Genetic Information to Inform Treatment and Screening for Prostate Cancer, GIFTS Study

Официальное название

Genetic Information to Inform Treatment and Screening (GIFTS) Study for Prostate Cancer

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Questionnaire
  Complete questionnaire
• Процедура Biospecimen Collection
  Provide saliva samples
• Диагностический тест Genetic Testing
  Undergo genetic testing
• Другое Genetic Counseling
  Undergo counseling
• Другое Laboratory Biomarker Analysis
  Correlative Studies

Первичные конечные точки

• Identification of a population-based cohort of men with prostate cancer (PC) and germline deoxyribonucleic acid (DNA) repair gene (gDRG) mutations [Срок оценки: From the start of study through death (up to 20 years)]
• Clinical, pathologic, and molecular predictors of gDRG mutation carriers for men with PC [Срок оценки: 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 [Срок оценки: From the start of study through death (up to 20 years)]
• Identification of a cohort of men with gDRG mutations without PC [Срок оценки: 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 [Срок оценки: Up to 6 months]

Критерии участия

Inclusion Criteria: 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

Exclusion Criteria: 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

США · 1 центр

• Fred Hutch/University of Washington Cancer Consortium — Seattle

Идентификаторы

NCT: NCT04254133 · RG1004177 · P50CA097186 · NCI-2020-00933 · 8754

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗