Intraepithelial NeoplasiaHPVNCT01924117
Genotypification and Predisposing Factors in Human Papilloma Virus Infection
A study testing Linear Array HPV Genotyping assay in people with Intraepithelial Neoplasia, run by Materno-Perinatal Hospital of the State of Mexico.
Trial summary
Objective: Determine the genotypes and risk factors associated with human papilloma virus infection in Mexican women. Methods: It was a cross-sectional study of women attended at the Materno-Perinatal Hospital "Mónica Pretelini" and the Medical Research Center (CICMED), who were asked to complete a risk factor… Read more about this study
- Who is it for?
- Ages 15 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intraepithelial Neoplasia
- What is being tested?
- Linear Array HPV Genotyping assay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Oct 2011
- 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 15 to 60 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Sexually active women 18 to 40 years of age who come to consult the dysplasia clinic.
- Who are not pregnant
- Who have not received pharmacological treatment with antibiotics and / or anti-inflammatory drugs at least one month before the study.
- Who agreed to participate in the study and signed the informed consent letter.
- Acceptance to fill the questionnaire with relevant data related to HPV risk infection
Who cannot join
- Inadequate samples
- Questionnaires with incomplete data
- Women who decided to leave the study
About this study
Official title: Genotypification and Predisposing Factors in Human Papilloma Virus Infection and Its Association With the Carbohydrate Antigen (CA-125) Tumoral Marker
Objective: Determine the genotypes and risk factors associated with human papilloma virus infection in Mexican women.
Methods: It was a cross-sectional study of women attended at the Materno-Perinatal Hospital "Mónica Pretelini" and the Medical Research Center (CICMED), who were asked to complete a risk factor questionnaire and submitted to colposcopy to identify SIL. Cervical swab samples were obtained to perform linear array HPV genotyping test (Roche®, Mannheim, Germany).
Read the detailed description
Principles: The aim of this study was to determine the HPV genotypes in squamous intraepithelial lesions (SIL) in a population sample of the State of Mexico.
Patients:
The inclusion criteria were women submitted to a colposcopy study at the Clinic 221 of the Mexican Social Security Institute (IMSS), Maternal-Perinatal Hospital "Monica Pretelini" (HMPMP), State of Mexico Health Institute (ISEM) and the Medical Research Center (CICMED), Autonomous University of State of México (UAEMex). Women with previous conization were not considered into the study and those whose clinical follow up was lost were excluded.
Sociodemographic factors:
Patients were given a questionnaire to measure the following potential risk factors: age, area of residence, education level, sexual partners, participation in anal sex, age at first intercourse, smoking, use of hormonal contraception, use of condoms, number of pregnancies and vaginal deliveries.
Cervical samples:
Samples were collected by cervical scraping and were preserved in ThinPrep® PreservCyt® Solution (HologicTM Marlborough, Massachusetts, USA).
HPV genotyping:
DNA extraction from the cervical swab samples was performed using the Amplicor kit (Roche®, Mannheim, Germany), isolating simultaneously the β-globin gene along with HPV. HPV positive specimens were subsequently genotyped using the Linear Array HPV Genotyping assay (Roche®, Mannheim, Germany). This test is a qualitative in vitro test for the detection of HPV utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization able to detect 37 anogenital HPV DNA genotypes (6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 45, 51, 52, 53, 54, 55, 56, 58, 59, 61, 62, 64, 66, 67, 68, 69, 70, 71, 72, 73 (MM9), 81, 82 (MM4), 83 (MM7), 84 (MM8), IS39 and CP6108). This technique can detect multiple HPV genotypes in the same sample.
Ethical concerns:
We followed the Declaration of Helsinki and all patients were asked to sign the written informed consent. This study was accepted by the Research and Ethical Committee of the CICMED.
Statistical analysis:
First, descriptive analyzes were performed, secondly, Odds Ratios (OR) and their associated 95% confidence intervals (95% CI) were calculated as well as Chi-square tests and conditional regression model for SIL using the Statistical Package for the Social Sciences (SPSS) 17.0 software. Difference was considered significant at p ≤ 0.05.
- Conditions
- Intraepithelial Neoplasia
- Being tested
- Linear Array HPV Genotyping assay
- Keywords
- cervical intraepithelial neoplasia, HPV, Cancer
- Medical subject headings
- Carcinoma in Situ, Uterine Cervical Dysplasia, Papillomavirus Infections, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linear Array HPV Genotyping assayOther
Also called Linnear Array methodology
All samples with the suspicion of squamous intraepithelial lesion were processed with the Linnear Array methodology to identify HPV genotypes
| Study group | Role | What they receive |
|---|---|---|
| Linear Array HPV Genotyping assay | No intervention | Women submitted to colposcopy with a suspicion of squamous intraepithelial lesion were programmed a clinical follow up to cervical swab in order to extract DNA and perform a Linear Array HPV Genotyping assay (Roche®, Mannheim, Germany). Receives: Other: Linear Array HPV Genotyping assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple HPV infection
While women are revised by colposcopy the Gynecologist will refer them to a cervical swab for DNA extraction in case of suspicious of HPV infection.
Measured: At the moment of the colposcopy
Secondary outcomes (1)
squamous intraepithelial lesions
The pathologist will determine the presence or absence of SIL with the sample taken in the Papanicolaou smear appointment
Measured: Within one week after the cervical sample taken by the technician
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2013 (estimated)
- Study startFeb 2011
- Primary completionMay 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraepithelial NeoplasiaStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Materno-Perinatal Hospital of the State of Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Autonoma del Estado de Mexico
- Responsible party
- Principal investigator, Hugo Mendieta Zeron, Materno-Perinatal Hospital of the State of Mexico
- Investigators
- Hugo Mendieta Zerón, PhD., Study chair, Universidad Autónoma del Estado de MéxicoMaría del Carmen Colín Ferreyra, MSc., Principal investigator, Universidad Autónoma del Estado de México
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01924117
- Sponsor's protocol ID
- 2902/2010UAEMéx
- Acronym
- HPV
- Status last verified
- Aug 2013
- First submitted
- 13 Aug 2013
- Last updated
- 16 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genotypification and Predisposing Factors in Human Papilloma Virus Infection and Its Association With the Carbohydrate Antigen (CA-125) Tumoral Marker
- ClinicalTrials.gov ID
- NCT01924117
- Acronym / sponsor ID
- HPV / 2902/2010UAEMéx
- Conditions
- Intraepithelial Neoplasia
- Keywords
- cervical intraepithelial neoplasia, HPV, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Materno-Perinatal Hospital of the State of MexicoUniversity, hospital or other
- Collaborators
- Universidad Autonoma del Estado de Mexico
- Study start
- Feb 2011
- Primary completion
- May 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 16 Aug 2013 (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.
Objective: Determine the genotypes and risk factors associated with human papilloma virus infection in Mexican women.
Methods: It was a cross-sectional study of women attended at the Materno-Perinatal Hospital "Mónica Pretelini" and the Medical Research Center (CICMED), who were asked to complete a risk factor questionnaire and submitted to colposcopy to identify SIL. Cervical swab samples were obtained to perform linear array HPV genotyping test (Roche®, Mannheim, Germany).
Detailed description
Principles: The aim of this study was to determine the HPV genotypes in squamous intraepithelial lesions (SIL) in a population sample of the State of Mexico.
Patients:
The inclusion criteria were women submitted to a colposcopy study at the Clinic 221 of the Mexican Social Security Institute (IMSS), Maternal-Perinatal Hospital "Monica Pretelini" (HMPMP), State of Mexico Health Institute (ISEM) and the Medical Research Center (CICMED), Autonomous University of State of México (UAEMex). Women with previous conization were not considered into the study and those whose clinical follow up was lost were excluded.
Sociodemographic factors:
Patients were given a questionnaire to measure the following potential risk factors: age, area of residence, education level, sexual partners, participation in anal sex, age at first intercourse, smoking, use of hormonal contraception, use of condoms, number of pregnancies and vaginal deliveries.
Cervical samples:
Samples were collected by cervical scraping and were preserved in ThinPrep® PreservCyt® Solution (HologicTM Marlborough, Massachusetts, USA).
HPV genotyping:
DNA extraction from the cervical swab samples was performed using the Amplicor kit (Roche®, Mannheim, Germany), isolating simultaneously the β-globin gene along with HPV. HPV positive specimens were subsequently genotyped using the Linear Array HPV Genotyping assay (Roche®, Mannheim, Germany). This test is a qualitative in vitro test for the detection of HPV utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization able to detect 37 anogenital HPV DNA genotypes (6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 45, 51, 52, 53, 54, 55, 56, 58, 59, 61, 62, 64, 66, 67, 68, 69, 70, 71, 72, 73 (MM9), 81, 82 (MM4), 83 (MM7), 84 (MM8), IS39 and CP6108). This technique can detect multiple HPV genotypes in the same sample.
Ethical concerns:
We followed the Declaration of Helsinki and all patients were asked to sign the written informed consent. This study was accepted by the Research and Ethical Committee of the CICMED.
Statistical analysis:
First, descriptive analyzes were performed, secondly, Odds Ratios (OR) and their associated 95% confidence intervals (95% CI) were calculated as well as Chi-square tests and conditional regression model for SIL using the Statistical Package for the Social Sciences (SPSS) 17.0 software. Difference was considered significant at p ≤ 0.05.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Linear Array HPV Genotyping assay | No intervention | Other: Linear Array HPV Genotyping assayWomen submitted to colposcopy with a suspicion of squamous intraepithelial lesion were programmed a clinical follow up to cervical swab in order to extract DNA and perform a Linear Array HPV Genotyping assay (Roche®, Mannheim, Germany). |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Sexually active women 18 to 40 years of age who come to consult the dysplasia clinic.
- Who are not pregnant
- Who have not received pharmacological treatment with antibiotics and / or anti-inflammatory drugs at least one month before the study.
- Who agreed to participate in the study and signed the informed consent letter.
- Acceptance to fill the questionnaire with relevant data related to HPV risk infection
Key exclusion criteria (3 listed)
- Inadequate samples
- Questionnaires with incomplete data
- Women who decided to leave the 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 |
|---|---|---|
| Linear Array HPV Genotyping assayAlso: Linnear Array methodologyAll samples with the suspicion of squamous intraepithelial lesion were processed with the Linnear Array methodology to identify HPV genotypes | Other | Linear Array HPV Genotyping assay |
Primary outcome
Multiple HPV infection
Time frame: At the moment of the colposcopy
While women are revised by colposcopy the Gynecologist will refer them to a cervical swab for DNA extraction in case of suspicious of HPV infection.
1 secondary outcome
squamous intraepithelial lesions
Time frame: Within one week after the cervical sample taken by the technician
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2013.
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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.
Hugo Mendieta Zerón, PhD. study chair
Universidad Autónoma del Estado de México
María del Carmen Colín Ferreyra, MSc. principal investigator
Universidad Autónoma del Estado de México
Questions about this trial
What is this clinical trial studying?
A study testing Linear Array HPV Genotyping assay in people with Intraepithelial Neoplasia, run by Materno-Perinatal Hospital of the State of 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 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: finished, as of the sponsor's last update on 16 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Multiple HPV infection (time frame: At the moment of the colposcopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2013.