Viewing Study NCT00748449


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Study NCT ID: NCT00748449
Status: None
Last Update Posted: 2011-09-12 00:00:00
First Post: 2008-07-31 00:00:00
Is Possible Gene Therapy: False
Has Adverse Events: False

Brief Title: Colonography Versus Colonoscopy in High Risk Patient
Sponsor: None
Organization:

Study Overview

Official Title: Acceptability and Effectiveness of Colonography Compared to Colonoscopy for the Detection of Advanced Adenomas in Patients at High Risk for Colorectal Cancer
Status: None
Status Verified Date: 2011-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: No more inclusions
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: COLO-TDM
Brief Summary: Secondary objective: to evaluate the medical and economic impact of the implementation of CT- colonography in this setting.Methodology: prospective multicenter randomized controlled trial with direct patient benefitN° of patients to be included: 600 Study follow-up :1 consultation and 3 phone contacts (M1, M6 and M12)Evaluation criteria:Main endpoint: acceptability of the colorectal cancer screening (% of enrolled patients having actually undergone the exploration)Secondary endpoints: - cost/effectiveness ratio of the 2 diagnostic tests with calculation of the economic and medical costs. - number of advanced adenoma detected in each group- number of CRC cases detected in each group
Detailed Description: None

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?: