Overview

This trial is active, not recruiting.

Condition hpv infections
Treatments 2 cervical takings and 2 sampling of blood
Sponsor Assistance Publique Hopitaux De Marseille
Start date June 2008
End date April 2014
Trial size 149 participants
Trial identifier NCT00682812, 2007-30, 2007-A01335-48

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Arm
(Active Comparator)
125 womens with normal cervix
2 cervical takings and 2 sampling of blood
2 cervical takings 2 sampling of blood before and after the total hysterectomy
(Other)
105 womens with an intraepithelial lesion
2 cervical takings and 2 sampling of blood
cervical taking during the cervical conization 2 sampling of blood before and after the intervention
(Other)
105 womens with a cancer of the cervix
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

Primary Outcomes

Measure
Estimate the meaning of a viral load raised in HPV oncogenic
time frame: 36 months

Secondary Outcomes

Measure
To estimate the correlation enters the vorale load of the HPV oncogenic and the severity of the cervical hurt
time frame: 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
time frame: 36 months
Estimate the correlation between the viral load in HPV oncogenic and the integration of the viral genome in that of the infected cells
time frame: 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
time frame: 36 months

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Significance of the High-risk Hpv Viral Load
Principal investigator Xavier CARCOPINO, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Assistance Publique Hopitaux De Marseille.