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

NCT ID: NCT02864121

Last Updated: 2020-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

407 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2019-12-17

Brief Summary

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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

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Conditions

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Abnormal Cytology

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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arm 1

all patients included in IDAHO study

Group Type EXPERIMENTAL

all patients included in IDAHO study

Intervention Type OTHER

Interventions

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all patients included in IDAHO study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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CHU de Reims

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu de Reims

Reims, , France

Site Status

Countries

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France

Other Identifiers

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PI15088

Identifier Type: -

Identifier Source: org_study_id

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