCR:
HPV-16 genotype. HPV-18 genotype. HPV-pool (including HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 67, and 68 genotypes).
The final test result will be assigned as follows:
Positive HPV test: If at least one of the fifteen genotypes is detected. Negative HPV test: Only if none of the fifteen genotypes are detected.
Measured: Cervical smear will be taken during the first visit (Day 1). HPV test results will be available within a maximum of 20 days after sampling. This test will be performed by a Licensed Clinical laboratory. All participants will be subjected to this test.
Colposcopy diagnosis (categorical)
Colposcopy is the exploration of the female genitalia -vulva, vagina, and cervix- using a lighted magnifying instrument (colposcope). Its accuracy is higher than that of the cytology. If the gynecologist detects/suspects a lesion or malignancy during colposcopy, a biopsy will be drawn for histopathologic analysis.
Colposcopy results:
Negative with no alterations. Negative with inflammation. Negative with condyloma/condylomatosis/HPV. Negative with atrophy. Negative with squamous metaplasia. Negative with ectropion/ectopy/cervical erosion/cervical eversion/glandular eversion.
Negative with Nabothian cysts. Negative with cervical polyp. Negative with Lichen sclerosus. Positive with CIN-1. Positive with CIN-2. Positive with CIN-3. Positive with carcinoma in situ CIN-3. Positive with neoplasia/invasive neoplasia. Positive with LSIL/HSIL. Positive with probable lesion/CIN/LSIL/HSIL.
Measured: Colposcopy will be performed during the first visit (Day 1). This diagnostic test will be performed by a licensed gynecologist. All participants will be subjected to this diagnostic test. Colposcopy will be used as a reference test.
Histopathology diagnosis (cathegorical)
Histopathology is the microscopic analysis of a stained slide of a cervical biopsy by a licensed pathologist. The standard staining is H\&E (hematoxylin and eosin).
Histopathology results:
Negative with normal tissue. Negative with cervicitis. Negative with HPV/Herpes infection. Positive with CIN-1. Positive with CIN-2. Positive with CIN-3. Positive with carcinoma in situ CIN-3. Positive LSIL/HSIL. Positive with microinvasive/invasive cancer. Positive with adenocarcinoma. Positive with sarcoma and other tumors. Positive with carcinoma of unknown primary origin/unspecified malignancy.
Measured: The biopsy for histopathology will be drawn during the first visit (Day 1). Biopsies will be drawn only from women with positive colposcopy results. Histopathology is the gold standard for cervical cancer diagnosis.
Secondary outcomes (14)
Body Mass Index (BMI)
The study physician will record the participants:
Weight in kilograms (kg). Height in meters (m). The Body Mass Index will be calculated as follows: BMI = kg/m^2.
Measured: During the first visit (Day 1).
Blood pressure
Blood pressure is the amount of force the blood uses to get through the circulatory system measured in mmHg. It consists of two measurements:
Systolic pressure in mmHg, e.g., 120 mmHg. Diastolic pressure in mmHg, e.g., 80 mmHg. The final result will display the two independent measurements, e.g., 120/80 mmHg.
Measured: During the first visit (Day 1).
Ethnicity
Ethnicity data will be obtained through clinical interview. Ethnicity is linked to cultural expression and identity.
Ethnicity options:
Hispanic/Latino. Not Hispanic/Latino.
Measured: During the first visit (Day 1) by clinical interview.
Race
Race data will be obtained through clinical interview. Race is linked to physical characteristics.
Race options:
American Indian. Alaska Native. Asian. Black or African American. African Mexican. Native Hawaiian or Other Pacific Islander. Mexican Original People. White.
Measured: During the first visit (Day 1) by clinical interview.
Age at Menarche
Age at menarche -in years- will be obtained during the clinical interview. Menarche is the first menstrual period in a female adolescent, typically occurs between the ages of 10 and 16.
Measured: During the first visit (Day 1) by clinical interview.
Age at sexual debut
The age at sexual debut -in years- will be obtained during the clinical interview. The age will be recorded in years.
Measured: During the first visit (Day 1) by clinical interview.
Number of years since menarche to sexual debut
The number of years since menarche to sexual debut will be calculated as follows:
NYSMSD = Age of Sexual Debut - Age of Menarche
Measured: During the first visit (Day 1) by clinical interview.
Number of lifetime sexual partners
The number of lifetime sexual partners of the participants will be obtained during the clinical interview.
Measured: During the first visit (Day 1) by clinical interview.
Number of years since last cytology
The year of last or previous cytology will be obtained during the clinical interview. The number of years since las cytology will be calculated as follows:
NYSLCy =Year of Participation in the Study - Year of Last/Previous Cytology.
Measured: During the first visit (Day 1) by clinical interview.
Number of years since colposcopy
The year of last or previous colposcopy will be obtained during the clinical interview. The number of years since last colposcopy will be calculated as follows:
NYSLCo =Year of Participation in the Study - Year of Last/Previous Colposcopy.
Measured: During the first visit (Day 1) by clinical interview.
Number of abortions
The number of abortions will be obtained during the clinical interview.
Measured: During the first visit (Day 1) by clinical interview.
Number of vaginal deliveries
The number of vaginal deliveries will be obtained during the clinical interview
Measured: During the first visit (Day 1) by clinical interview.
Number of Caesarean sections
The number of Caesarean sections will be obtained during the clinical interview.
Measured: During the first visit (Day 1) by clinical interview.
Number of cigarettes per week
The number of cigarettes per week will be obtained during the clinical interview.
Measured: During the first visit (Day 1) by clinical interview.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start27 Feb 2026
- Primary completion27 Feb 2026
- Study completion27 Feb 2026
Why it stopped: The study did not start, i.e., no participants were enrolled, because the Mexican Regulatory Authority (COFEPRIS) did not authorize the amendments to the protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Atypical Squamous Cell of Undetermined SignificanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Group 1. All participants will receive a colposcopy, Pap smear, and a venipuncture. Diagnosis by colposcopy will set four clinical groups: negative control (CTR), low-grade squamous intraepithelial lesions LSIL (CIN-1), high-grade squamous intraepithelial lesions HSIL (CIN-2/3), and cervical cancer (CC). Group 2. The participants in groups LSIL, HSIL, and CC will be biopsied. The histopathology analysis of the biopsy is the gold standard for the diagnosis.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Timser SAPI de CV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leopoldo E Gatica-Galina, MD in OB/GY & Gynecol Oncol, Principal investigator, Clinica Reina Madre Metepec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211204
- Sponsor's protocol ID
- PROT-ATSO-INV-003
- Other IDs
- 2024-EXT-886
- Status last verified
- Feb 2026
- First submitted
- 3 Jun 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All de-identified individual participant data will be publicly available in the supplementary material associated with the scientific publication.
Publications
Serdar CC, Cihan M, Yucel D, Serdar MA. Sample size, power and effect size revisited: simplified and practical approaches in pre-clinical, clinical and laboratory studies. Biochem Med (Zagreb). 2021 Feb 15;31(1):010502. doi: 10.11613/BM.2021.010502. Epub 2020 Dec 15.
PubMed 33380887Rozemeijer K, Penning C, Siebers AG, Naber SK, Matthijsse SM, van Ballegooijen M, van Kemenade FJ, de Kok IM. Comparing SurePath, ThinPrep, and conventional cytology as primary test method: SurePath is associated with increased CIN II+ detection rates. Cancer Causes Control. 2016 Jan;27(1):15-25. doi: 10.1007/s10552-015-0678-1. Epub 2015 Oct 12.
PubMed 26458884Bell ML, Kenward MG, Fairclough DL, Horton NJ. Differential dropout and bias in randomised controlled trials: when it matters and when it may not. BMJ. 2013 Jan 21;346:e8668. doi: 10.1136/bmj.e8668.
PubMed 23338004Hajian-Tilaki K. Sample size estimation in diagnostic test studies of biomedical informatics. J Biomed Inform. 2014 Apr;48:193-204. doi: 10.1016/j.jbi.2014.02.013. Epub 2014 Feb 26.
PubMed 24582925DeLong ER, DeLong DM, Clarke-Pearson DL. Comparing the areas under two or more correlated receiver operating characteristic curves: a nonparametric approach. Biometrics. 1988 Sep;44(3):837-45.
PubMed 3203132Hu ZY, Xiao L, Bode AM, Dong Z, Cao Y. Glycolytic genes in cancer cells are more than glucose metabolic regulators. J Mol Med (Berl). 2014 Aug;92(8):837-45. doi: 10.1007/s00109-014-1174-x. Epub 2014 Jun 8.
PubMed 24906457Xue C, Gu X, Li G, Bao Z, Li L. Expression and Functional Roles of Eukaryotic Initiation Factor 4A Family Proteins in Human Cancers. Front Cell Dev Biol. 2021 Nov 19;9:711965. doi: 10.3389/fcell.2021.711965. eCollection 2021.
PubMed 34869305Li H, Liu J, Shen S, Dai D, Cheng S, Dong X, Sun L, Guo X. Pan-cancer analysis of alternative splicing regulator heterogeneous nuclear ribonucleoproteins (hnRNPs) family and their prognostic potential. J Cell Mol Med. 2020 Oct;24(19):11111-11119. doi: 10.1111/jcmm.15558. Epub 2020 Sep 11.
PubMed 32915499Dreyfuss G, Matunis MJ, Pinol-Roma S, Burd CG. hnRNP proteins and the biogenesis of mRNA. Annu Rev Biochem. 1993;62:289-321. doi: 10.1146/annurev.bi.62.070193.001445. No abstract available.
PubMed 8352591Checa-Rojas A, Delgadillo-Silva LF, Velasco-Herrera MDC, Andrade-Dominguez A, Gil J, Santillan O, Lozano L, Toledo-Leyva A, Ramirez-Torres A, Talamas-Rohana P, Encarnacion-Guevara S. GSTM3 and GSTP1: novel players driving tumor progression in cervical cancer. Oncotarget. 2018 Apr 24;9(31):21696-21714. doi: 10.18632/oncotarget.24796. eCollection 2018 Apr 24.
PubMed 29774096William W, Ware A, Basaza-Ejiri AH, Obungoloch J. A pap-smear analysis tool (PAT) for detection of cervical cancer from pap-smear images. Biomed Eng Online. 2019 Feb 12;18(1):16. doi: 10.1186/s12938-019-0634-5.
PubMed 30755214Shin MB, Garcia PJ, Saldarriaga EM, Fiestas JL, Asbjornsdottir KH, Iribarren SJ, Barnabas RV, Gimbel S. Cost of community-based human papillomavirus self-sampling in Peru: A micro-costing study. Lancet Reg Health Am. 2022 Apr;8:100160. doi: 10.1016/j.lana.2021.100160. Epub 2021 Dec 29.
PubMed 35528707Giannella L, Di Giuseppe J, Delli Carpini G, Grelloni C, Fichera M, Sartini G, Caimmi S, Natalini L, Ciavattini A. HPV-Negative Adenocarcinomas of the Uterine Cervix: From Molecular Characterization to Clinical Implications. Int J Mol Sci. 2022 Nov 30;23(23):15022. doi: 10.3390/ijms232315022.
PubMed 36499345Jenkins D, Molijn A, Kazem S, Pirog EC, Alemany L, de Sanjose S, Dinjens W, Quint W. Molecular and pathological basis of HPV-negative cervical adenocarcinoma seen in a global study. Int J Cancer. 2020 Nov 1;147(9):2526-2536. doi: 10.1002/ijc.33124. Epub 2020 Jul 6.
PubMed 32474915Lee JE, Chung Y, Rhee S, Kim TH. Untold story of human cervical cancers: HPV-negative cervical cancer. BMB Rep. 2022 Sep;55(9):429-438. doi: 10.5483/BMBRep.2022.55.9.042.
PubMed 35725012
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study To Compare The Efficacy Of Cervical Cytology With Molecular Screening In The Detection Of Reactive Cellular Changes In The Cervix In An Open Population
- ClinicalTrials.gov ID
- NCT07211204
- Acronym / sponsor ID
- PROT-ATSO-INV-003
- Conditions
- Atypical Squamous Cell of Undetermined Significance, ASC-US, Atypical Glandular Cells of Uncertain Significance, AGUS, Cervical Intraepithelial Neoplasia (CIN), CIN 1
- Keywords
- Cervical precursor lesions, Reactive cellular changes, Cervical cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study did not start, i.e., no participants were enrolled, because the Mexican Regulatory Authority (COFEPRIS) did not authorize the amendments to the protocol.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Timser SAPI de CVIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2026 (actual)
- Primary completion
- 27 Feb 2026 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares the efficacy of cytology (Pap smear) with the molecular screening in their ability to detect reactive cellular changes in the cervix among an open population
Detailed description
The primary goal of this study is to compare the efficacy of the cytology (Pap smear) with the molecular screening -of three human biomarkers- in their ability to detect reactive cellular changes in the cervix among an open population. Participants will be asked to attend two study visits. All the clinical procedures will be done on the first visit:
- Explanation of the study and its procedures. Only participants that give their written Informed Consent will be enrolled in the study.
- Interview and physical examination to obtain a medical record. The interview will collect information related to known risks factors for cervical lesions.
- Venipuncture to obtain a blood sample.
- Colposcopy to obtain a cervical smear and a colposcopic diagnosis. The cervical smear will be used to perform liquid-based cytology and HPV detection.
- Biopsy, only if the gynecologist detects a cervical lesion or another abnormality during colposcopy.
The gynecologist will make preliminary recommendations based on the colposcopic findings.
During the second visit the study's gynecologist will explain the tests' results and provide clinical recommendations to each participant.
The sensitivity, specificity, and predictive values of cytology, HPV detection, and molecular screening will be calculated using colposcopy (for all participants) and histopathology (for those biopsied). These results will be compared using a DeLong test. Correlation tests will be performed using risk factors data and test results.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Group 1. All participants will receive a colposcopy, Pap smear, and a venipuncture. Diagnosis by colposcopy will set four clinical groups: negative control (CTR), low-grade squamous intraepithelial lesions LSIL (CIN-1), high-grade squamous intraepithelial lesions HSIL (CIN-2/3), and cervical cancer (CC). Group 2. The participants in groups LSIL, HSIL, and CC will be biopsied. The histopathology analysis of the biopsy is the gold standard for the diagnosis.
| Arm | Type | Receives |
|---|---|---|
| Screening for reactive cellular changes in the cervix | Other | Procedure: Physical examination, Other: Liquid-based cytology, Other: Molecular screening, Other: HPV DNA test, Diagnostic Test: ColposcopyParticipants will be drawn from an open population, so they will be asymptomatic for any cervical disease. Based on colposcopy, there will be four clinical groups: negative control (CTR), low-grade squamous intraepithelial lesion (LSIL, CIN-1), high-grade squamous intraepithelial lesion (HSIL, CIN-2/3), and cervical cancer (CC). |
| Histopathology of cervical biopsy | Other | Diagnostic Test: HistopathologyBased on colposcopy, participants in the groups LSIL/CIN-1, HSIL/CIN-2/3, and cervical cancer (CC) will be biopsied. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be in good general health.
- Age 18-85 years.
- A minimum fast of 6 hours and no more than 12 hours.
- Refrain from sexual intercourse 24 hours before the study.
- Give written informed consent.
Key exclusion criteria (10 listed)
- Having a subtotal, total, or radical hysterectomy.
- Being pregnant or suspected of being pregnant. A rapid urine test will be performed. If the result is positive, the patient will be excluded from the protocol and referred for prenatal care.
- Being under oncological treatment (chemotherapy, radiotherapy and/or brachytherapy).
- Being on their period.
- Have a previous confirmatory diagnosis of HIV and/or hepatitis infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical examinationAlso: Clinical examinationPhysical examination and interview for obtaining a medical record | Procedure or surgery | Screening for reactive cellular changes in the cervix |
| Liquid-based cytologyAlso: LBCScreening test for cervical precursor lesions and/or cancer. LBC is a procedure in which a cervical smear is examined under the microscope. | Other | Screening for reactive cellular changes in the cervix |
| Molecular screeningAlso: Circulating biomarker screeningThe molecular screening detects three human biomarkers associated with cervical precursor lesions and/or cervical cancer. Biomarker detection is done by Western blot and ELISA in human sera. | Other | Screening for reactive cellular changes in the cervix |
| HPV DNA testAlso: HPV PCR test, HPV screening, HPV detection, Human papillomavirus DNA testHPV DNA detection is performed using a cervical swab. | Other | Screening for reactive cellular changes in the cervix |
| ColposcopyA diagnostic procedure to visually examine the cervix, vagina, and vulva with a colposcope. | Diagnostic test | Screening for reactive cellular changes in the cervix |
| HistopathologyAlso: Cervical biopsy, Biopsy, Histopathologic examination, Histopathologic analysisIs the definitive diagnosis of cervical precursor lesions and cervical cancer. It is the microscopic study of diseased cells and tissues stained with hematoxylin and eosin. | Diagnostic test | Histopathology of cervical biopsy |
Primary outcome
Liquid-based Cytology LBC results (categorical)
Time frame: Cervical smear will be taken during the first visit (Day 1). LBC results will be available within a maximum of 20 days after sampling. This test will be performed by a Licensed Clinical laboratory. All participants will be subjected to this test.
Study of cells -of the cervix- using a microscope. Cytology is the official screening test for cervical precursor lesions and/or cervical cancer in most countries. Cytology's results: Negative to lesion/malignancy. Negative with inflammation. Negative with sexually transmitted infection. Negative with HPV/Herpes cytopathic changes. Negative with atrophy. Positive with ASC-US. Positive with ASC-H. Positive with AGUS. Positive with CIN-1. Positive with CIN-2. Positive with CIN-3. Positive with carcinoma in situ. Positive with LSIL/HSIL. Positive with adenocarcinoma. Positive with Cancer/Malignancy. Positive with probable lesion/cancer/malignancy.
Molecular screening results (dichotomic)
Time frame: Blood samples will be taken during the first visit (Day 1). Molecular screening results will be available within a maximum of 20 days after sampling. All participants will be subjected to this test.
Molecular screening detects three human protein biomarkers in human sera by Western blot and ELISA. Western blot results are qualitative (band intensity units or IU) and ELISA results are quantitative (ng/mL). The final result for molecular screening test is computed as follows: Negative. Only if the three independent biomarkers are below their cutoff values. Positive. If any of the three independent biomarkers is equal to or greater than its cutoff value. Cutoff values are as follows: Biomarker 1 positive >= 1.37 IU. Biomarker 1 negative < 1.37 IU. Biomarker 2 positive >= 17.74 ng/mL. Biomarker 2 negative < 17.74 ng/mL. Biomarker 3 positive >= 0.38 IU. Biomarker 3 negative < 0.38 IU.
HPV test results (categorical)
Time frame: Cervical smear will be taken during the first visit (Day 1). HPV test results will be available within a maximum of 20 days after sampling. This test will be performed by a Licensed Clinical laboratory. All participants will be subjected to this test.
HPV test will detect fifteen different high-risk genotypes by PCR: HPV-16 genotype. HPV-18 genotype. HPV-pool (including HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 67, and 68 genotypes). The final test result will be assigned as follows: Positive HPV test: If at least one of the fifteen genotypes is detected. Negative HPV test: Only if none of the fifteen genotypes are detected.
Colposcopy diagnosis (categorical)
Time frame: Colposcopy will be performed during the first visit (Day 1). This diagnostic test will be performed by a licensed gynecologist. All participants will be subjected to this diagnostic test. Colposcopy will be used as a reference test.
Colposcopy is the exploration of the female genitalia -vulva, vagina, and cervix- using a lighted magnifying instrument (colposcope). Its accuracy is higher than that of the cytology. If the gynecologist detects/suspects a lesion or malignancy during colposcopy, a biopsy will be drawn for histopathologic analysis. Colposcopy results: Negative with no alterations. Negative with inflammation. Negative with condyloma/condylomatosis/HPV. Negative with atrophy. Negative with squamous metaplasia. Negative with ectropion/ectopy/cervical erosion/cervical eversion/glandular eversion. Negative with Nabothian cysts. Negative with cervical polyp. Negative with Lichen sclerosus. Positive with CIN-1. Positive with CIN-2. Positive with CIN-3. Positive with carcinoma in situ CIN-3. Positive with neoplasia/invasive neoplasia. Positive with LSIL/HSIL. Positive with probable lesion/CIN/LSIL/HSIL.
Histopathology diagnosis (cathegorical)
Time frame: The biopsy for histopathology will be drawn during the first visit (Day 1). Biopsies will be drawn only from women with positive colposcopy results. Histopathology is the gold standard for cervical cancer diagnosis.
Histopathology is the microscopic analysis of a stained slide of a cervical biopsy by a licensed pathologist. The standard staining is H\&E (hematoxylin and eosin). Histopathology results: Negative with normal tissue. Negative with cervicitis. Negative with HPV/Herpes infection. Positive with CIN-1. Positive with CIN-2. Positive with CIN-3. Positive with carcinoma in situ CIN-3. Positive LSIL/HSIL. Positive with microinvasive/invasive cancer. Positive with adenocarcinoma. Positive with sarcoma and other tumors. Positive with carcinoma of unknown primary origin/unspecified malignancy.
14 secondary outcomes
Body Mass Index (BMI)
Time frame: During the first visit (Day 1).
Blood pressure
Time frame: During the first visit (Day 1).
Ethnicity
Time frame: During the first visit (Day 1) by clinical interview.
Race
Time frame: During the first visit (Day 1) by clinical interview.
Age at Menarche
Time frame: During the first visit (Day 1) by clinical interview.
Age at sexual debut
Time frame: During the first visit (Day 1) by clinical interview.
Number of years since menarche to sexual debut
Time frame: During the first visit (Day 1) by clinical interview.
Number of lifetime sexual partners
Time frame: During the first visit (Day 1) by clinical interview.
Number of years since last cytology
Time frame: During the first visit (Day 1) by clinical interview.
Number of years since colposcopy
Time frame: During the first visit (Day 1) by clinical interview.
Number of abortions
Time frame: During the first visit (Day 1) by clinical interview.
Number of vaginal deliveries
Time frame: During the first visit (Day 1) by clinical interview.
Number of Caesarean sections
Time frame: During the first visit (Day 1) by clinical interview.
Number of cigarettes per week
Time frame: During the first visit (Day 1) by clinical interview.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
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- Background: PubMed 26458884Rozemeijer K, Penning C, Siebers AG, Naber SK, Matthijsse SM, van Ballegooijen M, van Kemenade FJ, de Kok IM. Comparing SurePath, ThinPrep, and conventional cytology as primary test method: SurePath is associated with increased CIN II+ detection rates. Cancer Causes Control. 2016 Jan;27(1):15-25. doi: 10.1007/s10552-015-0678-1. Epub 2015 Oct 12.
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- Background: PubMed 24582925Hajian-Tilaki K. Sample size estimation in diagnostic test studies of biomedical informatics. J Biomed Inform. 2014 Apr;48:193-204. doi: 10.1016/j.jbi.2014.02.013. Epub 2014 Feb 26.
- Background: PubMed 3203132DeLong ER, DeLong DM, Clarke-Pearson DL. Comparing the areas under two or more correlated receiver operating characteristic curves: a nonparametric approach. Biometrics. 1988 Sep;44(3):837-45.
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- Background: PubMed 34869305Xue C, Gu X, Li G, Bao Z, Li L. Expression and Functional Roles of Eukaryotic Initiation Factor 4A Family Proteins in Human Cancers. Front Cell Dev Biol. 2021 Nov 19;9:711965. doi: 10.3389/fcell.2021.711965. eCollection 2021.
- Background: PubMed 32915499Li H, Liu J, Shen S, Dai D, Cheng S, Dong X, Sun L, Guo X. Pan-cancer analysis of alternative splicing regulator heterogeneous nuclear ribonucleoproteins (hnRNPs) family and their prognostic potential. J Cell Mol Med. 2020 Oct;24(19):11111-11119. doi: 10.1111/jcmm.15558. Epub 2020 Sep 11.
- Background: PubMed 8352591Dreyfuss G, Matunis MJ, Pinol-Roma S, Burd CG. hnRNP proteins and the biogenesis of mRNA. Annu Rev Biochem. 1993;62:289-321. doi: 10.1146/annurev.bi.62.070193.001445. No abstract available.
- Background: PubMed 29774096Checa-Rojas A, Delgadillo-Silva LF, Velasco-Herrera MDC, Andrade-Dominguez A, Gil J, Santillan O, Lozano L, Toledo-Leyva A, Ramirez-Torres A, Talamas-Rohana P, Encarnacion-Guevara S. GSTM3 and GSTP1: novel players driving tumor progression in cervical cancer. Oncotarget. 2018 Apr 24;9(31):21696-21714. doi: 10.18632/oncotarget.24796. eCollection 2018 Apr 24.
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- World Health Organization \& International Agency for Research on Cancer. Global Cancer ObservatoryLink provided by the sponsor.
- World Health Organization. Global Strategy to Accelerate the Elimination of Cervical Cancer as a Public Health ProblemLink provided by the sponsor.
- Sellors JW \& Sankaranarayanan R. An introduction to Cervical Intraepithelial Neoplasia (CIN). in Colposcopy and treatment of cervical intraepithelial neoplasia: a beginners manualLink provided by the sponsor.
- International Agency for Research on Cancer. CanScreen5. Cervical Cancer Screening Programme. Country Fact Sheet: MexicoLink provided by the sponsor.
- Mexico's Ministry of Health. NOM-014-SSA2-1994. For Prevention, Detection, Diagnosis, Treatment, Control and Epidemiological Surveillance of Cervical CancerLink provided by the sponsor.
- World Health Organization. WHO Guideline for Screening and Treatment of Cervical Pre-Cancer Lesions for Cervical Cancer Prevention.Link provided by the sponsor.
- Individual participant dataSharing planned: No. All de-identified individual participant data will be publicly available in the supplementary material associated with the scientific publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leopoldo E Gatica-Galina, MD in OB/GY & Gynecol Oncol principal investigator
Clinica Reina Madre Metepec
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical examination, Liquid-based cytology and Molecular screening in people with Atypical Squamous Cell of Undetermined Significance and ASC-US, run by Timser SAPI de CV at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liquid-based Cytology LBC results (categorical) (time frame: Cervical smear will be taken during the first visit (Day 1). LBC results will be available within a maximum of 20 days after sampling. This test will be performed by a Licensed Clinical laboratory. All participants will be subjected to this test.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07211204, which also lists 37 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.