Back to resultsEvaluation of Initial High Risk Human Papillomavirus (HR-HPV) Viral Load as Predictive Marker for Cervical Intraepithelial Neoplasia Grade 1 (CIN1) Persistence
Primary Purpose
Cervical Intraepithelial Neoplasia
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
A cervico-vaginal cervical smear
Sponsored by
About this trial
This is an interventional diagnostic trial for Cervical Intraepithelial Neoplasia
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
Sites / Locations
- Hopital Nord- Service de gynécologie-obstétrique
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm 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.
Outcomes
Primary Outcome Measures
The detection and the quantification of the DNA of the human oncogènes papillomavirus of type 16 and 18
Secondary Outcome Measures
The detection of the markers of the integration of the genome of the human oncogenes papillomavirus (targeted at the gene E2)
Full Information
NCT ID
NCT00682552
First Posted
May 19, 2008
Last Updated
August 27, 2014
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT00682552
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Study Start Date
May 2008 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Intraepithelial Neoplasia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
A cervico-vaginal cervical smear
Intervention Description
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.
Primary Outcome Measure Information:
Title
The detection and the quantification of the DNA of the human oncogènes papillomavirus of type 16 and 18
Time Frame
48 months
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier CARCOPINO, MD
Organizational Affiliation
Assistance Publique des Hopitaux de Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Nord- Service de gynécologie-obstétrique
City
Marseille
ZIP/Postal Code
13015
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Initial High Risk Human Papillomavirus (HR-HPV) Viral Load as Predictive Marker for Cervical Intraepithelial Neoplasia Grade 1 (CIN1) Persistence
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