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

NCT ID: NCT01877135

Last Updated: 2015-03-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2019-06-30

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.

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"

Conditions

Anal AIN3; Anal Carcinoma

Study Design

• Observational Model Type: COHORT

Study Groups

Anal AIN3

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

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Société Nationale Française de Gastroentérologie

OTHER

Sponsor Role: collaborator

French Society of Coloproctology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurent Abramowitz, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Service d'Hépato-gastro-entérologie, Hôpital Bichat, 46 rue Henri Huchard

Paris, Paris, France

Site Status: RECRUITING

Countries

France

Central Contacts

Laurent Abramowitz, MD

Role: CONTACT

laurent.abramowitz@bch.aphp.fr

00331 40 25 87 16

Charlotte Bord, MD

Role: CONTACT

charlotte.bord@free.fr

00334 67 67 91 78

Facility Contacts

Laurent Abramowitz, MD

Role: primary

laurent.abramowitz@bch.aphp.fr

0033 1 40 25 72 02

Charlotte Bord, MD

Role: backup

charlotte.bord@free.fr

0033 6 44 07 07 94

Other Identifiers

11-LAZ-001

Identifier Type: -

Identifier Source: org_study_id