Evaluation of Initial High Risk Human Papillomavirus (HR-HPV) Viral Load as Predictive Marker for Cervical Intraepithelial Neoplasia Grade 1 (CIN1) Persistence

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

TERMINATED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2013-02-28

Brief Summary

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Relationship between HPV infection and cervical cancer is well established. Among the HPV types identified to date, 15 are classified as high risk HPV (HR-HPV). Detection of HR-HPV has been proposed to optimize cervical cancer screening.

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Detailed Description

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A prospective detection and quantification of HR-HPV in patients with proven CIN1 will be performed. Relationship between HR-HPV initial viral load and the CIN1 persistence will be evaluated.

Conditions

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Cervical Intraepithelial Neoplasia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

A cervico-vaginal cervical smear will be realized before every colposcopique examination.

A new cervical taking for the search(research) and the detection of the HPV 16 and 18 will be realized.

Group Type EXPERIMENTAL

A cervico-vaginal cervical smear

Intervention Type PROCEDURE

12 and 18 months after inclusion, a cervico-vaginal cervical smear will be realized and a new examination colposcopique with a new cervical taking for the search(research) and the detection of the HPV 16 and 18.

Interventions

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A cervico-vaginal cervical smear

12 and 18 months after inclusion, a cervico-vaginal cervical smear will be realized and a new examination colposcopique with a new cervical taking for the search(research) and the detection of the HPV 16 and 18.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* The women whose last one FCV of screening put in evidence a LIEBG of the neck of the womb having been confirmed by the colposcopie.
* The inclusive patients will be of more than 18 years old. All the patients will be profitable of a regime of Social Security.

Exclusion Criteria

* The patients whose result of the colposcopie is clashing with that of the FCV of initial screening (normal collar, LIEHG or the other one).
* The patients having an antecedent of DREGS of the neck of the womb, that this one was or not handled
* The patients having had a hysterectomy.
* The patients incapable to receive the information enlightened on the progress and the objectives of the study
* The patients not having signed enlightened assent

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No