Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00102011
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2005-01-18
Brief Title:
Colonoscopy or Fecal Occult Blood Test in Screening Healthy Participants for Colorectal Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Colonoscopy Screening Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
00-046
Brief Summary:
RATIONALE Screening tests such as colonoscopy and fecal occult blood test may help doctors find tumor cells early and plan better treatment for colorectal cancer
PURPOSE This randomized phase III trial is studying colonoscopy to see how well it works compared to fecal occult blood test in screening healthy participants for colorectal cancer
PURPOSE This randomized phase III trial is studying colonoscopy to see how well it works compared to fecal occult blood test in screening healthy participants for colorectal cancer
Detailed Description:
OBJECTIVES
Compare the neoplastic outcome of participants at average risk for colorectal cancer who undergo colonoscopy vs annual fecal occult blood tests
Compare the endoscopic and clinical resources required for these screening methods in these participants
Compare the benefit-to-harm ratio in participants undergoing these screening methods
Determine the level of participation of participants undergoing these screening methods
OUTLINE This is a randomized two-part multicenter study
Participants are asked whether they are interested in participating in a randomized controlled trial of colorectal cancer screening
Screening colonoscopy feasibility study I accrual completed as of 12142004 Participants who are interested in participating in a screening trial are randomized to 1 of 2 screening arms
Arm I Participants undergo baseline screening colonoscopy
Arm II Participants receive standard care
Screening colonoscopy feasibility study II Participants who are interested in participating in a screening trial are randomized to 1 of 2 screening arms
Arm I Participants undergo baseline screening colonoscopy Participants are given individualized recommendations for further surveillance based on the results of the colonoscopy
Arm II Participants undergo a baseline fecal occult blood test FOBT Participants are given individualized recommendations for further surveillance based on the results of the FOBT Participants with negative baseline FOBT undergo FOBT annually for up to 4 years in the absence of a positive FOBT
All participants are followed annually for up to 4 years
PROJECTED ACCRUAL A total of 1402 participants 701 per screening arm have been accrued for feasibility study I within 3 years accrual completed as of 12142004 An additional 3550 participants 1775 per screening arm will be accrued for feasibility study II within 5 years
Compare the neoplastic outcome of participants at average risk for colorectal cancer who undergo colonoscopy vs annual fecal occult blood tests
Compare the endoscopic and clinical resources required for these screening methods in these participants
Compare the benefit-to-harm ratio in participants undergoing these screening methods
Determine the level of participation of participants undergoing these screening methods
OUTLINE This is a randomized two-part multicenter study
Participants are asked whether they are interested in participating in a randomized controlled trial of colorectal cancer screening
Screening colonoscopy feasibility study I accrual completed as of 12142004 Participants who are interested in participating in a screening trial are randomized to 1 of 2 screening arms
Arm I Participants undergo baseline screening colonoscopy
Arm II Participants receive standard care
Screening colonoscopy feasibility study II Participants who are interested in participating in a screening trial are randomized to 1 of 2 screening arms
Arm I Participants undergo baseline screening colonoscopy Participants are given individualized recommendations for further surveillance based on the results of the colonoscopy
Arm II Participants undergo a baseline fecal occult blood test FOBT Participants are given individualized recommendations for further surveillance based on the results of the FOBT Participants with negative baseline FOBT undergo FOBT annually for up to 4 years in the absence of a positive FOBT
All participants are followed annually for up to 4 years
PROJECTED ACCRUAL A total of 1402 participants 701 per screening arm have been accrued for feasibility study I within 3 years accrual completed as of 12142004 An additional 3550 participants 1775 per screening arm will be accrued for feasibility study II within 5 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 |
|---|---|---|---|
| UMN-2003NT062 | None | None | None |
| MSKCC-00046A | None | None | None |