Abnormal Cytology Clinical Trial
— IDAHOOfficial title:
Association Between High-risk HPV Genome Integration Detected by Molecular Combing and Cervical Lesions Severity and/or Evolution
NCT number | NCT02864121 |
Other study ID # | PI15088 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 2015 |
Est. completion date | December 17, 2019 |
Verified date | June 2020 |
Source | CHU de Reims |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 407 |
Est. completion date | December 17, 2019 |
Est. primary completion date | December 17, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 25 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Chu de Reims | Reims |
Lead Sponsor | Collaborator |
---|---|
CHU de Reims |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | presence of high-risk papillomavirus in the analysis of cervical smear | during 36 months after inclusion | ||
Primary | integration of genome of high-risk papillomavirus detected in cervical smear according molecular combing | during 36 months after inclusion | ||
Primary | presence and severity of cervical lesion according to results of cervical smear, colonoscopy and histological analysis | during 36 months after inclusion |