Menu
Recruiting NCT05058846

Pilot Study of Pancreatic Cancer Screening

— Observational Pancreatic Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biospecimen Collection, Magnetic Resonance Cholangiopancreatography, Magnetic Resonance Imaging, Endoscopic ultrasound.
Who it may be relevant to
Registry conditions: Pancreatic Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure Biospecimen Collection
    Undergo blood, tissue, and saliva collection
  • Procedure Magnetic Resonance Cholangiopancreatography
    Undergo MRCP
  • Procedure Magnetic Resonance Imaging
    Undergo MRI
  • Procedure Endoscopic ultrasound
    Undergo endoscopic ultrasound
  • Other Questionnaires
    Complete the following questionnaires: Pancreatic Cancer Knowledge Survey, Pancreatic Cancer Worry Scale, Disease Specific Perceived Risk Survey, eGene Questionnaire

Primary outcome measures

  • Proportion of participants with of abnormal magnetic resonance imaging (MRI) findings [Time frame: Up to 10 years]
Secondary outcome measures (4)
  • Overall Cancer Detection Rate [Time frame: Up to 10 years]
  • Rates of high-grade neoplastic precursors [Time frame: Up to 10 years]
  • Rates of pancreatic ductal adenocarcinoma (PDAC) [Time frame: Up to 10 years]
  • Proportion of participants who have additional medical procedures [Time frame: Up to 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of California San Francisco — San Francisco

Identifiers

NCT: NCT05058846 · 209514 · NCI-2021-07922

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗