Malignant Progression of Anal Intra-epithelial Neoplasia... | NCT01877135

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

NCT01877135

Sponsor

French Society of Coloproctology

Status

Unknown status

Last Update Posted

Mar 5, 2015Estimated

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Anal AIN3
Anal Carcinoma

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Jun 2016Estimated

Completion Date

Jun 2019Estimated

First Submitted Date

Jun 11, 2013

First Submission Date that Met QC Criteria

Jun 12, 2013

First Posted Date

Jun 13, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2015

Last Update Posted Date

Mar 5, 2015Estimated

Name	Class
Société Nationale Française de Gastroentérologie	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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"

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,000Estimated

Label	Type	Description	Intervention Names
Anal AIN3		patients > 18 years, with anal AIN3, without history of anal carcinoma

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
at least one anal cancer	the first diagnosis of anal carcinoma	3-year incidence of anal carcinoma

Secondary Outcomes

Measure	Description	Time Frame
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
patient's feelings about his therapeutic care and impact on his emotional life

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients consulting a proctologist in primary care or in hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
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

Overall Officials

Name	Affiliation	Role
Laurent Abramowitz, MD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service d'Hépato-gastro-entérologie, Hôpital Bichat, 46 rue Henri Huchard	Recruiting	Paris	Paris	75018	France

ID	Term
D012004	Rectal Neoplasms
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms