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Sponsored by: |
Assistance Publique Hopitaux De Marseille |
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Information provided by: | Assistance Publique Hopitaux De Marseille |
ClinicalTrials.gov Identifier: | NCT00682552 |
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 |
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Cervical Intraepithelial Neoplasia |
Procedure: A cervico-vaginal cervical smear |
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 |
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 |
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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.
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Xavier CARCOPINO, MD | 49-196-4672 | xcarco@free.fr |
Contact: Léon BOUBLI, MD | 49-196-4672 | leon.boubli@ap-hm.fr |
France | |
Hopital Nord- Service de gynécologie-obstétrique | Recruiting |
MARSEILLE, France, 13015 | |
Contact: Xavier CARCOPINO, MD 49-196-4672 xcarco@free.fr |
Principal Investigator: | Xavier CARCOPINO, MD | Assistance Publique des Hopitaux de Marseille |
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 |
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 |
Neoplasms Neoplasms by Histologic Type |