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

NCT01543048 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 106

Last updated 2017-08-24

No results posted yet for this study

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.

Conditions

  • CIN2/3 Recurrence

Interventions

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.

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Geneviève CHÊNE, MD-PhD · USMR - University Hospital Bordeaux, France

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-06
Primary Completion
2016-08-01
Completion
2016-08-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01543048 on ClinicalTrials.gov