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Significance of the High-risk Hpv Viral Load

Sponsor
Assistance Publique Hopitaux De Marseille (Other)
Overall Status
Unknown status
CT.gov ID
NCT00682812
Collaborator
(none)
149
Enrollment
1
Location
3
Arms
78
Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
149 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Official Title:
Significance of the High-risk Hpv Viral Load
Study Start Date :
Jun 1, 2008
Actual Primary Completion Date :
Apr 1, 2014
Anticipated Study Completion Date :
Dec 1, 2014

Arms and Interventions

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

105 womens with an intraepithelial lesion

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: 3

105 womens with a cancer of the cervix

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

Outcome Measures

Primary Outcome Measures

  1. Estimate the meaning of a viral load raised in HPV oncogenic [36 months]

Secondary Outcome Measures

  1. To estimate the correlation enters the vorale load of the HPV oncogenic and the severity of the cervical hurt [36 months]

  2. 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]

  3. 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]

  4. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hopital Nord, service de gynécologie-obstétrique Marseille France 13015

Sponsors and Collaborators

  • Assistance Publique Hopitaux De Marseille

Investigators

  • Principal Investigator: Xavier CARCOPINO, MD, Assistance Publique des Hopitaux de Marseille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00682812
Other Study ID Numbers:
  • 2007-A01335-48
  • 2007-30
First Posted:
May 22, 2008
Last Update Posted:
Aug 28, 2014
Last Verified:
Jan 1, 2010
Additional relevant MeSH terms:
Papillomavirus Infections

Study Results

No Results Posted as of Aug 28, 2014