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Significance of the High-risk Hpv Viral Load

Primary Purpose

HPV Infections

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
2 cervical takings and 2 sampling of blood
2 cervical takings and 2 sampling of blood
2 cervical takings and 2 sampling of blood
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for HPV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Nord, service de gynécologie-obstétrique

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Other

Other

Arm Label

1

2

3

Arm Description

125 womens with normal cervix

105 womens with an intraepithelial lesion

105 womens with a cancer of the cervix

Outcomes

Primary Outcome Measures

Estimate the meaning of a viral load raised in HPV oncogenic

Secondary Outcome Measures

To estimate the correlation enters the vorale load of the HPV oncogenic and the severity of the cervical hurt
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
Estimate the correlation between the viral load in HPV oncogenic and the integration of the viral genome in that of the infected cells
Estimate the correlation between a viral load raised in HPV oncogenic and a presence of HPV in the circulating blood of the infected patients

Full Information

First Posted
May 20, 2008
Last Updated
May 23, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT00682812
Brief Title
Significance of the High-risk Hpv Viral Load
Official Title
Significance of the High-risk Hpv Viral Load
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 16, 2008 (Actual)
Primary Completion Date
April 24, 2014 (Actual)
Study Completion Date
May 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HPV Infections

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
149 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
125 womens with normal cervix
Arm Title
2
Arm Type
Other
Arm Description
105 womens with an intraepithelial lesion
Arm Title
3
Arm Type
Other
Arm Description
105 womens with a cancer of the cervix
Intervention Type
Other
Intervention Name(s)
2 cervical takings and 2 sampling of blood
Intervention Description
2 cervical takings 2 sampling of blood before and after the total hysterectomy
Intervention Type
Other
Intervention Name(s)
2 cervical takings and 2 sampling of blood
Intervention Description
cervical taking during the cervical conization 2 sampling of blood before and after the intervention
Intervention Type
Other
Intervention Name(s)
2 cervical takings and 2 sampling of blood
Intervention Description
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 Outcome Measure Information:
Title
Estimate the meaning of a viral load raised in HPV oncogenic
Time Frame
36 months
Secondary Outcome Measure Information:
Title
To estimate the correlation enters the vorale load of the HPV oncogenic and the severity of the cervical hurt
Time Frame
36 months
Title
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
Title
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
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier CARCOPINO, MD
Organizational Affiliation
Assistance Publique des Hopitaux de Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Nord, service de gynécologie-obstétrique
City
Marseille
ZIP/Postal Code
13015
Country
France

12. IPD Sharing Statement

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Significance of the High-risk Hpv Viral Load

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