Clinical trial NCT01877135: Malignant Progression of Anal Intra-epithelial Neoplasia in a Cohort of Patients
Official title: Malignant Progression of Anal Intra-epithelial Neoplasia in a Cohort of Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anal AIN3
Anal Carcinoma
Keywords: anal carcinoma
AIN3
cohort study
Lead sponsor: French Society of Coloproctology
Sponsor class: OTHER
Collaborators: name: Société Nationale Française de Gastroentérologie
First posted: 2013-06-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients consulting a proctologist in primary care or in hospital

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"

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

Primary outcomes:
measure: at least one anal cancer
timeFrame: 3-year incidence of anal carcinoma
Secondary outcomes:
measure: Observance
timeFrame: 3 years
measure: patient's feelings about his therapeutic care and impact on his emotional life
timeFrame: 3 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Service d'Hépato-gastro-entérologie, Hôpital Bichat, 46 rue Henri Huchard
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Laurent Abramowitz, MD
role: PRINCIPAL_INVESTIGATOR
References: