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

Anal Carcinoma Clinical Trial

— AIN3  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01877135
• Other study ID #: 11-LAZ-001
• Status: Recruiting
• Phase: N/A
• First received: June 11, 2013
• Last updated: March 4, 2015
• Start date: August 2013
• Est. completion date: June 2019

Study information

• Verified date: September 2013
• Source: French Society of Coloproctology
• Contact: Laurent Abramowitz, MD
• Phone: 00331 40 25 87 16
• Email: laurent.abramowitz[@]bch.aphp.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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"

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 2019
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Anal AIN3
• Anal Carcinoma
• Anus Neoplasms
• Carcinoma in Situ

Locations

Country	Name	City	State
France	Service d'Hépato-gastro-entérologie, Hôpital Bichat, 46 rue Henri Huchard	Paris

Sponsors (2)

Lead Sponsor	Collaborator
French Society of Coloproctology	Société Nationale Française de Gastroentérologie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	at least one anal cancer	the first diagnosis of anal carcinoma	3-year incidence of anal carcinoma	No
Secondary	Observance	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	3 years	No
Secondary	patient's feelings about his therapeutic care and impact on his emotional life	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)	3 years	No