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
  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

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

Resource links provided by NLM:


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
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Assistance Publique des Hopitaux de Marseille
ClinicalTrials.gov Identifier: NCT00682552     History of Changes
Other Study ID Numbers: 2007-A01336-48, 2007-31
Study First Received: May 19, 2008
Last Updated: January 26, 2010
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Neoplasms
Cervical Intraepithelial Neoplasia
Uterine Cervical Dysplasia
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Precancerous Conditions
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 25, 2014