Triage Strategies in Cervical Cancer Prevention (FRIDA)

Secretariat of Health

Status: Unknown

Conditions: Intraepithelial Neoplasia; Cervical Cancer

Treatments: Other: HPV screening and triage tests

Study type: Observational

Funder types: Other

Identifiers

NCT02510027

1094

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100,000 estimated patients

Sex: Female

Ages: 30 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100,000 participants in 1 patient group

Women aged 30-64 years old

Description:

Women aged 30 to 64 years who attend the Cervical Cancer Screening Program in 100 health centers in the state of Tlaxcala, Mexico

Treatment:

Other: HPV screening and triage tests