Pilot Study of Pancreatic Cancer Screening
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
PRIMARY OBJECTIVE:
- To determine the event rate of abnormal magnetic resonance imaging (MRI) findings in screened study participants.
SECONDARY OBJECTIVES:
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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.
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To understand rates of procedures (biopsies and surgeries) among all study participants.
EXPLORATORY OBJECTIVES:
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To create a biorepository of all participants through the collection of saliva, blood, and tissue, combined with imaging findings and robust clinical annotation of patient health behaviors in all study participants.
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To explore knowledge, attitudes, and anxiety related to pancreatic cancer screening at annual intervals in all study participants.
OUTLINE: Participants are assigned to 1 of 2 groups.
GROUP I: Participants may opt to undergo MRI/ magnetic resonance cholangiopancreatography (MRCP) annually for 10 years or complete questionnaires over 10 minutes and undergo blood, saliva and tissue sample collection.
GROUP II: Participants undergo MRI/MRCP screening annually for 10 years.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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) 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. |
Procedure: Biospecimen Collection
Undergo blood, tissue, and saliva collection
Other Names:
Procedure: Magnetic Resonance Cholangiopancreatography
Undergo MRCP
Other Names:
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
Other: Questionnaires
Complete the following questionnaires: Pancreatic Cancer Knowledge Survey, Pancreatic Cancer Worry Scale, Disease Specific Perceived Risk Survey, eGene Questionnaire
Other Names:
|
| 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. |
Procedure: Biospecimen Collection
Undergo blood, tissue, and saliva collection
Other Names:
Procedure: Magnetic Resonance Cholangiopancreatography
Undergo MRCP
Other Names:
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
Procedure: Endoscopic ultrasound
Undergo endoscopic ultrasound
Other Names:
Other: Questionnaires
Complete the following questionnaires: Pancreatic Cancer Knowledge Survey, Pancreatic Cancer Worry Scale, Disease Specific Perceived Risk Survey, eGene Questionnaire
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Proportion of participants with of abnormal magnetic resonance imaging (MRI) findings [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.
Secondary Outcome Measures
- Overall Cancer Detection Rate [Up to 10 years]
Will estimate and infer 95% binomial confidence intervals (CI) and the overall cancer detection rate for all participants on study.
- Rates of high-grade neoplastic precursors [Up to 10 years]
Will estimate and infer 95% binomial CI and the overall rate of high-grade pancreatic neoplasia precursors (IPMN-HGD and PanIN-3) for all participants on study.
- Rates of pancreatic ductal adenocarcinoma (PDAC) [Up to 10 years]
Will estimate and infer 95% binomial CI and the overall rate of PDAC for all participants on study.
- Proportion of participants who have additional medical procedures [Up to 10 years]
The proportion of participants who have obtained a biopsy or underwent a surgical procedure related to a possible diagnosis of cancer will be reported.
Other Outcome Measures
- Scores on the Pancreatic Cancer Knowledge Survey [Baseline, approximately 1 day]
The Pancreatic Cancer Knowledge Survey is a 3-item, multiple choice questionnaire designed to gauge participant knowledge on the risk for pancreatic cancer in patients with inherited cancer risk mutations, specifically pancreatic ductal adenocarcinoma (PDAC) and given to participants at time of enrollment. Scores range from 0 to 3, with a higher score indicating a greater knowledge of general pancreatic cancer information.
- Change in scores on the Pancreatic Cancer Worry Scale [Up to 10 years]
The Pancreatic Cancer Worry Scale is a 4-item, multiple choice questionnaire which assesses the participants level of worry about developing or existing pancreatic cancers. Scores for each item range from 1='rarely or never'/'not at all' to 4="All of the time / very concerned" for a total score range of 4-16. Higher scores indicate a greater level of worry.
- Change in scores on the Disease Specified Perceived Risk Survey [Up to 10 years]
The Disease Specified Perceived Risk Survey is a 4-item survey which addresses participant's perceived risk of developing cancer. Scores for each item range from 0 to 100, for a total score range of 0-400. Higher scores indicating a greater level of perceived risk.
Eligibility Criteria
Criteria
Inclusion Criteria:
Ability to provide consent and willing, and able to comply with study procedures Ability to read and speak English
GROUP I:
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Documentation of pathogenic or likely pathogenic germline BRCA 1 and 2, ATM or PALB2 germline genetic mutation
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No strong family history of pancreatic cancer (defined as having >= 1 first-degree or second-degree relative with a history of pancreatic cancer)
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Age >= 50 years old at time of consent.
GROUP II:
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Documentation of pathogenic or likely pathogenic germline BRCA 1 and 2, ATM, or PALB2 germline genetic mutation
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Has strong family history of pancreatic cancer (defined as having >= 1 first-degree or second-degree relative with a history of pancreatic cancer)
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Age >= 18 years old at time of consent (screening generally begins 10 years prior to the earliest pancreatic cancer in the family)
Exclusion Criteria:
Prior or active pancreatic cancer. Pregnant women are excluded from this study because effects of an MRI on developing fetus is unknown.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California San Francisco | San Francisco | California | United States | 94143 |
Sponsors and Collaborators
- University of California, San Francisco
Investigators
- Principal Investigator: Pamela N Munster, MD, University of California, San Francisco
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 209514
- NCI-2021-07922