Ignite Creation Date:
2024-05-06 @ 1:42 AM
Last Modification Date:
2024-10-26 @ 11:08 AM
Study NCT ID:
NCT01877135
Status:
UNKNOWN
Last Update Posted:
2015-03-05
First Post:
2013-06-11
Brief Title:
Malignant Progression of Anal Intra-epithelial Neoplasia in a Cohort of Patients
Sponsor:
French Society of Coloproctology
Organization:
French Society of Coloproctology
Study Overview
Official Title:
Malignant Progression of Anal Intra-epithelial Neoplasia in a Cohort of Patients
Status:
UNKNOWN
Status Verified Date:
2013-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AIN3
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 wont 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
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 wont 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None