Prognostic Value of Human Papillomavirus (HPV) Detection in Cervical Intra-epithelial Neoplasia (CIN) Recurrence After Conization: Prospective Study With Virological Follow-up on 24 Months (SUIVICOL)
Women with CIN3 treated by conization will be consecutively included in this study during 12
months. They will be recruited in the 3 main University Hospitals of South West France
(Bordeaux, Toulouse, Limoges) and followed-up for 24 months. Colposcopy (+/- biopsies),
cytology, and virology tests will be performed at the time of conization and during the
follow-up period (6, 12, 24 months). HPV expression will be assessed by centralized
validated marketed tests (Hybrid Capture 2, RLA genotyping, PreTect® HPV-Proofer) and by a
real time PCR measuring E2, E6 and E7 viral load of HPV 1.
Observational
Observational Model: Cohort, Time Perspective: Prospective
Recurrence of CIN2/3 diagnosed on colposcopy-directed biopsy
Biopsies will be carried out in cases of abnormal findings by colposcopy, cytological anomalies (ASC-US, ASC-H, LSIL, HSIL, cancer), and/or colpo-cytological discordance. The prognostic impact of HPV16 compared to the other HR-HPV on the recurrence of CIN2/3 will be assessed
For each patient, 24 month after inclusion
No
Geneviève CHÊNE, MD-PhD
Study Chair
USMR - University Hospital Bordeaux, France
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
CHUBX 2010/18
NCT01543048
March 2012
October 2015
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