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
Recruitment status was Recruiting
Sponsor:
Assistance Publique Hopitaux De Marseille
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
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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:
MedlinePlus related topics:
Cancer
Drug Information available for:
Human Papillomaviruses
U.S. FDA Resources
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
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:
|
Uterine Cervical Dysplasia Neoplasms Cervical Intraepithelial Neoplasia 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 May 19, 2013