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 Type
Interventional
Primary Outcome
The detection and the quantification of the DNA of the human oncogènes papillomavirus of type 16 and 18
Secondary Outcome
The detection of the markers of the integration of the genome of the human oncogenes papillomavirus (targeted at the gene E2)
Condition
Cervical Intraepithelial Neoplasia
Intervention
A cervico-vaginal cervical smear
Study Arms / Comparison Groups
1
Description: 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
Procedure
Estimated Enrollment
14
Start Date
May 2008
Completion Date
February 2013
Primary Completion Date
February 2013
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 - 65 Years
Accepts Healthy Volunteers
No
Contacts
Xavier CARCOPINO, MD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT00682552
Organization ID
2007-A01336-48
Secondary IDs
2007-31
Responsible Party
Sponsor
Study Sponsor
Assistance Publique Hopitaux De Marseille
Study Sponsor
Xavier CARCOPINO, MD, Principal Investigator, Assistance Publique des Hopitaux de Marseille
Verification Date
August 2014