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

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:
NCT00682552
First received: May 19, 2008
Last updated: January 26, 2010
Last verified: January 2010

May 19, 2008
January 26, 2010
May 2008
March 2012   (final data collection date for 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 ]
Same as current
Complete list of historical versions of study NCT00682552 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Evaluation of Initial High Risk Human Papillomavirus (HR-HPV) Viral Load as Predictive Marker for Cervical Intraepithelial Neoplasia Grade 1 (CIN1) Persistence
Evaluation of Initial High Risk Human Papillomavirus (HR-HPV) Viral Load as Predictive Marker for Cervical Intraepithelial Neoplasia Grade 1 (CIN1) Persistence

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Cervical Intraepithelial Neoplasia
Procedure: A cervico-vaginal cervical smear
12 and 18 months after inclusion, a cervico-vaginal cervical smear will be realized and a new examination colposcopique with a new cervical taking for the search(research) and the detection of the HPV 16 and 18.
Experimental: 1

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.

Intervention: Procedure: A cervico-vaginal cervical smear
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
December 2012
March 2012   (final data collection date for primary outcome measure)

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
Female
18 Years to 65 Years
No
Contact: Xavier CARCOPINO, MD 49-196-4672 xcarco@free.fr
Contact: Léon BOUBLI, MD 49-196-4672 leon.boubli@ap-hm.fr
France
 
NCT00682552
2007-A01336-48, 2007-31
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