Trial Information
Evaluation of Initial High Risk Human Papillomavirus (HR-HPV) Viral Load as Predictive Marker for Cervical Intraepithelial Neoplasia Grade 1 (CIN1) Persistence
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.
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
The detection and the quantification of the DNA of the human oncogènes papillomavirus of type 16 and 18
Outcome Time Frame:
48 months
Safety Issue:
Yes
Principal Investigator
Xavier CARCOPINO, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Assistance Publique des Hopitaux de Marseille
Authority:
France: Ministry of Health
Study ID:
2007-A01336-48
NCT ID:
NCT00682552
Start Date:
May 2008
Completion Date:
December 2012
Related Keywords:
- Cervical Intraepithelial Neoplasia
- Neoplasms
- Cervical Intraepithelial Neoplasia
- Uterine Cervical Dysplasia
- Carcinoma in Situ