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

This study is currently recruiting participants.
Study NCT00682552.   Last updated on May 22, 2008.   Information provided by Assistance Publique Hopitaux De Marseille

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Descriptive Information Fields
Brief Title  Evaluation of Initial High Risk Human Papillomavirus (HR-HPV) Viral Load as Predictive Marker for Cervical Intraepithelial Neoplasia Grade 1 (CIN1) Persistence
Official Title  Evaluation of Initial High Risk Human Papillomavirus (HR-HPV) Viral Load as Predictive Marker for Cervical Intraepithelial Neoplasia Grade 1 (CIN1) Persistence
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.

Study Phase
Study Type  Interventional
Study Design  Diagnostic, Open Label, Single Group Assignment
Primary Outcome Measure  The detection and the quantification of the DNA of the human oncogènes papillomavirus of type 16 and 18 [ Time Frame: 48 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure  The detection of the markers of the integration of the genome of the human oncogenes papillomavirus (targeted at the gene E2) [ Time Frame: 48 months ] [ Designated as safety issue: Yes ]
Condition  Cervical Intraepithelial Neoplasia
Intervention  Procedure: A cervico-vaginal cervical smear
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  600
Start Date  May 2008
Completion Date December 2012
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
Gender Female
Ages 18 Years to 65 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Xavier CARCOPINO, MD     49-196-4672     xcarco@free.fr    
Contact: Léon BOUBLI, MD     49-196-4672     leon.boubli@ap-hm.fr    
Location Countries  France
Administrative Information Fields
NCT ID  NCT00682552
Organization ID 2007-A01336-48
Secondary IDs †† 2007-31
Study Sponsor  Assistance Publique Hopitaux De Marseille
Collaborators ††
Investigators 
Principal Investigator:     Xavier CARCOPINO, MD     Assistance Publique des Hopitaux de Marseille    
Information Provided By Assistance Publique Hopitaux De Marseille
Verification Date May 2008
First Received Date  May 19, 2008
Last Updated Date May 22, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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