Significance of the High-risk Hpv Viral Load

NCT ID: NCT00682812

Last Updated: 2023-05-24

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

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-16

Study Completion Date

2023-05-23

Brief Summary

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The aim of this study is to evaluate the significance of an elevated high-risk HPV (HR-HPV) viral load.

Detailed Description

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We will particularly evaluate if the HR-HPV viral load:

* Is correlated to the transcription of the genes of the oncoproteins E6 and E7
* Is predictive of the integration of the virus in infected cells
* Is predictive of the presence of HPV in patients' blood
* Influences the local and systemic immunologic response

Conditions

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HPV Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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1

125 womens with normal cervix

Group Type ACTIVE_COMPARATOR

2 cervical takings and 2 sampling of blood

Intervention Type OTHER

* 2 cervical takings
* 2 sampling of blood before and after the total hysterectomy

2

105 womens with an intraepithelial lesion

Group Type OTHER

2 cervical takings and 2 sampling of blood

Intervention Type OTHER

* cervical taking during the cervical conization
* 2 sampling of blood before and after the intervention

3

105 womens with a cancer of the cervix

Group Type OTHER

2 cervical takings and 2 sampling of blood

Intervention Type OTHER

* cervical taking during the pelvien examination under general anesthetic realized systematically during the balance sheet of pre-therapeutic evaluation
* 2 sampling of blood before and after the intervention

Interventions

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2 cervical takings and 2 sampling of blood

* 2 cervical takings
* 2 sampling of blood before and after the total hysterectomy

Intervention Type OTHER

2 cervical takings and 2 sampling of blood

* cervical taking during the cervical conization
* 2 sampling of blood before and after the intervention

Intervention Type OTHER

2 cervical takings and 2 sampling of blood

* cervical taking during the pelvien examination under general anesthetic realized systematically during the balance sheet of pre-therapeutic evaluation
* 2 sampling of blood before and after the intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* The women consulting for the therapeutic care (by hysterectomy or conization) of a LIEHG or a cervical cancer (carcinoma epidermoid or adenocarcinoma) confirmed by the anatomopathologique analysis of a preoperative cervical biopsy.
* The women having a normal cervix consulting for the surgical care by hysterectomy of a good-hearted pathology of the womb. The normality of the cervix will be confirmed by the anatomopathologique analysis of the detail of hysterectomy
* The patients participating in this study will have to be of more than 18 years old. All the subjects will be profitable of a regime of Social Security.

Exclusion Criteria

* The patients having a LIEBG
* 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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xavier CARCOPINO, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique des Hopitaux de Marseille

Locations

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Hopital Nord, service de gynécologie-obstétrique

Marseille, , France

Site Status

Countries

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France

Other Identifiers

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2007-30

Identifier Type: -

Identifier Source: secondary_id

2007-A01335-48

Identifier Type: -

Identifier Source: org_study_id

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