Significance of the High-risk Hpv Viral Load

HPV Infections Clinical Trial

Official title:

Significance of the High-risk Hpv Viral Load

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00682812
• Other study ID #: 2007-A01335-48
• Secondary ID: 2007-30
• Status: Completed
• Phase: N/A
• Start date: June 16, 2008
• Est. completion date: May 23, 2023

Study information

• Verified date: May 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: May 23, 2023
• Est. primary completion date: April 24, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HPV Infections
• Papillomavirus Infections

Intervention

Other:
• 2 cervical takings and 2 sampling of blood
2 cervical takings 2 sampling of blood before and after the total hysterectomy
• 2 cervical takings and 2 sampling of blood
cervical taking during the cervical conization 2 sampling of blood before and after the intervention
• 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

Locations

Country	Name	City	State
France	Hopital Nord, service de gynécologie-obstétrique	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimate the meaning of a viral load raised in HPV oncogenic		36 months
Secondary	To estimate the correlation enters the vorale load of the HPV oncogenic and the severity of the cervical hurt		36 months
Secondary	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
Secondary	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
Secondary	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