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| Descriptive Information Fields | |||||||||
| 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. |
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| 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. |
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| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Diagnostic, Open Label, Single Group Assignment | ||||||||
| Primary Outcome Measure † | 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 Measure † | 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 ] | ||||||||
| Condition † | Cervical Intraepithelial Neoplasia | ||||||||
| Intervention † | Procedure: A cervico-vaginal cervical smear | ||||||||
| MEDLINE PMIDs | |||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 600 | ||||||||
| Start Date † | May 2008 | ||||||||
| Completion Date | December 2012 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | France | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00682552 | ||||||||
| Organization ID | 2007-A01336-48 | ||||||||
| Secondary IDs †† | 2007-31 | ||||||||
| Study Sponsor † | Assistance Publique Hopitaux De Marseille | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Assistance Publique Hopitaux De Marseille | ||||||||
| Verification Date | May 2008 | ||||||||
| First Received Date † | May 19, 2008 | ||||||||
| Last Updated Date | May 22, 2008 | ||||||||
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