Triage Strategies in Cervical Cancer Prevention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cervical Cancer Intraepithelial Neoplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

HPV screening and triage tests

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes