Oncogenous HPV DNA Integration (Intégration De l'ADN Des HPV Oncogènes) (IDAHO)

CHU de Reims

Status: Completed

Conditions: Abnormal Cytology

Treatments: Other: all patients included in IDAHO study

Study type: Interventional

Funder types: Other

Identifiers

NCT02864121

PI15088

Details and patient eligibility

About

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.

Enrollment: 407 patients

Sex: Female

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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407 participants in 1 patient group

arm 1

Experimental group

Description:

all patients included in IDAHO study

Treatment:

Other: all patients included in IDAHO study