Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025025
Status:
COMPLETED
Last Update Posted:
2016-07-04
First Post:
2001-10-11
Brief Title:
Screening Tests in Detecting Colorectal Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Colorectal Cancer Screening Fecal Blood vs DNA
Status:
COMPLETED
Status Verified Date:
2016-07
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 colorectal cancer
PURPOSE Randomized screening trial to compare the effectiveness of fecal occult blood testing with that of DNA-based testing of stool and blood in identifying colorectal cancer
PURPOSE Randomized screening trial to compare the effectiveness of fecal occult blood testing with that of DNA-based testing of stool and blood in identifying colorectal cancer
Detailed Description:
Primary objectives
1 To compare the performance characteristics sensitivity specificity predictive values of the fecal MTAP and most widely-used fecal occult blood test Hemoccult for identification of screen-relevant colorectal neoplasia curablestage cancer and advanced adenomas with high-grade dysplasiacarcinoma in situ or size 10 cm
2 To evaluate the necessity of formal pretest preparation for MTAP by comparing the specificity of both the MTAP and Hemoccult tests in subject groups randomized to pre-test preparation versus no pre-test preparation
Secondary objectives
1 To compare detection rates of colorectal neoplasia by the fecal MTAP alone with those by flexible sigmoidoscopy distal 60 cm of colonoscopic examination to serve as surrogate and by the combination of sigmoidoscopy plus Hemoccult
2 To characterize and compare the pathological and molecular features of screen-relevant colorectal neoplasms detected and not detected by the fecal MTAP
3 To explore the sensitivity and specificity of the MTAP applied to plasma for the detection of screen-relevant colorectal neoplasia
4 To maintain a specimen bank comprising stools and blood plasma from all subjects and tissue from screen-relevant neoplasms
OUTLINE This is a randomized multicenter study Participants are stratified according to age 50-64 closed to accrual as of 6503 vs 65-80 gender male vs female and participating center Participants are randomized to one of two screening arms
Arm I Participants eat no red meat and take no nonsteroidal anti-inflammatory drugs NSAIDs and no vitamin C or multivitamins for 3 days prior to and during stool sample collection Participants collect stool samples 3 different times and perform fecal occult blood FOB test smears from each stool After each collection participants ship the whole stool and FOB test smear to their participating center for blinded multitarget DNA-based assay panel MTAP testing
Arm II Participants take no vitamin C or multivitamins for 3 days before and during stool sample collection Participants collect stool samples and FOB test smears and samples are tested as in arm I
Within 2 months after stool sample collection participants have their blood drawn for additional MTAP testing and undergo colonoscopy
PROJECTED ACCRUAL A total of 4000 participants 2000 per arm will be accrued for this study
1 To compare the performance characteristics sensitivity specificity predictive values of the fecal MTAP and most widely-used fecal occult blood test Hemoccult for identification of screen-relevant colorectal neoplasia curablestage cancer and advanced adenomas with high-grade dysplasiacarcinoma in situ or size 10 cm
2 To evaluate the necessity of formal pretest preparation for MTAP by comparing the specificity of both the MTAP and Hemoccult tests in subject groups randomized to pre-test preparation versus no pre-test preparation
Secondary objectives
1 To compare detection rates of colorectal neoplasia by the fecal MTAP alone with those by flexible sigmoidoscopy distal 60 cm of colonoscopic examination to serve as surrogate and by the combination of sigmoidoscopy plus Hemoccult
2 To characterize and compare the pathological and molecular features of screen-relevant colorectal neoplasms detected and not detected by the fecal MTAP
3 To explore the sensitivity and specificity of the MTAP applied to plasma for the detection of screen-relevant colorectal neoplasia
4 To maintain a specimen bank comprising stools and blood plasma from all subjects and tissue from screen-relevant neoplasms
OUTLINE This is a randomized multicenter study Participants are stratified according to age 50-64 closed to accrual as of 6503 vs 65-80 gender male vs female and participating center Participants are randomized to one of two screening arms
Arm I Participants eat no red meat and take no nonsteroidal anti-inflammatory drugs NSAIDs and no vitamin C or multivitamins for 3 days prior to and during stool sample collection Participants collect stool samples 3 different times and perform fecal occult blood FOB test smears from each stool After each collection participants ship the whole stool and FOB test smear to their participating center for blinded multitarget DNA-based assay panel MTAP testing
Arm II Participants take no vitamin C or multivitamins for 3 days before and during stool sample collection Participants collect stool samples and FOB test smears and samples are tested as in arm I
Within 2 months after stool sample collection participants have their blood drawn for additional MTAP testing and undergo colonoscopy
PROJECTED ACCRUAL A total of 4000 participants 2000 per arm will be accrued for this study
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 |
|---|---|---|---|
| P30CA015083 | NIH | None | None |
| MAYO-MC9944 | None | None | None |
| NCCTG-MC9944 | None | None | None |
| NCI-P01-0185 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA015083 |