Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016029
Status:
TERMINATED
Last Update Posted:
2013-03-22
First Post:
2001-05-06
Brief Title:
Comparison of Barium Enema Computed Tomographic Colonography and Colonoscopy in Detecting Colon Cancer
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Prospective Comparison of Air Contrast Barium Enema ACBE Computed Tomographic Colonography Virtual Colonoscopy and Colonoscopy for Evaluation of the Colon in Patients With Fecal Occult Blood
Status:
TERMINATED
Status Verified Date:
2003-09
Last Known Status:
None
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:
None
Brief Summary:
RATIONALE Screening tests may help doctors detect cancer cells early and plan more effective treatment for cancer New diagnostic procedures such as computed tomographic colonography may provide a less invasive method of identifying patients who have colon cancer
PURPOSE Diagnostic and screening trial to compare the effectiveness of barium enema computed tomographic colonography and colonoscopy in detecting of colon cancer
PURPOSE Diagnostic and screening trial to compare the effectiveness of barium enema computed tomographic colonography and colonoscopy in detecting of colon cancer
Detailed Description:
OBJECTIVES
Compare the accuracy of air contrast barium enema computed tomographic colonography virtual colonoscopy and colonoscopy for the detection of colonic lesions in patients with factors related to colon cancer
Compare the patient experience during each of these imaging tests
OUTLINE This is a multicenter study
A repeat fecal occult blood test is performed Patients then undergo an air contrast barium enema ACBE At 7-10 days after ACBE patients undergo a computed tomographic colonography virtual colonoscopy followed by a colonoscopy on the same day
A repeat ACBE may be performed if there is a discrepancy between the initial ACBE and colonoscopy If the repeat ACBE continues to show an abnormality patients undergo a second colonoscopy
Within 24 hours of completion of each test patients fill out a questionnaire about their experience At 5-7 days after completion of all tests patients complete a final questionnaire comparing all 3 tests
PROJECTED ACCRUAL A total of 2133 patients will be accrued for this study within 4 years
Compare the accuracy of air contrast barium enema computed tomographic colonography virtual colonoscopy and colonoscopy for the detection of colonic lesions in patients with factors related to colon cancer
Compare the patient experience during each of these imaging tests
OUTLINE This is a multicenter study
A repeat fecal occult blood test is performed Patients then undergo an air contrast barium enema ACBE At 7-10 days after ACBE patients undergo a computed tomographic colonography virtual colonoscopy followed by a colonoscopy on the same day
A repeat ACBE may be performed if there is a discrepancy between the initial ACBE and colonoscopy If the repeat ACBE continues to show an abnormality patients undergo a second colonoscopy
Within 24 hours of completion of each test patients fill out a questionnaire about their experience At 5-7 days after completion of all tests patients complete a final questionnaire comparing all 3 tests
PROJECTED ACCRUAL A total of 2133 patients will be accrued for this study within 4 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000068587 | OTHER | NCI | None |
| DUMC-000866-00-5R | None | None | None |
| DUMC-CA14326 | None | None | None |
| NCI-V01-1655 | None | None | None |