Overview

This trial is active, not recruiting.

Condition cin2/3 recurrence
Treatment study follow-up
Sponsor University Hospital, Bordeaux
Start date March 2012
End date November 2016
Trial size 106 participants
Trial identifier NCT01543048, CHUBX 2010/18

Summary

CIN2/3 have been increased for many years and mainly concern women aged 25-29 years. They are subsequent to a persistent HPV infection and are classically treated by conization. Recurrences occur in 7 to 18 % of cases, mainly after CIN3 management during the first 2 years of follow-up. Follow-up is crucial to detect and treat recurrence and to select high risk women who might develop cervical cancer. Colposcopy and cytology have been recommended since 1989 by French ANAES, but these methods have poor sensitivity and specificity. However, DNA HPV testing is more sensitive and has demonstrated a very high negative predictive value, while specificity and positive predictive value remain average. Other HPV markers like genotyping, viral load and integration begin to be used in screening but have not been investigated in CIN2/3 follow-up to assess the values of various HPV markers which predict CIN2/3 recurrence after conization. The primary objective is to describe HPV expression (genotyping, viral load, mRNA E6 and E7) at the time of conization and during the follow-up period (6, 12, 24 months) and to assess the prognostic value of HPV 16 expression (viral load, mRNA E6 and E7) to determine the risk of CIN2/3 recurrence after conization, compared to the other clinical and virological risk factors.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
study follow-up
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.

Primary Outcomes

Measure
Recurrence of CIN2/3 diagnosed on colposcopy-directed biopsy
time frame: For each patient, 24 month after inclusion

Secondary Outcomes

Measure
Evaluation of CIN2/3 diagnosis tests
time frame: For each patient, 24 month after inclusion

Eligibility Criteria

Female participants at least 18 years old.

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)

Additional Information

Official title 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)
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University Hospital, Bordeaux.