NCT02510027

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100,000

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Last Updated

July 28, 2015

Status Verified

July 1, 2015

Enrollment Period

4.3 years

First QC Date

July 24, 2015

Last Update Submit

July 27, 2015

Conditions

Cervical CancerIntraepithelial Neoplasia

Keywords

HPV testingTriageMexicoCervical cancer screening

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Other: HPV screening and triage tests

Interventions

HPV screening and triage testsOTHER

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.

Women aged 30-64 years old

Eligibility Criteria

Age30 Years - 64 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This is a population-based study that includes all women aged 30 to 64 years living in the 32 municipalities in Tlaxcala covered by Sanitary Jurisdiction No. 1 of Tlaxcala Health Services

You may qualify if:

  • Women aged 30 to 64
  • Residents of the municipalities included in Sanitary Jurisdiction No. 1 of Tlaxcala.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary health care centers from Sanitary Jurisdiction No. 1 of Tlaxcala Health Services

Tlaxcala City, Tlaxcala, Mexico

RECRUITING

Related Publications (3)

  • Torres-Ibarra L, Lorincz AT, Wheeler CM, Cuzick J, Hernandez-Lopez R, Spiegelman D, Leon-Maldonado L, Rivera-Paredez B, Mendez-Hernandez P, Lazcano-Ponce E, Salmeron J. Adjunctive testing by cytology, p16/Ki-67 dual-stained cytology or HPV16/18 E6 oncoprotein for the management of HPV16/18 screen-positive women. Int J Cancer. 2021 May 1;148(9):2264-2273. doi: 10.1002/ijc.33414. Epub 2020 Dec 22.

    PMID: 33252834DERIVED

  • Hernandez-Lopez R, Lorincz AT, Torres-Ibarra L, Reuter C, Scibior-Bentkowska D, Warman R, Nedjai B, Mendiola-Pastrana I, Leon-Maldonado L, Rivera-Paredez B, Ramirez-Palacios P, Lazcano-Ponce E, Cuzick J, Salmeron J; FRIDA Study Group. Methylation estimates the risk of precancer in HPV-infected women with discrepant results between cytology and HPV16/18 genotyping. Clin Epigenetics. 2019 Oct 12;11(1):140. doi: 10.1186/s13148-019-0743-9.

    PMID: 31606044DERIVED

  • Rudolph SE, Lorincz A, Wheeler CM, Gravitt P, Lazcano-Ponce E, Torres-Ibarra L, Leon-Maldonado L, Ramirez P, Rivera B, Hernandez R, Franco EL, Cuzick J, Mendez-Hernandez P, Salmeron J; FRIDA Study Group. Population-based prevalence of cervical infection with human papillomavirus genotypes 16 and 18 and other high risk types in Tlaxcala, Mexico. BMC Infect Dis. 2016 Sep 1;16(1):461. doi: 10.1186/s12879-016-1782-x.

    PMID: 27585544DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Two cervical samples will be collected using a Cervex-Brush® (Rovers®). The first collected sample will be placed in a vial containing BD CytoRich™ preservative (BD Diagnostics, Burlington, NC), and the second sample will be placed in a ThinPrep® vial (Hologic, Inc., Bedford, MA). Both samples will be temporarily stored at room temperature at the health center until they are delivered to the lab facilities. Women who refuse a pelvic examination will be offered the option to self-collect a vaginal sample at the health facility or at their home that can be used for hrHPV testing. Only HR-HPV positive participants will move onto the cytology/molecular triage testing phase. After triage procedures, all remaining samples collected in either of the vials from HR-HPV positive women will be stored independently for additional analysis as required by the study procedures.

MeSH Terms

Conditions

Uterine Cervical NeoplasmsCarcinoma in Situ

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Eduardo C Lazcano-Ponce, MD DSc

    Instituto Nacional de Salud Publica, Mexico

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge Salmerón, MD DSc

CONTACT

+52-7771002364jorge.salmec@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Eduardo Lazcano-Ponce, MD, DSc

Study Record Dates

First Submitted

July 24, 2015

First Posted

July 28, 2015

Study Start

August 1, 2013

Primary Completion

December 1, 2017

Last Updated

July 28, 2015

Record last verified: 2015-07

Locations

ME(1)