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| ID | Type | Description | Link |
|---|---|---|---|
| P50CA097186 | U.S. NIH Grant/Contract | View source | |
| NCI-2020-00933 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 8754 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This trial studies the role of inherited (present at birth) mutations in cancer risk genes such as BRCA2, BRCA1, ATM, CHEK2, and others in relation to prostate cancer. This study may help researchers understand the frequency and importance of inherited mutations in cancer risk genes in patients with prostate cancer and potentially help identify better ways to treat cancer in patients who have a mutation in one of these genes.
OUTLINE:
Participants complete questionnaire over 20 minutes at baseline, then undergo collection of saliva sample for genetic testing. Participants identified to have an inherited mutation in a deoxyribonucleic acid (DNA) repair gene undergo genetic counseling. Participants whose genetic testing does not indicate an inherited mutation in a DNA repair gene receive a letter thanking them for their participation and emphasizing the importance of ongoing communication with their physician and family members about cancer risk. Participants may also receive an educational flyer with or without a educational video regarding prostate cancer and genetic testing.
Participants will be sent newsletters every year to encourage study engagement and update health questionnaires every two years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case Ascertainment | Men with prostate cancer |
| |
| Family Recruitment | Male relatives of men with prostate cancer |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Behavioral | Complete questionnaire |
|
| Measure | Description | Time Frame |
|---|---|---|
| Identification of a population-based cohort of men with prostate cancer (PC) and germline deoxyribonucleic acid (DNA) repair gene (gDRG) mutations | Identification to be determined through the Washington State Cancer Registry and by genetic testing on saliva samples for inherited mutations in cancer risk genes such as BRCA2, BRCA1, ATM, and others in prostate cancer. | From the start of study through death (up to 20 years) |
| Clinical, pathologic, and molecular predictors of gDRG mutation carriers for men with PC | Predictors to be identified by analyzing information provided by participants on their health history and potentially further testing or chart review on participants who consent to future contact. | From the start of study through death (up to 20 years) |
| Utility and feasibility of cascade genetic testing through use of family history of men with PC identified to have gDRG mutations | To be determined by collection of information about participants' family history and subsequent analysis of cascade genetic testing outcomes. | From the start of study through death (up to 20 years) |
| Identification of a cohort of men with gDRG mutations without PC | Identification to be determined through family history of men with PC identified through the Washington State Cancer Registry and by genetic testing on saliva samples for inherited mutations in cancer risk genes such as BRCA2, BRCA1, ATM, and others in prostate cancer. | From the start of study through death (up to 20 years) |
| Effectiveness of a germline genetic testing education video: Number of participants who participate in genetic testing after watching germline genetic testing video | Up to 6 months |
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Inclusion Criteria: Case Ascertainment [Cancer Surveillance System (CSS)/Washington State Cancer Registry (WSCR)]:
Inclusion Criteria: Case Ascertainment [UW Medical Center (UWMC)/UW Harborview Medical Center (UWHMC)]:
Inclusion Criteria: Family Recruitment
Exclusion Criteria: Case Ascertainment
Exclusion Criteria: Family Recruitment
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Patients living in Washington State with a new diagnosis of prostate cancer and first degree relatives of patients with prostate cancer
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| Name | Affiliation | Role |
|---|---|---|
| Burcu Darst | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Heather H Cheng | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Daniel W Lin | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Colin C Pritchard | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D013048 | Specimen Handling |
| D005820 | Genetic Testing |
| D005817 | Genetic Counseling |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Biospecimen Collection | Procedure | Provide saliva samples |
|
|
| Genetic Testing | Diagnostic Test | Undergo genetic testing |
|
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| Genetic Counseling | Other | Undergo counseling |
|
| Laboratory Biomarker Analysis | Other | Correlative Studies |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D005821 | Genetic Techniques |
| D033142 | Genetic Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |