Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087360
Status:
COMPLETED
Last Update Posted:
2013-07-11
First Post:
2004-07-08
Brief Title:
Genetic and Environmental Risk Assessment for Colorectal Cancer in Healthy Participants
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Providing Genetic And Environmental Cancer Risk Assessment In Primary Care
Status:
COMPLETED
Status Verified Date:
2013-07
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 Evaluating the knowledge and attitudes of healthy participants toward a new diet and gene test for colorectal cancer risk may help doctors improve acceptance of colorectal cancer screening
PURPOSE This clinical trial is studying the knowledge and attitudes of healthy participants toward genetic and environmental risk assessment for colorectal cancer
PURPOSE This clinical trial is studying the knowledge and attitudes of healthy participants toward genetic and environmental risk assessment for colorectal cancer
Detailed Description:
OBJECTIVES
Part 1
Determine the willingness of healthy participants to enroll in a genetic and environmental risk assessment for colorectal cancer
Determine the impact of decision counseling on knowledge and attitudes about genetic and environmental risk assessment GERA and colorectal cancer screening in these participants
Determine participants understanding of GERA
Determine participants response to GERA results
Part 2
Determine awareness of and interest in diet and genetic assessment for colorectal cancer among healthy participants at average risk for colorectal cancer who have not undergone regular colon cancer screening
Determine participants level of knowledge of this assessment
Determine participants rate of acceptance into this study
OUTLINE This is a 2-part pilot study
Part 1 Participants complete a baseline questionnaire on attitudes beliefs and knowledge about colorectal cancer CRC CRC screening and diet and genetic testing for colorectal cancer risk Two-four weeks later participants are educated about CRC screening options and undergo genetic and environmental risk assessment GERA decision counseling about the methylene tetrahydrofolate reductase MTHFR gene and dietary folate intake Participants who decide to undergo GERA undergo blood testing for MTHFR polymorphisms and folate levels Participants whose blood tests indicate low folate levels are further counseled about dietary folate intake
Part 2 Participants complete a questionnaire on attitudes beliefs and knowledge about CRC CRC screening and diet and genetic testing for colorectal cancer risk
Participants in part 1 are followed at 1 week 1 month and then at 6 months
PROJECTED ACCRUAL A total of 110 participants 60 for part 1 and 50 for part 2 will be accrued for this study
Part 1
Determine the willingness of healthy participants to enroll in a genetic and environmental risk assessment for colorectal cancer
Determine the impact of decision counseling on knowledge and attitudes about genetic and environmental risk assessment GERA and colorectal cancer screening in these participants
Determine participants understanding of GERA
Determine participants response to GERA results
Part 2
Determine awareness of and interest in diet and genetic assessment for colorectal cancer among healthy participants at average risk for colorectal cancer who have not undergone regular colon cancer screening
Determine participants level of knowledge of this assessment
Determine participants rate of acceptance into this study
OUTLINE This is a 2-part pilot study
Part 1 Participants complete a baseline questionnaire on attitudes beliefs and knowledge about colorectal cancer CRC CRC screening and diet and genetic testing for colorectal cancer risk Two-four weeks later participants are educated about CRC screening options and undergo genetic and environmental risk assessment GERA decision counseling about the methylene tetrahydrofolate reductase MTHFR gene and dietary folate intake Participants who decide to undergo GERA undergo blood testing for MTHFR polymorphisms and folate levels Participants whose blood tests indicate low folate levels are further counseled about dietary folate intake
Part 2 Participants complete a questionnaire on attitudes beliefs and knowledge about CRC CRC screening and diet and genetic testing for colorectal cancer risk
Participants in part 1 are followed at 1 week 1 month and then at 6 months
PROJECTED ACCRUAL A total of 110 participants 60 for part 1 and 50 for part 2 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 |
|---|---|---|---|
| CDR0000374972 | REGISTRY | PDQ Physician Data Query | None |