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)
18 Years
N/A
Female
CIN2/3 Recurrence
Trial Information
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.
Inclusion Criteria:
- Women over 18 years
- CIN 2 or 3 diagnosis at inclusion confirmed for a CIN3 diagnosis by conization.
- HPV detected by Hybrid Capture 2 or RLA genotyping.
- Informed and signed consent by the patient and the investigator
- Coverage by French social security
Exclusion Criteria:
- Pregnancy at the time of inclusion.
- Previous history conization.
- Atypical endometrial or glandular cells or evidence of carcinoma on conization.
- Previous vaccination with a prophylactic HPV vaccine.
- Active viral infections including HIV.
- Acquired or congenital immunodeficiency.
- Long term treatment by corticosteroids or immunosuppressive drugs.
- Persons under protection of law.
- Patients unable to meet the requirements of the protocol.
- Any condition that, according to the investigator, would prevent participation in the
study or interfere with the objectives of the study (refusal of supervision at the
University Hospital, expected change of address within 3 years, etc)
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Recurrence of CIN2/3 diagnosed on colposcopy-directed biopsy
Outcome Description:
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
Outcome Time Frame:
For each patient, 24 month after inclusion
Safety Issue:
No
Principal Investigator
Geneviève CHÊNE, MD-PhD
Investigator Role:
Study Chair
Investigator Affiliation:
USMR - University Hospital Bordeaux, France
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
CHUBX 2010/18
NCT ID:
NCT01543048
Start Date:
March 2012
Completion Date:
October 2015
Related Keywords:
- CIN2/3 Recurrence
- Human Papilloma Virus (HPV)
- Virological tests
- CIN3
- Cervical cancer
- Conization
- within women treated by conization for a CIN3
- Neoplasms
- Recurrence
- Cervical Intraepithelial Neoplasia
- Carcinoma in Situ
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