Pilot Study of Pancreatic Cancer Screening
ConditionPancreatic Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Prior or active pancreatic cancer.
Pregnant women are excluded from this study because effects of an MRI on developing fetus is unknown.
Trial population
Adults with germline BRCA, ATM or PALB2 mutation with or without a strong family history of pancreatic cancer. Eligible participants will be identified through UCSF's Hereditary Cancer Clinic or referred through UCSF's gastroenterology clinics.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo blood, tissue, and saliva collection
Magnetic Resonance Cholangiopancreatography
Procedure/SurgeryUndergo MRCP
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Endoscopic ultrasound
Procedure/SurgeryUndergo endoscopic ultrasound
Questionnaires
Other interventionComplete the following questionnaires: Pancreatic Cancer Knowledge Survey, Pancreatic Cancer Worry Scale, Disease Specific Perceived Risk Survey, eGene Questionnaire
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Group I: No strong family history of pancreatic cancer5 interventions
Group B: Group II: Strong family history of pancreatic cancer5 interventions
Trial outcomes
Primary outcomes
1
Proportion of participants with of abnormal magnetic resonance imaging (MRI) findings
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.
Time frame
Up to 10 yearsSecondary outcomes
1
Overall Cancer Detection Rate
Will estimate and infer 95% binomial confidence intervals (CI) and the overall cancer detection rate for all participants on study.
Time frame
Up to 10 years2
Rates of high-grade neoplastic precursors
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.
Time frame
Up to 10 years3
Rates of pancreatic ductal adenocarcinoma (PDAC)
Will estimate and infer 95% binomial CI and the overall rate of PDAC for all participants on study.
Time frame
Up to 10 years4
Proportion of participants who have additional medical procedures
The proportion of participants who have obtained a biopsy or underwent a surgical procedure related to a possible diagnosis of cancer will be reported.
Time frame
Up to 10 yearsOther outcomes
1
Scores on the Pancreatic Cancer Knowledge Survey
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.
Time frame
Baseline, approximately 1 day2
Change in scores on the Pancreatic Cancer Worry Scale
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.
Time frame
Up to 10 years3
Change in scores on the Disease Specified Perceived Risk Survey
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.
Time frame
Up to 10 yearsSponsors and contacts
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Source ClinicalTrials.gov