Clinical trial NCT05058846: Pilot Study of Pancreatic Cancer Screening
Official title: Pilot Study of Pancreatic Cancer Screening
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Carcinoma
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2021-09-28
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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.

Detailed description: 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.

EXPLORATORY OBJECTIVES:

I. 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.

II. 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: GROUP I: Participants may opt to undergo MRI/magnetic resonance cholangiopancreatography (MRCP) or alternating MRI/MRCP and EUS annually for 10 years or complete questionnaires over 10 minutes and undergo blood, saliva and tissue sample collection.

GROUP II: Participants may undergo MRI/MRCP or alternating MRI/MRCP and EUS annually for 10 years.

Eligibility criteria: Inclusion Criteria:

Ability to provide consent and willing, and able to comply with study procedures Ability to read and speak English

GROUP I:

* 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.

GROUP II:

* 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)

Exclusion Criteria:

* Prior or active pancreatic cancer.
* Pregnant women are excluded from this study because effects of an MRI on developing fetus is unknown.

Primary outcomes:
measure: Proportion of participants with of abnormal magnetic resonance imaging (MRI) findings
timeFrame: Up to 10 years
Secondary outcomes:
measure: Overall Cancer Detection Rate
timeFrame: Up to 10 years
measure: Rates of high-grade neoplastic precursors
timeFrame: Up to 10 years
measure: Rates of pancreatic ductal adenocarcinoma (PDAC)
timeFrame: Up to 10 years
measure: Proportion of participants who have additional medical procedures
timeFrame: Up to 10 years
Other outcomes:
measure: Scores on the Pancreatic Cancer Knowledge Survey
timeFrame: Baseline, approximately 1 day
measure: Change in scores on the Pancreatic Cancer Worry Scale
timeFrame: Up to 10 years
measure: Change in scores on the Disease Specified Perceived Risk Survey
timeFrame: Up to 10 years
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Pamela N Munster, MD
role: PRINCIPAL_INVESTIGATOR
References: