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 |