Pilot Study of Pancreatic Cancer Screening

NCT05058846 | Recruiting

• 2 other identifiers: 209514NCI-2021-07922
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Carcinoma

Outcome Measures

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.

  Up to 10 years

Secondary Outcomes (4)

• Overall Cancer Detection Rate

  Up to 10 years

• Rates of high-grade neoplastic precursors

  Up to 10 years

• Rates of pancreatic ductal adenocarcinoma (PDAC)

  Up to 10 years

• Proportion of participants who have additional medical procedures

  Up to 10 years

Other Outcomes (3)

• Scores on the Pancreatic Cancer Knowledge Survey

  Baseline, approximately 1 day

• Change in scores on the Pancreatic Cancer Worry Scale

  Up to 10 years

• Change in scores on the Disease Specified Perceived Risk Survey

  Up to 10 years

Study Arms (2)

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.

Procedure: Biospecimen Collection; Procedure: Magnetic Resonance Cholangiopancreatography; Procedure: Magnetic Resonance Imaging; Procedure: Endoscopic ultrasound; Other: Questionnaires

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; Procedure: Magnetic Resonance Cholangiopancreatography; Procedure: Magnetic Resonance Imaging; Procedure: Endoscopic ultrasound; Other: Questionnaires

Interventions

Biospecimen Collection PROCEDURE

Undergo blood, tissue, and saliva collection

Also known as: Biological Sample Collection

Group I: No strong family history of pancreatic cancer; Group II: Strong family history of pancreatic cancer

Magnetic Resonance Cholangiopancreatography PROCEDURE

Undergo MRCP

Also known as: MRCP

Group I: No strong family history of pancreatic cancer; Group II: Strong family history of pancreatic cancer

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance Imaging Scan, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Group I: No strong family history of pancreatic cancer; Group II: Strong family history of pancreatic cancer

Endoscopic ultrasound PROCEDURE

Undergo endoscopic ultrasound

Also known as: EUS

Group I: No strong family history of pancreatic cancer; Group II: Strong family history of pancreatic cancer

Questionnaires OTHER

Complete the following questionnaires: Pancreatic Cancer Knowledge Survey, Pancreatic Cancer Worry Scale, Disease Specific Perceived Risk Survey, eGene Questionnaire

Also known as: Surveys

Group I: No strong family history of pancreatic cancer; Group II: Strong family history of pancreatic cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, tissue, and saliva

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy; Endoscopic Ultrasound-Guided Fine Needle Aspiration; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Pamela N Munster, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Phu Lam

CONTACT

(415) 353-8337; Phu.Lam@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: September 28, 2021
• Study Start: January 20, 2022
• Primary Completion (Estimated): January 31, 2032
• Study Completion (Estimated): January 31, 2032
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)