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
  Purpose

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.


Condition Intervention
CIN2/3 Recurrence
Other: Study Follow-Up

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Biospecimen Retention:   Samples With DNA

Cervical samples


Estimated Enrollment: 300
Study Start Date: March 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women with CIN3 treated by conization

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01543048

Contacts
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

Locations
France
CHU de Bordeaux Recruiting
Bordeaux, France
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   
Principal Investigator: Jean-Luc BRUN, MD         
Sub-Investigator: Jacques HOROVITZ, MD         
Sub-Investigator: Claude HOCKE, MD         
Sub-Investigator: Claudine MATHIEU, MD-PhD         
Sub-Investigator: Vanessa CONRI, MD         
CHU de Limoges, Hôpital Mère Enfant Not yet recruiting
Limoges, France
Contact: Yves AUBARD, MD-PhD    (0)555056115 ext +33    yves.aubard@unilim.fr   
Principal Investigator: Yves AUBARD, MD-PhD         
Sub-Investigator: Hugues CALY, MD         
CHU de Toulouse, Hôpital Paule de Viguier Not yet recruiting
Toulouse, France
Contact: Alain BERREBI, MD    (0)567771108 ext +33    berrebi.a@chu-toulouse.fr   
Principal Investigator: Alain BERREBI, MD         
Sub-Investigator: Géraldine CARTRON, MD         
CHU de Toulouse, Hôpital Rangueil Not yet recruiting
Toulouse, France
Contact: Jacques RIMAILHO, MD    (0)561323715 ext +33    rimailho.j@chu-toulouse.fr   
Principal Investigator: Jacques RIMAILHO, MD         
Sub-Investigator: Fabien VIDAL, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Study Chair: Geneviève CHÊNE, MD-PhD USMR - University Hospital Bordeaux, France
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01543048     History of Changes
Other Study ID Numbers: CHUBX 2010/18
Study First Received: February 27, 2012
Last Updated: May 7, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Human Papilloma Virus (HPV)
Virological tests
CIN3
Cervical cancer
Conization
within women treated by conization for a CIN3

Additional relevant MeSH terms:
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Recurrence
Carcinoma
Disease Attributes
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Pathologic Processes

ClinicalTrials.gov processed this record on October 30, 2014