Pilot Study of Pancreatic Cancer Screening

  • STATUS
    Recruiting
  • End date
    Jan 31, 2032
  • participants needed
    250
  • sponsor
    University of California, San Francisco
Updated on 29 April 2022
endoscopic ultrasound
ATM
palb2
Accepts healthy volunteers

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.

Description

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.

Details
Condition Pancreatic Carcinoma
Treatment magnetic resonance imaging, Questionnaires, biospecimen collection, Endoscopic Ultrasound, Magnetic Resonance Cholangiopancreatography
Clinical Study IdentifierNCT05058846
SponsorUniversity of California, San Francisco
Last Modified on29 April 2022

Eligibility

Yes No Not Sure

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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