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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by French Society of Coloproctology
Sponsor:
Collaborator:
Société Nationale Française de Gastroentérologie
Information provided by (Responsible Party):
French Society of Coloproctology
ClinicalTrials.gov Identifier:
NCT01877135
First received: June 11, 2013
Last updated: September 13, 2013
Last verified: September 2013
  Purpose

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
Anal AIN3
Anal Carcinoma

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Malignant Progression of Anal Intra-epithelial Neoplasia in a Cohort of Patients

Resource links provided by NLM:


Further study details as provided by French Society of Coloproctology:

Primary Outcome Measures:
  • at least one anal cancer [ Time Frame: 3-year incidence of anal carcinoma ] [ Designated as safety issue: No ]
    the first diagnosis of anal carcinoma


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 1000
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)
Groups/Cohorts
Anal AIN3
patients > 18 years, with anal AIN3, without history of anal carcinoma

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 : 33 (50 physicians) Length of follow-up: 3 years at least Length of study : 3 years of inclusion and 3 years of follow-up at least"

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients consulting a proctologist in primary care or in hospital

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01877135

Contacts
Contact: Laurent Abramowitz, MD 00331 40 25 87 16 laurent.abramowitz@bch.aphp.fr
Contact: Charlotte Bord, MD 00334 67 67 91 78 charlotte.bord@free.fr

Locations
France
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    laurent.abramowitz@bch.aphp.fr   
Contact: Charlotte Bord, MD    0033 6 44 07 07 94    charlotte.bord@free.fr   
Principal Investigator: Laurent Abramowitz, MD         
Sponsors and Collaborators
French Society of Coloproctology
Société Nationale Française de Gastroentérologie
Investigators
Principal Investigator: Laurent Abramowitz, MD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: French Society of Coloproctology
ClinicalTrials.gov Identifier: NCT01877135     History of Changes
Other Study ID Numbers: 11-LAZ-001
Study First Received: June 11, 2013
Last Updated: September 13, 2013
Health Authority: France: Ministry of Health

Keywords provided by French Society of Coloproctology:
anal carcinoma
AIN3
cohort study

Additional relevant MeSH terms:
Anus Neoplasms
Carcinoma
Carcinoma in Situ
Anus Diseases
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Rectal Diseases
Rectal Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014