Oncogenous HPV DNA Integration (Intégration De l'ADN Des HPV Oncogènes)
Not Applicable
Completed
- Conditions
- Abnormal Cytology
- Interventions
- Other: all patients included in IDAHO study
- Registration Number
- NCT02864121
- Lead Sponsor
- CHU de Reims
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 407
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
- pregnant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description arm 1 all patients included in IDAHO study all patients included in IDAHO study
- Primary Outcome Measures
Name Time Method presence of high-risk papillomavirus in the analysis of cervical smear during 36 months after inclusion integration of genome of high-risk papillomavirus detected in cervical smear according molecular combing during 36 months after inclusion presence and severity of cervical lesion according to results of cervical smear, colonoscopy and histological analysis during 36 months after inclusion
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Chu de Reims
🇫🇷Reims, France