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Trial record 18 of 3065 for:    Mexico | Mexico

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
Sponsor:
Collaborator:
Secretaria de Salud, Mexico
Information provided by (Responsible Party):
Eduardo Cesar Lazcano Ponce, Instituto Nacional de Salud Publica, Mexico

Brief 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. 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.

Condition or disease Intervention/treatment
Cervical Cancer Intraepithelial Neoplasia Other: HPV screening and triage tests

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 Type : Observational
Estimated Enrollment : 100000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular Triage in Cervical Cancer Prevention: The Tlaxcala Study
Study Start Date : August 2013
Estimated Primary Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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
Two cervical samples will be collected using a Cervex-Brush® (Rovers®). The first collected sample will be placed in a vial containing BD CytoRich™ preservative (BD Diagnostics, Burlington, NC), and the second sample will be placed in a ThinPrep® vial (Hologic, Inc., Bedford, MA). Both samples will be temporarily stored at room temperature at the health center until they are delivered to the lab facilities. Women who refuse a pelvic examination will be offered the option to self-collect a vaginal sample at the health facility or at their home that can be used for hrHPV testing. Only HR-HPV positive participants will move onto the cytology/molecular triage testing phase. After triage procedures, all remaining samples collected in either of the vials from HR-HPV positive women will be stored independently for additional analysis as required by the study procedures.


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Ages Eligible for Study:   30 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  • Women aged 30 to 64
  • Residents of the municipalities included in Sanitary Jurisdiction No. 1 of Tlaxcala.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
Contact: Jorge Salmerón, MD DSc +52-7771002364 jorge.salmec@gmail.com

Locations
Mexico
Primary health care centers from Sanitary Jurisdiction No. 1 of Tlaxcala Health Services Recruiting
Tlaxcala, Mexico
Contact: Jorge Salmerón, DSc    +52-246-4645879    jorge.salmec@gmail.com   
Sponsors and Collaborators
Instituto Nacional de Salud Publica, Mexico
Secretaria de Salud, Mexico
Investigators
Principal Investigator: Eduardo C Lazcano-Ponce, MD DSc Instituto Nacional de Salud Publica, Mexico

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eduardo Cesar Lazcano Ponce, Eduardo Lazcano-Ponce, MD, DSc, Instituto Nacional de Salud Publica, Mexico
ClinicalTrials.gov Identifier: NCT02510027     History of Changes
Other Study ID Numbers: 1094
First Posted: July 28, 2015    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: July 2015

Keywords provided by Eduardo Cesar Lazcano Ponce, Instituto Nacional de Salud Publica, Mexico:
HPV testing
Triage
Mexico
Cervical cancer screening

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Carcinoma in Situ
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type