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

Study Overview
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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.

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.

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

Conditions
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Cervical Intraepithelial Neoplasia

Intervention / Treatment
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* Procedure: A cervico-vaginal cervical smear


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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. | Procedure: A cervico-vaginal cervical smear<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The detection and the quantification of the DNA of the human oncogènes papillomavirus of type 16 and 18 |  | 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The detection of the markers of the integration of the genome of the human oncogenes papillomavirus (targeted at the gene E2) |  | 48 months |