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

CHU de Reims407 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

407

Conditions

Abnormal Cytology

Interventions

all patients included in IDAHO studyOTHER

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Chu de Reims

Reims, France

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

Data from ClinicalTrials.gov

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