Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Mallika Dhawan
Photo of Mallika Dhawan
Mallika Dhawan

Description

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.

Details

PRIMARY OBJECTIVE: I. To determine the event rate of abnormal magnetic resonance imaging (MRI) 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: 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.

Keywords

Pancreatic Carcinoma Pancreatic Neoplasms Biospecimen Collection Magnetic Resonance Cholangiopancreatography Magnetic Resonance Imaging Endoscopic ultrasound

Eligibility

You can join if…

Open to people ages 18 years and up

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 CAN'T join if...

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

Location

  • University of California San Francisco
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Mallika Dhawan
    Assistant Professor, Medicine. Authored (or co-authored) 15 research publications.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05058846
Study Type
Observational
Last Updated