Status:
UNKNOWN
Malignant Progression of Anal Intra-epithelial Neoplasia in a Cohort of Patients
Lead Sponsor:
French Society of Coloproctology
Collaborating Sponsors:
Société Nationale Française de Gastroentérologie
Conditions:
Anal AIN3
Anal Carcinoma
Eligibility:
All Genders
18+ years
Brief Summary
Evaluation of the 3-years anal carcinoma (AC) incidence in patient with anal AIN3 lesions, and factors associated with this AC. A retrospective cohort study will be conducted (2000-2013) followed by a...
Detailed Description
"Background : Incidence of anal carcinoma (AC) is considerably increasing, but no data on risk of AC in patient with anal AIN3 lesions are available, nor french recommendations about screening and tre...
Eligibility Criteria
Inclusion
- To be included in the cohort, patients have to:
- \- have an anal AIN3 (including Bowen's disease) diagnosed by histology (screening population, post-operative discovery…)
- Aposteriori for patients with a history of anal AIN3 complicated or not by an anal cancer. These cases will be identified from data bases of anatomopathology laboratories in hospitals since January 1st 2000.
- At the diagnostic for the new anal AIN3 Units care involved in the study are those involved in the follow-up of patients with anal pathologies en France, especially anal cancer. Samples are analyzed by the laboratories of anatomopathology of the hospitals where the patients are diagnosed. These points make the histological data bases reliable and allow clearly identifying cases of anal ain3 retrospectively since 2000.
- Taking in account the number and quality of the units care involved in the study and the way cases are identified, we think our recruitment will be exhaustive in France, to limit selection bias.
- \- Patient's non opposition to study
Exclusion
- history of anal carcinoma without any history of anal AIN3 lesion
- impossible follow-up for the duration of the study (3 years or more)
- patient aged under 18
Key Trial Info
Start Date :
August 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2019
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT01877135
Start Date
August 1 2013
End Date
June 1 2019
Last Update
March 5 2015
Active Locations (1)
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1
Service d'Hépato-gastro-entérologie, Hôpital Bichat, 46 rue Henri Huchard
Paris, Paris, France, 75018