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

Tracking Information

First Received Date ^ICMJE

May 19, 2008

Last Updated Date

January 14, 2009

Start Date ^ICMJE

May 2008

Estimated Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00682552 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Open Label, Single Group Assignment

Condition ^ICMJE

Cervical Intraepithelial Neoplasia

Intervention ^ICMJE

Procedure: A cervico-vaginal cervical smear

Study Arms / Comparison Groups

Experimental:

A cervico-vaginal cervical smear will be realized before every colposcopique examination.

A new cervical taking for the search(research) and the detection of the HPV 16 and 18 will be realized.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

600

Estimated Completion Date

December 2012

Estimated Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Contacts ^ICMJE

Contact: Xavier CARCOPINO, MD	49-196-4672	xcarco@free.fr
Contact: Léon BOUBLI, MD	49-196-4672	leon.boubli@ap-hm.fr

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00682552

Responsible Party

Assistance Publique des Hopitaux de Marseille, Assistance Publique des Hopitaux de Marseille

Study ID Numbers ^ICMJE

2007-A01336-48, 2007-31

Study Sponsor ^ICMJE

Assistance Publique Hopitaux De Marseille

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Xavier CARCOPINO, MD

Assistance Publique des Hopitaux de Marseille

Information Provided By

Assistance Publique Hopitaux De Marseille

Verification Date

January 2009

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