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

August 22, 2017 updated by: University Hospital, Bordeaux

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • CHU de Bordeaux
      • Limoges, France
        • CHU de Limoges, Hôpital Mère Enfant
      • Toulouse, France
        • CHU de Toulouse, Hôpital Paule de Viguier
      • Toulouse, France
        • CHU de Toulouse, Hôpital Rangueil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with CIN3 treated by conization

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women with CIN3 treated by conization
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of CIN2/3 diagnosed on colposcopy-directed biopsy
Time Frame: For each patient, 24 month after inclusion
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of CIN2/3 diagnosis tests
Time Frame: For each patient, 24 month after inclusion

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)
For each patient, 24 month after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Study Chair: Geneviève CHÊNE, MD-PhD, USMR - University Hospital Bordeaux, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2012

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

February 27, 2012

First Submitted That Met QC Criteria

March 1, 2012

First Posted (Estimate)

March 2, 2012

Study Record Updates

Last Update Posted (Actual)

August 24, 2017

Last Update Submitted That Met QC Criteria

August 22, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2010/18

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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