Prognostic Value of Human Papillomavirus (HPV) Detection in Cervical Intra-epithelial Neoplasia (CIN) Recurrence After Conization (SUIVICOL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01543048
First received: February 27, 2012
Last updated: May 7, 2014
Last verified: May 2014

February 27, 2012
May 7, 2014
March 2012
May 2016   (final data collection date for primary outcome measure)
Recurrence of CIN2/3 diagnosed on colposcopy-directed biopsy [ Time Frame: For each patient, 24 month after inclusion ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01543048 on ClinicalTrials.gov Archive Site
Evaluation of CIN2/3 diagnosis tests [ Time Frame: For each patient, 24 month after inclusion ] [ Designated as safety issue: No ]

Sensitivity, specificity, positive and negative predictive values of the following tests in the diagnosis of CIN2/3 after conization:

  • Cytology (at the ASC-US threshold)
  • Colposcopy (at the grade 2 abnormal transformation threshold)
  • Hybrid Capture 2 (positivity threshold: 2 pg/ml)
  • RLA genotyping (presence or not of HPV 16 and/or other HR-HPV)
  • PreTect® HPV-Proofer (presence or not of mRNA E6 and E7 of HPV 16, 18, 31, 33, 45)
Same as current
Not Provided
Not Provided
 
Prognostic Value of Human Papillomavirus (HPV) Detection in Cervical Intra-epithelial Neoplasia (CIN) Recurrence After Conization
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)

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.

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
Not Provided
Retention:   Samples With DNA
Description:

Cervical samples

Non-Probability Sample

Women with CIN3 treated by conization

CIN2/3 Recurrence
Other: 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.
Women with CIN3 treated by conization
Intervention: Other: Study Follow-Up
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
May 2016
May 2016   (final data collection date for primary outcome measure)

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)
Female
18 Years and older
No
Contact: Jean-Luc BRUN, MD (0)556795985 ext +33 jean-luc.brun@chu-bordeaux.fr
Contact: Olivier DELORME, CRA (0)557820134 ext +33 olivier.delorme@chu-bordeaux.fr
France
 
NCT01543048
CHUBX 2010/18
No
University Hospital, Bordeaux
University Hospital, Bordeaux
Not Provided
Study Chair: Geneviève CHÊNE, MD-PhD USMR - University Hospital Bordeaux, France
University Hospital, Bordeaux
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP