Cervical CancerFRIDANCT02510027
Triage Strategies in Cervical Cancer Prevention
An observational study of Cervical Cancer and Intraepithelial Neoplasia, run by Instituto Nacional de Salud Publica, Mexico at 1 site in Mexico.
Trial summary
While there is broad consensus that HR-HPV detection is the best available primary screening test, there is no agreement about the most efficient and reliable triage procedure for HR-HPV positive women. Read more about this study
- Who is it for?
- Ages 30 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Intraepithelial Neoplasia
- What is being tested?
- HPV screening and triage tests
- How many people
- 100,000 participants
- Where
- 1 siteMexico
- Study dates
- Aug 2013to Dec 2017
- Phase
- Observational
- 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 30 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: This is a population-based study that includes all women aged 30 to 64 years living in the 32 municipalities in Tlaxcala covered by Sanitary Jurisdiction No. 1 of Tlaxcala Health Services
Who may be able to join
- Women aged 30 to 64
- Residents of the municipalities included in Sanitary Jurisdiction No. 1 of Tlaxcala.
Who cannot join
- Pregnant or hysterectomized women
- Legally disabled women unable to give verbal informed consent required by the study protocol
- Women who do not wish to participate in the present study
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Primary health care centers from Sanitary Jurisdiction No. 1 of Tlaxcala Health Services
Tlaxcala City, Tlaxcala
Jorge Salmerón, DSc, +52-246-4645879, jorge.salmec@gmail.com
About this study
Official title: Molecular Triage in Cervical Cancer Prevention: The Tlaxcala Study
While there is broad consensus that HR-HPV detection is the best available primary screening test, there is no agreement about the most efficient and reliable triage procedure for HR-HPV positive women. Transient HR-HPV infections are very common, and the vast majority of these infections spontaneously regress after a year or two. Only a small fraction of cases will lead to persistent infection responsible for cervical neoplasia. The FRIDA Study is a large, population-based study that was designed to evaluate the performance and cost-effectiveness of different triage strategies for hrHPV-positive women in Mexico.
Read the detailed description
The target population is over <100,000 women aged 30 to 64 years who attend the Cervical Cancer Screening Program in 100 health centers in the state of Tlaxcala, Mexico. All women will be evaluated to determine hrHPV infection using the Cobas® 4800 HPV test. Triage strategies will be performed as reflex tests in all hrHPV-positive participants: HPV-16/18/45 genotyping, detection of the E6 oncoprotein of HPV-16/18, cytology, and immunocytochemistry using p16INK4a/Ki67. Women with at least one positive triage test will be referred for colposcopy evaluation, where a minimum of four biopsies and an endocervical sample are systematically collected. Histological confirmation will be performed by a standardized panel of pathologists.
- Conditions
- Cervical Cancer, Intraepithelial Neoplasia
- Being tested
- HPV screening and triage tests
- Keywords
- HPV testing, Triage, Mexico, Cervical cancer screening
- Medical subject headings
- Uterine Cervical Neoplasms, Carcinoma in Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV screening and triage testsOther
All cervical and/or vaginal specimens are tested for hrHPV using the Cobas® 4800 HPV test. Triage testing will be performed on all participants with a positive HR-HPV test declared consent at recruitment visit: HPV16/18 genotyping, Cobas® 4800 HPV test, HPV16/18/45 genotyping, BD OnclarityTM HPV Assay, OncoE6 Cervical Test, Liquid based cytology with Papanicolaou stain and p16INK4a/ Ki-67 immunostain.
| Study group | Role | What they receive |
|---|---|---|
| Women aged 30-64 years old | Women aged 30 to 64 years who attend the Cervical Cancer Screening Program in 100 health centers in the state of Tlaxcala, Mexico Receives: Other: HPV screening and triage tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histologically confirmed cervical intraepithelial neoplasia grade 2 or worse (CIN2+)
All women will be colposcopically evaluated in order to rule out any clinically evident invasive cancer. In cases of invasive cancer, patients will be referred to onco-gynecology services immediately. Before biopsy collection, endocervical sampling is performed using an Endocervex Brush®. A minimum of four biopsies are collected, at least one per quadrant, from the more suspicious area on cervical transformation zone. Histological evaluation of all samples (biopsies and/or endocervical curettage samples) will be evaluated for final diagnosis and confirmation of CIN2+ cases by two pathologists according to Mexico's Cervical Cancer Screening Programme's guidelines. An external expert-pathologist, will resolve discrepancies and render a final decision.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2015 (estimated)
- Study startAug 2013
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Salud Publica, Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Secretaria de Salud, Mexico
- Responsible party
- Principal investigator, Eduardo Cesar Lazcano Ponce, Instituto Nacional de Salud Publica, Mexico
- Investigators
- Eduardo C Lazcano-Ponce, MD DSc, Principal investigator, Instituto Nacional de Salud Publica, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510027
- Sponsor's protocol ID
- 1094
- Acronym
- FRIDA
- Status last verified
- Jul 2015
- First submitted
- 24 Jul 2015
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Torres-Ibarra L, Lorincz AT, Wheeler CM, Cuzick J, Hernandez-Lopez R, Spiegelman D, Leon-Maldonado L, Rivera-Paredez B, Mendez-Hernandez P, Lazcano-Ponce E, Salmeron J. Adjunctive testing by cytology, p16/Ki-67 dual-stained cytology or HPV16/18 E6 oncoprotein for the management of HPV16/18 screen-positive women. Int J Cancer. 2021 May 1;148(9):2264-2273. doi: 10.1002/ijc.33414. Epub 2020 Dec 22.
PubMed 33252834Hernandez-Lopez R, Lorincz AT, Torres-Ibarra L, Reuter C, Scibior-Bentkowska D, Warman R, Nedjai B, Mendiola-Pastrana I, Leon-Maldonado L, Rivera-Paredez B, Ramirez-Palacios P, Lazcano-Ponce E, Cuzick J, Salmeron J; FRIDA Study Group. Methylation estimates the risk of precancer in HPV-infected women with discrepant results between cytology and HPV16/18 genotyping. Clin Epigenetics. 2019 Oct 12;11(1):140. doi: 10.1186/s13148-019-0743-9.
PubMed 31606044Rudolph SE, Lorincz A, Wheeler CM, Gravitt P, Lazcano-Ponce E, Torres-Ibarra L, Leon-Maldonado L, Ramirez P, Rivera B, Hernandez R, Franco EL, Cuzick J, Mendez-Hernandez P, Salmeron J; FRIDA Study Group. Population-based prevalence of cervical infection with human papillomavirus genotypes 16 and 18 and other high risk types in Tlaxcala, Mexico. BMC Infect Dis. 2016 Sep 1;16(1):461. doi: 10.1186/s12879-016-1782-x.
PubMed 27585544
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Triage in Cervical Cancer Prevention: The Tlaxcala Study
- ClinicalTrials.gov ID
- NCT02510027
- Acronym / sponsor ID
- FRIDA / 1094
- Conditions
- Cervical Cancer, Intraepithelial Neoplasia
- Keywords
- HPV testing, Triage, Mexico, Cervical cancer screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Instituto Nacional de Salud Publica, MexicoUniversity, hospital or other
- Collaborators
- Secretaria de Salud, Mexico
- Study start
- Aug 2013
- Primary completion
- Dec 2017 (estimated)
- First posted
- 28 Jul 2015 (estimated)
- 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.
While there is broad consensus that HR-HPV detection is the best available primary screening test, there is no agreement about the most efficient and reliable triage procedure for HR-HPV positive women. Transient HR-HPV infections are very common, and the vast majority of these infections spontaneously regress after a year or two. Only a small fraction of cases will lead to persistent infection responsible for cervical neoplasia. The FRIDA Study is a large, population-based study that was designed to evaluate the performance and cost-effectiveness of different triage strategies for hrHPV-positive women in Mexico.
Detailed description
The target population is over <100,000 women aged 30 to 64 years who attend the Cervical Cancer Screening Program in 100 health centers in the state of Tlaxcala, Mexico. All women will be evaluated to determine hrHPV infection using the Cobas® 4800 HPV test. Triage strategies will be performed as reflex tests in all hrHPV-positive participants: HPV-16/18/45 genotyping, detection of the E6 oncoprotein of HPV-16/18, cytology, and immunocytochemistry using p16INK4a/Ki67. Women with at least one positive triage test will be referred for colposcopy evaluation, where a minimum of four biopsies and an endocervical sample are systematically collected. Histological confirmation will be performed by a standardized panel of pathologists.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women aged 30-64 years old | – | Other: HPV screening and triage testsWomen aged 30 to 64 years who attend the Cervical Cancer Screening Program in 100 health centers in the state of Tlaxcala, Mexico |
Who may qualify
- Ages
- 30 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This is a population-based study that includes all women aged 30 to 64 years living in the 32 municipalities in Tlaxcala covered by Sanitary Jurisdiction No. 1 of Tlaxcala Health Services
Key inclusion criteria (2 listed)
- Women aged 30 to 64
- Residents of the municipalities included in Sanitary Jurisdiction No. 1 of Tlaxcala.
Key exclusion criteria (3 listed)
- Pregnant or hysterectomized women
- Legally disabled women unable to give verbal informed consent required by the study protocol
- Women who do not wish to participate in the present study
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 |
|---|---|---|
| HPV screening and triage testsAll cervical and/or vaginal specimens are tested for hrHPV using the Cobas® 4800 HPV test. Triage testing will be performed on all participants with a positive HR-HPV test declared consent at recruitment visit: HPV16/18 genotyping, Cobas® 4800 HPV test, HPV16/18/45 genotyping, BD OnclarityTM HPV Assay, OncoE6 Cervical Test, Liquid based cytology with Papanicolaou stain and p16INK4a/ Ki-67 immunostain. | Other | Women aged 30-64 years old |
Primary outcome
Histologically confirmed cervical intraepithelial neoplasia grade 2 or worse (CIN2+)
Time frame: 36 months
All women will be colposcopically evaluated in order to rule out any clinically evident invasive cancer. In cases of invasive cancer, patients will be referred to onco-gynecology services immediately. Before biopsy collection, endocervical sampling is performed using an Endocervex Brush®. A minimum of four biopsies are collected, at least one per quadrant, from the more suspicious area on cervical transformation zone. Histological evaluation of all samples (biopsies and/or endocervical curettage samples) will be evaluated for final diagnosis and confirmation of CIN2+ cases by two pathologists according to Mexico's Cervical Cancer Screening Programme's guidelines. An external expert-pathologist, will resolve discrepancies and render a final decision.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
- Derived from this study: PubMed 33252834Torres-Ibarra L, Lorincz AT, Wheeler CM, Cuzick J, Hernandez-Lopez R, Spiegelman D, Leon-Maldonado L, Rivera-Paredez B, Mendez-Hernandez P, Lazcano-Ponce E, Salmeron J. Adjunctive testing by cytology, p16/Ki-67 dual-stained cytology or HPV16/18 E6 oncoprotein for the management of HPV16/18 screen-positive women. Int J Cancer. 2021 May 1;148(9):2264-2273. doi: 10.1002/ijc.33414. Epub 2020 Dec 22.
- Derived from this study: PubMed 31606044Hernandez-Lopez R, Lorincz AT, Torres-Ibarra L, Reuter C, Scibior-Bentkowska D, Warman R, Nedjai B, Mendiola-Pastrana I, Leon-Maldonado L, Rivera-Paredez B, Ramirez-Palacios P, Lazcano-Ponce E, Cuzick J, Salmeron J; FRIDA Study Group. Methylation estimates the risk of precancer in HPV-infected women with discrepant results between cytology and HPV16/18 genotyping. Clin Epigenetics. 2019 Oct 12;11(1):140. doi: 10.1186/s13148-019-0743-9.
- Derived from this study: PubMed 27585544Rudolph SE, Lorincz A, Wheeler CM, Gravitt P, Lazcano-Ponce E, Torres-Ibarra L, Leon-Maldonado L, Ramirez P, Rivera B, Hernandez R, Franco EL, Cuzick J, Mendez-Hernandez P, Salmeron J; FRIDA Study Group. Population-based prevalence of cervical infection with human papillomavirus genotypes 16 and 18 and other high risk types in Tlaxcala, Mexico. BMC Infect Dis. 2016 Sep 1;16(1):461. doi: 10.1186/s12879-016-1782-x.
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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.
Eduardo C Lazcano-Ponce, MD DSc principal investigator
Instituto Nacional de Salud Publica, Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer and Intraepithelial Neoplasia, run by Instituto Nacional de Salud Publica, Mexico 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Jul 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorge Salmerón, MD DSc (+52-7771002364, jorge.salmec@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histologically confirmed cervical intraepithelial neoplasia grade 2 or worse (CIN2+) (time frame: 36 months). 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 NCT02510027, which also lists 3 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 28 Jul 2015.