Genetic Information to Inform Treatment and Screening (GIFTS) Study for Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,360
- 试验地点
- 1
- 主要终点
- Utility and feasibility of cascade genetic testing through use of family history of men with PC identified to have gDRG mutations
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 35 Years 至 89 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Case Ascertainment [Cancer Surveillance System (CSS)/Washington State Cancer Registry (WSCR)]:
- •Signed informed consent form providing agreement for germline genetic and molecular testing, use release of health and research information; and
- •Male aged 35 to 89 years; and
- •Diagnosis of prostate cancer; and
- •Resident of Washington state at diagnosis; and
- •Willing to complete a questionnaire (online or on paper) to provide basic demographic information, family cancer history, and health history; and
- •Willing and able to provide a saliva sample; and
- •United States (U.S.) mailing address.
- •Inclusion Criteria: Case Ascertainment [UW Medical Center (UWMC)/UW Harborview Medical Center (UWHMC)]:
- •Signed informed consent form providing agreement for germline genetic and molecular testing, use release of health and research information; and
- •Male aged 35 to 89 years; and
- •Diagnosis of prostate cancer; and
- •Self-identifies as Black, African American, or African; and
- •Receiving care at UWMC or UWHMC; and
- •Willing and able to provide a saliva sample; and
- •Able to provide either a U.S. mailing address or Email address or Phone number.
- •Inclusion Criteria: Family Recruitment
- •Signed informed consent form providing agreement for germline genetic and molecular testing, use and release of health and research information; and
- •Males aged 35 to 89 years; and
- •Willingness to complete a questionnaire (online or on paper) to provide basic demographic information, family cancer history, and health history; and
- •Willing and able to provide a saliva sample; and
- •U.S. mailing address
排除标准
- •Case Ascertainment
- •Unable to provide informed consent, e.g., decisional impairment
- •Prior bone marrow transplant
- •Currently under treatment for a hematologic malignancy
- •Study team members
- •Exclusion Criteria: Family Recruitment
- •Unable to provide informed consent, e.g., decisional impairment
- •Prior bone marrow transplant
- •Currently under treatment for a hematologic malignancy
- •Study team members
研究组 & 干预措施
Case Ascertainment
Men with prostate cancer
干预措施: Genetic Testing (Diagnostic Test)
Case Ascertainment
Men with prostate cancer
干预措施: Genetic Counseling (Other)
Case Ascertainment
Men with prostate cancer
干预措施: Laboratory Biomarker Analysis (Other)
Family Recruitment
Male relatives of men with prostate cancer
干预措施: Questionnaire (Behavioral)
Family Recruitment
Male relatives of men with prostate cancer
干预措施: Biospecimen Collection (Procedure)
Family Recruitment
Male relatives of men with prostate cancer
干预措施: Genetic Testing (Diagnostic Test)
Family Recruitment
Male relatives of men with prostate cancer
干预措施: Genetic Counseling (Other)
Family Recruitment
Male relatives of men with prostate cancer
干预措施: Laboratory Biomarker Analysis (Other)
Case Ascertainment
Men with prostate cancer
干预措施: Questionnaire (Behavioral)
Case Ascertainment
Men with prostate cancer
干预措施: Biospecimen Collection (Procedure)
结局指标
主要结局
Utility and feasibility of cascade genetic testing through use of family history of men with PC identified to have gDRG mutations
时间窗: From the start of study through death (up to 20 years)
To be determined by collection of information about participants' family history and subsequent analysis of cascade genetic testing outcomes.
Identification of a population-based cohort of men with prostate cancer (PC) and germline deoxyribonucleic acid (DNA) repair gene (gDRG) mutations
时间窗: From the start of study through death (up to 20 years)
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.
Clinical, pathologic, and molecular predictors of gDRG mutation carriers for men with PC
时间窗: From the start of study through death (up to 20 years)
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.
Identification of a cohort of men with gDRG mutations without PC
时间窗: From the start of study through death (up to 20 years)
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.
Effectiveness of a germline genetic testing education video: Number of participants who participate in genetic testing after watching germline genetic testing video
时间窗: Up to 6 months
Will determine whether patients are more likely to participate in germline genetic testing after viewing an education video about prostate cancer genetic testing.
次要结局
未报告次要终点