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Significance of the High-risk Hpv Viral Load

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00682812
First received: May 20, 2008
Last updated: August 27, 2014
Last verified: January 2010
  Purpose

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


Condition Intervention
HPV Infections
Other: 2 cervical takings and 2 sampling of blood

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Significance of the High-risk Hpv Viral Load

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • Estimate the meaning of a viral load raised in HPV oncogenic [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 149
Study Start Date: June 2008
Estimated Study Completion Date: December 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682812

Locations
France
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
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00682812     History of Changes
Other Study ID Numbers: 2007-A01335-48, 2007-30
Study First Received: May 20, 2008
Last Updated: August 27, 2014
Health Authority: France: Ministry of Health

ClinicalTrials.gov processed this record on November 24, 2014