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

NCT01877135 | Unknown

• 1 other identifier: 11-LAZ-001
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Anal AIN3; Anal Carcinoma

Keywords

anal carcinoma; AIN3; cohort study

Outcome Measures

Primary Outcomes (1)

• at least one anal cancer

  the first diagnosis of anal carcinoma

  3-year incidence of anal carcinoma

Secondary Outcomes (2)

• Observance

  3 years

• patient's feelings about his therapeutic care and impact on his emotional life

  3 years

Study Arms (1)

Anal AIN3

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients consulting a proctologist in primary care or in hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• French Society of Coloproctology: lead
• Société Nationale Française de Gastroentérologie: collaborator

Study Sites (1)

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

Paris, Paris, 75018, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

A liquid phase anal smear

MeSH Terms

Conditions

Anus Neoplasms

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Study Officials

• Laurent Abramowitz, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurent Abramowitz, MD

CONTACT

00331 40 25 87 16; laurent.abramowitz@bch.aphp.fr

Charlotte Bord, MD

CONTACT

00334 67 67 91 78; charlotte.bord@free.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2013
• First Posted: June 13, 2013
• Study Start: August 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2019
• Last Updated: March 5, 2015

Record last verified: 2013-09

Locations

FR (1)