Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004210
Status:
COMPLETED
Last Update Posted:
2014-10-24
First Post:
2000-01-21
Brief Title:
Study of the Results of Education and Counseling for Persons Undergoing Genetic Testing for Hereditary Nonpolyposis Colon Cancer
Sponsor:
National Human Genome Research Institute NHGRI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Outcomes in Education and Counseling for HNPCC Testing
Status:
COMPLETED
Status Verified Date:
2009-07
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 Identifying family and individual characteristics may help plan education and counseling for patients who are considering genetic testing
PURPOSE This clinical trial is studying education and counseling to see what effect they have in patients who are undergoing genetic testing for hereditary nonpolyposis colon cancer recruitment of new families with HNPCC stopped as of 04-26-06 recruitment of persons within families already participating continues
PURPOSE This clinical trial is studying education and counseling to see what effect they have in patients who are undergoing genetic testing for hereditary nonpolyposis colon cancer recruitment of new families with HNPCC stopped as of 04-26-06 recruitment of persons within families already participating continues
Detailed Description:
OBJECTIVES
Identify family characteristics personality traits and religious and spiritual beliefs that significantly affect individual decisions regarding mutation testing for hereditary nonpolyposis colon cancer HNPCC recruitment of new families with HNPCC stopped as of 04-26-06 recruitment of persons within families already participating continues
Determine the impact of negative vs positive mutation test results on family relationships and psychological status
Assess expectations regarding testing and how they influence perceptions of risks and responses to risk notification
Determine the impact of risk notification on the frequency of screeningprevention activities
Formulate a standard diagnostic algorithm for determining microsatellite instability based on the analysis of tumors with this extensive array of markers and correlate specific replication error phenotypes with germline genotype
OUTLINE Participants complete a baseline assessment of knowledge risk perception and personality traits followed by a structured pretest education session Participants are then offered the choice of whether or not to undergo genetic testing for mutations in hereditary nonpolyposis colon cancer HNPCC genes Participants who choose to undergo genetic testing provide a blood sample for this purpose Participants who undergo genetic testing receive results and counseling recruitment of new families with HNPCC stopped as of 04-26-06 recruitment of persons within families already participating continues
Available surveillance options are discussed for all participants Psychological and behavioral outcomes are reassessed at 6 and 12 months for both those choosing and not choosing genetic testing
Tumors when available are analyzed for mismatched repair deficiency on the basis of microsatellite instability
PROJECTED ACCRUAL A total of 900 participants will be accrued for this study with a specific target of 200 individuals who have not experienced cancer within families identified with hereditary nonpolyposis colon cancer HNPCC mutations recruitment of new families with HNPCC stopped as of 04-26-06 recruitment of persons within families already participating continues
Identify family characteristics personality traits and religious and spiritual beliefs that significantly affect individual decisions regarding mutation testing for hereditary nonpolyposis colon cancer HNPCC recruitment of new families with HNPCC stopped as of 04-26-06 recruitment of persons within families already participating continues
Determine the impact of negative vs positive mutation test results on family relationships and psychological status
Assess expectations regarding testing and how they influence perceptions of risks and responses to risk notification
Determine the impact of risk notification on the frequency of screeningprevention activities
Formulate a standard diagnostic algorithm for determining microsatellite instability based on the analysis of tumors with this extensive array of markers and correlate specific replication error phenotypes with germline genotype
OUTLINE Participants complete a baseline assessment of knowledge risk perception and personality traits followed by a structured pretest education session Participants are then offered the choice of whether or not to undergo genetic testing for mutations in hereditary nonpolyposis colon cancer HNPCC genes Participants who choose to undergo genetic testing provide a blood sample for this purpose Participants who undergo genetic testing receive results and counseling recruitment of new families with HNPCC stopped as of 04-26-06 recruitment of persons within families already participating continues
Available surveillance options are discussed for all participants Psychological and behavioral outcomes are reassessed at 6 and 12 months for both those choosing and not choosing genetic testing
Tumors when available are analyzed for mismatched repair deficiency on the basis of microsatellite instability
PROJECTED ACCRUAL A total of 900 participants will be accrued for this study with a specific target of 200 individuals who have not experienced cancer within families identified with hereditary nonpolyposis colon cancer HNPCC mutations recruitment of new families with HNPCC stopped as of 04-26-06 recruitment of persons within families already participating continues
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 |
|---|---|---|---|
| NHGRI-95-HG-0165 | None | None | None |
| NCI-95-HG-0165 | None | None | None |
| NCI-NMOB-9501 | None | None | None |