Significance of the High-risk Hpv Viral Load

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Assistance Publique Hopitaux De Marseille.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00682812
First received: May 20, 2008
Last updated: January 29, 2010
Last verified: January 2010

May 20, 2008
January 29, 2010
June 2008
April 2011   (final data collection date for primary outcome measure)
Estimate the meaning of a viral load raised in HPV oncogenic [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00682812 on ClinicalTrials.gov Archive Site
  • To estimate the correlation enters the vorale load of the HPV oncogenic and the severity of the cervical hurt [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Significance of the High-risk Hpv Viral Load
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.

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
Interventional
Not Provided
Intervention Model: Parallel Assignment
Masking: Open Label
HPV Infections
  • 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
  • Active Comparator: 1
    125 womens with normal cervix
    Intervention: Other: 2 cervical takings and 2 sampling of blood
  • 2
    105 womens with an intraepithelial lesion
    Intervention: Other: 2 cervical takings and 2 sampling of blood
  • 3
    105 womens with a cancer of the cervix
    Intervention: Other: 2 cervical takings and 2 sampling of blood
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
335
December 2011
April 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Xavier CARCOPINO, MD 49-196-4672 xcarco@free.fr
Contact: Aubert AGOSTINI, MD 49-138-0775 aubert.agostini@mail.ap-hm.fr
France
 
NCT00682812
2007-A01335-48, 2007-30
No
Assistance Publique des Hopitaux de Marseille
Assistance Publique Hopitaux De Marseille
Not Provided
Principal Investigator: Xavier CARCOPINO, MD Assistance Publique des Hopitaux de Marseille
Assistance Publique Hopitaux De Marseille
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP