Triage Strategies in Cervical Cancer Prevention (FRIDA)
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|ClinicalTrials.gov Identifier: NCT02510027|
Recruitment Status : Unknown
Verified July 2015 by Eduardo Cesar Lazcano Ponce, Instituto Nacional de Salud Publica, Mexico.
Recruitment status was: Recruiting
First Posted : July 28, 2015
Last Update Posted : July 28, 2015
|Condition or disease||Intervention/treatment|
|Cervical Cancer Intraepithelial Neoplasia||Other: HPV screening and triage tests|
|Study Type :||Observational|
|Estimated Enrollment :||100000 participants|
|Official Title:||Molecular Triage in Cervical Cancer Prevention: The Tlaxcala Study|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||December 2017|
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
Other: HPV screening and triage tests
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.
- 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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02510027
|Contact: Jorge Salmerón, MD DScemail@example.com|
|Primary health care centers from Sanitary Jurisdiction No. 1 of Tlaxcala Health Services||Recruiting|
|Contact: Jorge Salmerón, DSc +52-246-4645879 firstname.lastname@example.org|
|Principal Investigator:||Eduardo C Lazcano-Ponce, MD DSc||Instituto Nacional de Salud Publica, Mexico|