Clinical trial NCT02510027: Triage Strategies in Cervical Cancer Prevention
Official title: Molecular Triage in Cervical Cancer Prevention: The Tlaxcala Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Cancer
Intraepithelial Neoplasia
Keywords: HPV testing
Triage
Mexico
Cervical cancer screening
Lead sponsor: Instituto Nacional de Salud Publica, Mexico
Sponsor class: OTHER
Collaborators: name: Secretaria de Salud, Mexico
First posted: 2015-07-28
Enrollment: 100000
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Histologically confirmed cervical intraepithelial neoplasia grade 2 or worse (CIN2+)
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tlaxcala
country: Mexico
facility: Primary health care centers from Sanitary Jurisdiction No. 1 of Tlaxcala Health Services
Study officials:
affiliation: Instituto Nacional de Salud Publica, Mexico
name: Eduardo C Lazcano-Ponce, MD DSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.