Significance of the High-risk Hpv Viral Load

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

Study Overview

• Status: Completed
• Conditions: HPV Infections
• Intervention / Treatment: Other: 2 cervical takings and 2 sampling of blood; Other: 2 cervical takings and 2 sampling of blood; Other: 2 cervical takings and 2 sampling of blood

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 Type: Interventional
• Enrollment (Actual): 149
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13015
    • Hopital Nord, service de gynécologie-obstétrique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; 125 womens with normal cervix	Other: 2 cervical takings and 2 sampling of blood; 2 cervical takings; 2 sampling of blood before and after the total hysterectomy; Other: 2 cervical takings and 2 sampling of blood; cervical taking during the cervical conization; 2 sampling of blood before and after the intervention; 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
Other: 2; 105 womens with an intraepithelial lesion	Other: 2 cervical takings and 2 sampling of blood; 2 cervical takings; 2 sampling of blood before and after the total hysterectomy; Other: 2 cervical takings and 2 sampling of blood; cervical taking during the cervical conization; 2 sampling of blood before and after the intervention; 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
Other: 3; 105 womens with a cancer of the cervix	Other: 2 cervical takings and 2 sampling of blood; 2 cervical takings; 2 sampling of blood before and after the total hysterectomy; Other: 2 cervical takings and 2 sampling of blood; cervical taking during the cervical conization; 2 sampling of blood before and after the intervention; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Estimate the meaning of a viral load raised in HPV oncogenic	36 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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 the viral load in HPV oncogenic and the integration of the viral genome in that of the infected cells	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

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Principal Investigator: Xavier CARCOPINO, MD, Assistance Publique des Hôpitaux de Marseille

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2008
• Primary Completion (Actual): April 24, 2014
• Study Completion (Actual): May 23, 2023

Study Registration Dates

• First Submitted: May 20, 2008
• First Submitted That Met QC Criteria: May 21, 2008
• First Posted (Estimate): May 22, 2008

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Disease Attributes; DNA Virus Infections; Tumor Virus Infections; Urogenital Diseases; Genital Diseases; Papillomavirus Infections
• Other Study ID Numbers: 2007-A01335-48; 2007-30