Association Between High-risk HPV Genome Integration Detected by Molecular Combing and Cervical Lesions Severity and/or Evolution
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Abnormal Cytology
- Sponsor
- CHU de Reims
- Enrollment
- 407
- Locations
- 1
- Primary Endpoint
- presence of high-risk papillomavirus in the analysis of cervical smear
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
High-risk human papillomavirus (HR-HPV) are involved in cervical cancer development. Integration of HR-HPV DNA in cellular genomes is considered as a major event in the cervical cancer development. The aim of this study is to validate the integration of the HPV-HR as an appropriate biomarker of the severity of precancerous lesions and progression of cervical lesions towards cervical cancer. HR-HPV integration status will be analyzed by Molecular Combing technology, which allows direct and high-resolution visualization of the integration of high-risk HPV genomes.
Investigators
Eligibility Criteria
Inclusion Criteria
- •women aged from 25 to 65 years
- •consulting in a gynecological-obstetrical service of one of the investigator center for a colposcopy reflex after an abnormal cytology dating of less than 6 months and more than 1 month
- •signature of the informed consent
- •affiliated to Social Security
Exclusion Criteria
- •women vaccinated against HPV
- •women who received a treatment for a cervical pathology followed by a normal
- •women with a known positive HIV test
- •women suffering from a chronic pathology that generate immunosuppression
- •Women currently treated with immunosuppressors
- •Women treated with corticoids currently or dating of less than 6 months
- •protected by law
Outcomes
Primary Outcomes
presence of high-risk papillomavirus in the analysis of cervical smear
Time Frame: during 36 months after inclusion
integration of genome of high-risk papillomavirus detected in cervical smear according molecular combing
Time Frame: during 36 months after inclusion
presence and severity of cervical lesion according to results of cervical smear, colonoscopy and histological analysis
Time Frame: during 36 months after inclusion