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

18 Years
Not Enrolling
Anal AIN3, Anal Carcinoma

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Trial Information

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

"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

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"

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

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

Type of Study:


Study Design:

Observational Model: Cohort

Outcome Measure:

at least one anal cancer

Outcome Description:

the first diagnosis of anal carcinoma

Outcome Time Frame:

3-year incidence of anal carcinoma

Safety Issue:


Principal Investigator

Laurent Abramowitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris


France: Ministry of Health

Study ID:




Start Date:

June 2013

Completion Date:

June 2019

Related Keywords:

  • Anal AIN3
  • Anal Carcinoma
  • anal carcinoma
  • AIN3
  • cohort study
  • Anus Neoplasms
  • Neoplasms
  • Carcinoma
  • Carcinoma in Situ