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

Sponsored by:	Assistance Publique Hopitaux De Marseille
Information provided by:	Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:	NCT00682552

Purpose

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.

Condition	Intervention
Cervical Intraepithelial Neoplasia	Procedure: A cervico-vaginal cervical smear

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment
Official Title:	Evaluation of Initial High Risk Human Papillomavirus (HR-HPV) Viral Load as Predictive Marker for Cervical Intraepithelial Neoplasia Grade 1 (CIN1) Persistence

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

Primary Outcome Measures:

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 Measures:

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 ]

Estimated Enrollment:	600
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: 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.	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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682552

Contacts

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

Locations

France
Hopital Nord- Service de gynécologie-obstétrique	Recruiting
MARSEILLE, France, 13015
Contact: Xavier CARCOPINO, MD 49-196-4672 xcarco@free.fr

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

Investigators

Principal Investigator:

Xavier CARCOPINO, MD

Assistance Publique des Hopitaux de Marseille

More Information

Responsible Party:	Assistance Publique des Hopitaux de Marseille ( Assistance Publique des Hopitaux de Marseille )
Study ID Numbers:	2007-A01336-48, 2007-31
Study First Received:	May 19, 2008
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00682552
Health Authority:	France: Ministry of Health

Study placed in the following topic categories:

Genital Diseases, Female
Uterine Cervical Diseases
Precancerous Conditions
Cervical intraepithelial neoplasia
Carcinoma in Situ

Uterine Diseases
Uterine Cervical Dysplasia
Neoplasms, Glandular and Epithelial
Carcinoma
Cervical Intraepithelial Neoplasia

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on February 11, 2009