MedTrace Logo

Triage Strategies in Cervical Cancer Prevention

NCT02510027 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100000

Last updated 2015-07-28

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Secretaria de Salud, Mexico

    collaborator OTHER_GOV

  • Instituto Nacional de Salud Publica, Mexico

    lead OTHER

Principal Investigators

  • Eduardo C Lazcano-Ponce, MD DSc · Instituto Nacional de Salud Publica, Mexico

Eligibility

Min Age
30 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2017-12-31

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02510027 on ClinicalTrials.gov