Ignite Creation Date:
2024-05-06 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 12:44 PM
Study NCT ID:
NCT03503097
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2018-04-11
Brief Title:
Genetic Testing for Men With Metastatic Prostate Cancer
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
GENTleMEN Genetic Testing for Men With Metastatic Prostate Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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:
GENTleMEN
Brief Summary:
This research study provides genetic testing to men with prostate cancer that has spread to other parts of the body metastatic prostate cancer and will look for inherited genetic mutations in about 30 cancer-risk genes The researchers seek to learn about the participants opinions and concerns about genetic testing to determine if this is an acceptable way to deliver testing and to potentially help guide the participants treatment Neither treatment nor any decisions related to treatment will take place on this study but researchers will share each participants genetic testing results with that participant
Detailed Description:
OUTLINE
Participants receive web-based or hard-copy questionnaires and saliva collection kits via mail or in person Participants also provide saliva samples to be mailed back to Color Genomics for genetic testing once complete Participants then receive phone-based genetic counseling if they are identified to have an inherited mutation in a deoxyribonucleic acid DNA repair gene All participants have access to phone-based genetic counseling whether or not they are not found to have a mutation
After study completion participants are followed up at 6 months
Participants receive web-based or hard-copy questionnaires and saliva collection kits via mail or in person Participants also provide saliva samples to be mailed back to Color Genomics for genetic testing once complete Participants then receive phone-based genetic counseling if they are identified to have an inherited mutation in a deoxyribonucleic acid DNA repair gene All participants have access to phone-based genetic counseling whether or not they are not found to have a mutation
After study completion participants are followed up at 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| NCI-2018-00533 | REGISTRY | None | None |
| 9831 | OTHER | None | None |
| RG1001545 | OTHER | None | None |
| 5P50CA097186-17 | NIH | Fred HutchUniversity of Washington Cancer Consortium | httpsreporternihgovquickSearch5P50CA097186-17 |