Malignant Progression of Anal Intra-epithelial Neoplasia in a Cohort of Patients (NCT01877135) | Clinical Trial Compass
UnknownNot Applicable
Malignant Progression of Anal Intra-epithelial Neoplasia in a Cohort of Patients
France1,000 participantsStarted 2013-08
Plain-language 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 prospective cohort study (starting in 2013) with new diagnoses of anal AIN3 lesion. The main outcome is histology proven AC. The 3-years incidence rate of AC will be calculated. Factors associated with AC will be estimated using a multivariate Cox regression model.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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 Criteria:
* 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