Colposcopy Versus HPV Testing to Identify Persistent Cervical Precancers

NAActive, not recruitingINTERVENTIONAL
Enrollment

2,253

Participants

Timeline

Start Date

January 31, 2010

Primary Completion Date

September 30, 2015

Study Completion Date

June 30, 2025

Conditions
High Grade Cervical Intra-epithelial Neoplasia
Interventions
OTHER

high risk HPV DNA testing

Specimens will be collected with a cervical cytobrush and cervical cells will be resuspended in 2 ml of Preservcyt® (Hologic LP), a liquid cytology preservation media. 75µl of processed sample will be hybridized with 25 µl of probe B mixture. The assay is completed as a standard enzyme immunoassay with the addition of a dioxetane-based chemiluminescent substrate. Specimens will be considered positive for HPV if the ratio of RLUs of the specimen to the mean RLUs of triplicates of positive control (at 1 pg per ml or 5000 copies of HPV genome per test) is at least one.

OTHER

Active comparator: Routine colposcopy

Women will undergo colposcopy, with no standardized protocol; tests are left at the discretion of the treating physician, in order to document routine proactive. We will document all procedures (biopsies, endocervical curettage, cytology, etc) and their outcome.

Trial Locations (1)

H2X 0A9

Centre de recherche du CHUM, Montreal

All Listed Sponsors
collaborator

Terry Fox Foundation

OTHER

collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

lead

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER