Malignant Progression of Anal Intra-epithelial Neoplasia in a Cohort of Patients (AIN3)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01877135|
Recruitment Status : Recruiting
First Posted : June 13, 2013
Last Update Posted : March 5, 2015
|Condition or disease|
|Anal AIN3 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"
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Malignant Progression of Anal Intra-epithelial Neoplasia in a Cohort of Patients|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||June 2019|
patients > 18 years, with anal AIN3, without history of anal carcinoma
- at least one anal cancer [ Time Frame: 3-year incidence of anal carcinoma ]the first diagnosis of anal carcinoma
- Observance [ Time Frame: 3 years ]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 ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01877135
|Contact: Laurent Abramowitz, MD||00331 40 25 87 email@example.com|
|Contact: Charlotte Bord, MD||00334 67 67 91 firstname.lastname@example.org|
|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 email@example.com|
|Contact: Charlotte Bord, MD 0033 6 44 07 07 94 firstname.lastname@example.org|
|Principal Investigator: Laurent Abramowitz, MD|
|Principal Investigator:||Laurent Abramowitz, MD||Assistance Publique - Hôpitaux de Paris|