Triage Strategies in Cervical Cancer Prevention

• Conditions: Intraepithelial Neoplasia; Cervical Cancer
• Interventions: Other: HPV screening and triage tests

• Registration Number: NCT02510027
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-08
• Status Verified: 2015-07
• Study First Submitted: 2015-07-24
• Study First Submitted QC: 2015-07-27
• Last Update Submitted: 2015-07-27
• Study First Posted: 2015-07-28
• Last Update Posted: 2015-07-28
• Primary Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women aged 30-64 years old	HPV screening and triage tests	Women aged 30 to 64 years who attend the Cervical Cancer Screening Program in 100 health centers in the state of Tlaxcala, Mexico

Primary Outcome Measures

Name	Time	Method
Histologically confirmed cervical intraepithelial neoplasia grade 2 or worse (CIN2+)	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.

Trial Locations

Locations (1)

Primary health care centers from Sanitary Jurisdiction No. 1 of Tlaxcala Health Services; 🇲🇽 Tlaxcala, Mexico