Prognostic Value of Human Papillomavirus (HPV) Detection in Cervical Intra-epithelial Neoplasia (CIN) Recurrence After Conization (SUIVICOL)
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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) |
- 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
- 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: | October 2015 |
| Estimated Primary Completion Date: | October 2015 (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 |
Women with CIN3 treated by conization
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| 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 | |
| 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 | |
| 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 14, 2013 |
| 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:
|
Neoplasms Recurrence Cervical Intraepithelial Neoplasia Carcinoma in Situ Disease Attributes |
Pathologic Processes Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 23, 2013