Malignant Progression of Anal Intra-epithelial Neoplasia in a Cohort of Patients (AIN3)
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.
|Study Design:||Observational Model: Cohort|
|Official Title:||Malignant Progression of Anal Intra-epithelial Neoplasia in a Cohort of Patients|
- at least one anal cancer [ Time Frame: 3-year incidence of anal carcinoma ] [ Designated as safety issue: No ]the first diagnosis of anal carcinoma
- Observance [ Time Frame: 3 years ] [ Designated as safety issue: No ]Observance defined by at least one consult a year, in case of history anal dysplasia, or 2 consults a year, in case of persistence of anal dysplasia
- patient's feelings about his therapeutic care and impact on his emotional life [ Time Frame: 3 years ] [ Designated as safety issue: No ]Patient's feelings about his therapeutic care and impact on his emotional life will be evaluated with a single question with an analogical visual scale from 0 (I'm feeling very bad) to 10 (I'm feeling very good)
Biospecimen Retention: Samples Without DNA
A liquid phase anal smear
|Study Start Date:||August 2013|
|Estimated Study Completion Date:||June 2019|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
patients > 18 years, with anal AIN3, without history of anal carcinoma
"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 treatment of anal AIN3 lesions.
Objective : Evaluation of the AC incidence in patient with anal AIN3 lesions, and factors associated with this AC.
Population : Patients with a diagnosis of anal AIN3 lesion will be included and followed for 3 years. Patients with past history of AC won't be included.
Study design : Retrospective cohort study will be conducted from 2000 using diagnostic codes of anal AIN3 lesion in histo-pathology departments. Then a prospective cohort study will be conducted with new diagnoses of anal AIN3 lesion.
Outcome : The main outcome is histology proven AC. AC identification can be done either by using diagnostic codes of AC in histo-pathology departments (for retrospective cases), or prospectively.
Statistics : The incidence rate of AC will be calculated. Factors associated with AC will be estimated using a multivariate Cox regression model.
Number of patients : 1000 Number of centers : 35 Length of follow-up: 3 years at least Length of study : 3 years of inclusion and 3 years of follow-up at least"
Please refer to this study by its ClinicalTrials.gov identifier: NCT01877135
|Contact: Laurent Abramowitz, MD||00331 40 25 87 firstname.lastname@example.org|
|Contact: Charlotte Bord, MD||00334 67 67 91 email@example.com|
|Service d'Hépato-gastro-entérologie, Hôpital Bichat, 46 rue Henri Huchard||Recruiting|
|Paris, France, 75018|
|Contact: Laurent Abramowitz, MD 0033 1 40 25 72 02 firstname.lastname@example.org|
|Contact: Charlotte Bord, MD 0033 6 44 07 07 94 email@example.com|
|Principal Investigator: Laurent Abramowitz, MD|
|Principal Investigator:||Laurent Abramowitz, MD||Assistance Publique - Hôpitaux de Paris|