Colposcopy Versus HPV Testing to Identify Persistent Cervical Precancers (CoHIPP)
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|ClinicalTrials.gov Identifier: NCT01051895|
Recruitment Status : Active, not recruiting
First Posted : January 20, 2010
Last Update Posted : January 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|High Grade Cervical Intra-epithelial Neoplasia||Other: high risk HPV DNA testing Other: Active comparator: Routine colposcopy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2253 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Randomized Controlled Trial Comparing Routine Colposcopy to HPV Testing to Identify Persistent or Recurrent High Grade Cervical Cancer Precursors|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||September 2015|
|Estimated Study Completion Date :||April 2020|
Experimental: HPV testing
Women randomized to this arm will undergo high risk HPV DNA testing using Hybrid Capture 2®.
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 Name: Hybrid Capture 2®
Active Comparator: Routine colposcopy
Women will be followed in the colposcopy clinic as usual, 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.
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.
- Sensitivity of HPV testing and sensitivity of routine colposcopy to identify CIN2 or worse disease after treatment for CIN 2/3 [ Time Frame: 6 months post treatment ]
- The area under the respective ROC curves (HPV testing and routine colposcopy) [ Time Frame: 6 months post treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01051895
|Centre de recherche du CHUM|
|Montreal, Quebec, Canada, H2X 0A9|
|Principal Investigator:||Marie-Hélène Mayrand, MD,PhD||Centre de Recherche du Centre Hospitalier de l'Université de Montréal|