Significance of the High-risk Hpv Viral Load

Not Applicable

Completed

• Conditions: HPV Infections
• Interventions: Other: 2 cervical takings and 2 sampling of blood

• Registration Number: NCT00682812
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2008-05-20
• Study First Submitted QC: 2008-05-21
• Study First Posted: 2008-05-22
• Study Start: 2008-06-16
• Primary Completion: 2014-04-24
• Status Verified: 2023-05
• Study Completion: 2023-05-23
• Last Update Submitted: 2023-05-23
• Last Update Posted: 2023-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 149

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	2 cervical takings and 2 sampling of blood	105 womens with a cancer of the cervix
2	2 cervical takings and 2 sampling of blood	105 womens with an intraepithelial lesion
1	2 cervical takings and 2 sampling of blood	125 womens with normal cervix

Primary Outcome Measures

Name	Time	Method
Estimate the meaning of a viral load raised in HPV oncogenic	36 months

Secondary Outcome Measures

Name	Time	Method
Estimate the correlation between the viral load in HPV oncogenic and the integration of the viral genome in that of the infected cells	36 months
To estimate the correlation enters the vorale load of the HPV oncogenic and the severity of the cervical hurt	36 months
Estimate the correlation between the viral load of the HPV oncogenic and the level of transcription of the genes coding for oncoproteines E6 and E7	36 months
Estimate the correlation between a viral load raised in HPV oncogenic and a presence of HPV in the circulating blood of the infected patients	36 months

Trial Locations

Locations (1)

Hopital Nord, service de gynécologie-obstétrique; 🇫🇷 Marseille, France