Pilot Study of Pancreatic Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Proportion of participants with of abnormal magnetic resonance imaging (MRI) findings
研究概览
简要总结
This study investigates how often abnormal findings from routine magnetic resonance imaging occur in people with genetic mutations in BReast CAncer gene. (BRCA), ataxia telangiectasia mutated gene (ATM), or PALB2 screened for pancreatic cancer. This study may lead to a greater understanding of cancer and potentially, improvements in cancer screening and treatment.
详细描述
PRIMARY OBJECTIVE:
I. To determine the event rate of abnormal magnetic resonance imaging (MRI) and Endoscopic ultrasound (EUS) findings in screened study participants.
SECONDARY OBJECTIVES:
I. To determine the rates of high-grade pancreatic neoplasia precursors (intraductal papillary mucinous neoplasm (IPMN)-high-grade dysplasia (HGD)) and pancreatic intraepithelial neoplasia-3 [PanIN-3]) and pancreatic ductal adenocarcinoma (PDAC) among all study participants.
II. To understand rates of procedures (biopsies and surgeries) among all study participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to provide consent and willing, and able to comply with study procedures Ability to read and speak English
- •Documentation of pathogenic or likely pathogenic germline BRCA 1 and 2, ATM or PALB2 germline genetic mutation
- •No strong family history of pancreatic cancer (defined as having >= 1 first-degree or second-degree relative with a history of pancreatic cancer)
- •Age >= 50 years old at time of consent.
- •Documentation of pathogenic or likely pathogenic germline BRCA 1 and 2, ATM, or PALB2 germline genetic mutation
- •Has strong family history of pancreatic cancer (defined as having >= 1 first-degree or second-degree relative with a history of pancreatic cancer)
- •Age >= 18 years old at time of consent (screening generally begins 10 years prior to the earliest pancreatic cancer in the family)
排除标准
- •Prior or active pancreatic cancer.
- •Pregnant women are excluded from this study because effects of an MRI on developing fetus is unknown.
研究组 & 干预措施
Group I: No strong family history of pancreatic cancer
Participants in Group 1 consist of BRCA, ATM and PALB2 mutation carriers without a strong family history of pancreatic cancer and can choose to undergo annual magnetic resonance imaging (MRI)/Magnetic resonance cholangiopancreatography (MRCP) and EUS screening, or they may opt out of annual MRI screening. Participants also have the opportunity to co-enroll in the University of California, San Francisco (UCSF) BRCA Center Biorepository for biospecimen/biomarker collection and will complete surveys, including the optional eGene questionnaire, which involves co-enrollment in the eGene Study.
干预措施: Biospecimen Collection (Procedure)
Group I: No strong family history of pancreatic cancer
Participants in Group 1 consist of BRCA, ATM and PALB2 mutation carriers without a strong family history of pancreatic cancer and can choose to undergo annual magnetic resonance imaging (MRI)/Magnetic resonance cholangiopancreatography (MRCP) and EUS screening, or they may opt out of annual MRI screening. Participants also have the opportunity to co-enroll in the University of California, San Francisco (UCSF) BRCA Center Biorepository for biospecimen/biomarker collection and will complete surveys, including the optional eGene questionnaire, which involves co-enrollment in the eGene Study.
干预措施: Magnetic Resonance Cholangiopancreatography (Procedure)
Group I: No strong family history of pancreatic cancer
Participants in Group 1 consist of BRCA, ATM and PALB2 mutation carriers without a strong family history of pancreatic cancer and can choose to undergo annual magnetic resonance imaging (MRI)/Magnetic resonance cholangiopancreatography (MRCP) and EUS screening, or they may opt out of annual MRI screening. Participants also have the opportunity to co-enroll in the University of California, San Francisco (UCSF) BRCA Center Biorepository for biospecimen/biomarker collection and will complete surveys, including the optional eGene questionnaire, which involves co-enrollment in the eGene Study.
干预措施: Magnetic Resonance Imaging (Procedure)
Group I: No strong family history of pancreatic cancer
Participants in Group 1 consist of BRCA, ATM and PALB2 mutation carriers without a strong family history of pancreatic cancer and can choose to undergo annual magnetic resonance imaging (MRI)/Magnetic resonance cholangiopancreatography (MRCP) and EUS screening, or they may opt out of annual MRI screening. Participants also have the opportunity to co-enroll in the University of California, San Francisco (UCSF) BRCA Center Biorepository for biospecimen/biomarker collection and will complete surveys, including the optional eGene questionnaire, which involves co-enrollment in the eGene Study.
干预措施: Endoscopic ultrasound (Procedure)
Group I: No strong family history of pancreatic cancer
Participants in Group 1 consist of BRCA, ATM and PALB2 mutation carriers without a strong family history of pancreatic cancer and can choose to undergo annual magnetic resonance imaging (MRI)/Magnetic resonance cholangiopancreatography (MRCP) and EUS screening, or they may opt out of annual MRI screening. Participants also have the opportunity to co-enroll in the University of California, San Francisco (UCSF) BRCA Center Biorepository for biospecimen/biomarker collection and will complete surveys, including the optional eGene questionnaire, which involves co-enrollment in the eGene Study.
干预措施: Questionnaires (Other)
Group II: Strong family history of pancreatic cancer
Participants in Group 2 consist of BRCA, ATM and PALB2 mutation carriers with a strong family history of pancreatic cancer. Participants may undergo annual MRI/MRCP screening and may also elect to get an endoscopic ultrasound (EUS) every other year. Participants also have the opportunity to co-enroll in the UCSF BRCA Center Biorepository for biospecimen/biomarker collection and will complete surveys, including the optional eGene questionnaire, which involves co-enrollment in the eGene Study.
干预措施: Biospecimen Collection (Procedure)
Group II: Strong family history of pancreatic cancer
Participants in Group 2 consist of BRCA, ATM and PALB2 mutation carriers with a strong family history of pancreatic cancer. Participants may undergo annual MRI/MRCP screening and may also elect to get an endoscopic ultrasound (EUS) every other year. Participants also have the opportunity to co-enroll in the UCSF BRCA Center Biorepository for biospecimen/biomarker collection and will complete surveys, including the optional eGene questionnaire, which involves co-enrollment in the eGene Study.
干预措施: Magnetic Resonance Cholangiopancreatography (Procedure)
Group II: Strong family history of pancreatic cancer
Participants in Group 2 consist of BRCA, ATM and PALB2 mutation carriers with a strong family history of pancreatic cancer. Participants may undergo annual MRI/MRCP screening and may also elect to get an endoscopic ultrasound (EUS) every other year. Participants also have the opportunity to co-enroll in the UCSF BRCA Center Biorepository for biospecimen/biomarker collection and will complete surveys, including the optional eGene questionnaire, which involves co-enrollment in the eGene Study.
干预措施: Magnetic Resonance Imaging (Procedure)
Group II: Strong family history of pancreatic cancer
Participants in Group 2 consist of BRCA, ATM and PALB2 mutation carriers with a strong family history of pancreatic cancer. Participants may undergo annual MRI/MRCP screening and may also elect to get an endoscopic ultrasound (EUS) every other year. Participants also have the opportunity to co-enroll in the UCSF BRCA Center Biorepository for biospecimen/biomarker collection and will complete surveys, including the optional eGene questionnaire, which involves co-enrollment in the eGene Study.
干预措施: Endoscopic ultrasound (Procedure)
Group II: Strong family history of pancreatic cancer
Participants in Group 2 consist of BRCA, ATM and PALB2 mutation carriers with a strong family history of pancreatic cancer. Participants may undergo annual MRI/MRCP screening and may also elect to get an endoscopic ultrasound (EUS) every other year. Participants also have the opportunity to co-enroll in the UCSF BRCA Center Biorepository for biospecimen/biomarker collection and will complete surveys, including the optional eGene questionnaire, which involves co-enrollment in the eGene Study.
干预措施: Questionnaires (Other)
结局指标
主要结局
Proportion of participants with of abnormal magnetic resonance imaging (MRI) findings
时间窗: Up to 10 years
Proportion of participants with an abnormal MRI finding will be reported as an event. An estimated event rate of 19% in participants with a strong family history (FH) of pancreatic cancer and 10% in those participants without a strong FH of pancreatic cancer and 95% binomial confidence intervals (CIs) will also be reported.
次要结局
- Overall Cancer Detection Rate(Up to 10 years)
- Proportion of participants who have additional medical procedures(Up to 10 years)
- Rates of pancreatic ductal adenocarcinoma (PDAC)(Up to 10 years)
- Rates of high-grade neoplastic precursors(Up to 10 years)