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Clinical Trials/NCT00682812
NCT00682812CompletedNot Applicable

Significance of the High-risk Hpv Viral Load

Assistance Publique Hopitaux De Marseille2 sites in 1 country149 target enrollmentStarted: June 16, 2008Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
149
Locations
2
Primary Endpoint
Estimate the meaning of a viral load raised in HPV oncogenic
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

Estimate the meaning of a viral load raised in HPV oncogenic

Time Frame: 36 months

Secondary Outcomes

  • 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)
  • 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 a viral load raised in HPV oncogenic and a presence of HPV in the circulating blood of the infected patients(36 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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