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AIN3: Malignant Progression of Anal Intra-epithelial Neoplasia in a Cohort of Patients

Sponsor
French Society of Coloproctology (Other)
Overall Status
Unknown status
CT.gov ID
NCT01877135
Collaborator
Société Nationale Française de Gastroentérologie (Other)
1,000
Enrollment
1
Location
70
Duration (Months)
14.3
Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase

    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 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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Official Title:
    Malignant Progression of Anal Intra-epithelial Neoplasia in a Cohort of Patients
    Study Start Date :
    Aug 1, 2013
    Anticipated Primary Completion Date :
    Jun 1, 2016
    Anticipated Study Completion Date :
    Jun 1, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    Anal AIN3

    patients > 18 years, with anal AIN3, without history of anal carcinoma

    Outcome Measures

    Primary Outcome Measures

    1. at least one anal cancer [3-year incidence of anal carcinoma]

      the first diagnosis of anal carcinoma

    Secondary Outcome Measures

    1. Observance [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

    2. patient's feelings about his therapeutic care and impact on his emotional life [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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service d'Hépato-gastro-entérologie, Hôpital Bichat, 46 rue Henri Huchard Paris France 75018

    Sponsors and Collaborators

    • French Society of Coloproctology
    • Société Nationale Française de Gastroentérologie

    Investigators

    • Principal Investigator: Laurent Abramowitz, MD, Assistance Publique - Hôpitaux de Paris

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    French Society of Coloproctology
    ClinicalTrials.gov Identifier:
    NCT01877135
    Other Study ID Numbers:
    • 11-LAZ-001
    First Posted:
    Jun 13, 2013
    Last Update Posted:
    Mar 5, 2015
    Last Verified:
    Sep 1, 2013
    Keywords provided by French Society of Coloproctology
    anal carcinoma
    AIN3
    cohort study
    Additional relevant MeSH terms:
    Anus Neoplasms

    Study Results

    No Results Posted as of Mar 5, 2015