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Clinical Trials/NCT00682552
NCT00682552
Terminated
Not Applicable

Evaluation of Initial High Risk Human Papillomavirus (HR-HPV) Viral Load as Predictive Marker for Cervical Intraepithelial Neoplasia Grade 1 (CIN1) Persistence

Assistance Publique Hopitaux De Marseille1 site in 1 country14 target enrollmentMay 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cervical Intraepithelial Neoplasia
Sponsor
Assistance Publique Hopitaux De Marseille
Enrollment
14
Locations
1
Primary Endpoint
The detection and the quantification of the DNA of the human oncogènes papillomavirus of type 16 and 18
Status
Terminated
Last Updated
11 years ago

Overview

Brief Summary

Relationship between HPV infection and cervical cancer is well established. Among the HPV types identified to date, 15 are classified as high risk HPV (HR-HPV). Detection of HR-HPV has been proposed to optimize cervical cancer screening.

Detailed Description

A prospective detection and quantification of HR-HPV in patients with proven CIN1 will be performed. Relationship between HR-HPV initial viral load and the CIN1 persistence will be evaluated.

Registry
clinicaltrials.gov
Start Date
May 2008
End Date
February 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • The women whose last one FCV of screening put in evidence a LIEBG of the neck of the womb having been confirmed by the colposcopie.
  • The inclusive patients will be of more than 18 years old. All the patients will be profitable of a regime of Social Security.

Exclusion Criteria

  • The patients whose result of the colposcopie is clashing with that of the FCV of initial screening (normal collar, LIEHG or the other one).
  • The patients having an antecedent of DREGS of the neck of the womb, that this one was or not handled
  • The patients having had a hysterectomy.
  • 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

The detection and the quantification of the DNA of the human oncogènes papillomavirus of type 16 and 18

Time Frame: 48 months

Secondary Outcomes

  • The detection of the markers of the integration of the genome of the human oncogenes papillomavirus (targeted at the gene E2)(48 months)

Study Sites (1)

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