Triage Strategies in Cervical Cancer Prevention

Cervical Cancer Clinical Trial

— FRIDA  

Official title:

Molecular Triage in Cervical Cancer Prevention: The Tlaxcala Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02510027
• Other study ID #: 1094
• Status: Recruiting
• Phase: N/A
• First received: July 24, 2015
• Last updated: July 27, 2015
• Start date: August 2013

Study information

• Verified date: July 2015
• Source: Instituto Nacional de Salud Publica, Mexico
• Contact: Jorge Salmerón, MD DSc
• Phone: +52-7771002364
• Email: jorge.salmec[@]gmail.com
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Sanitary Risks Protection
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100000
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 64 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Cancer
• Intraepithelial Neoplasia
• Uterine Cervical Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Mexico	Primary health care centers from Sanitary Jurisdiction No. 1 of Tlaxcala Health Services	Tlaxcala

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Nacional de Salud Publica, Mexico	Secretaria de Salud, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	36 months	No