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Pilot Study of Pancreatic Cancer Screening

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ClinicalTrials.gov Identifier: NCT05058846
Recruitment Status : Recruiting
First Posted : September 28, 2021
Last Update Posted : April 14, 2022
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Pancreatic Carcinoma Procedure: Biospecimen Collection Procedure: Magnetic Resonance Cholangiopancreatography Procedure: Magnetic Resonance Imaging Procedure: Endoscopic ultrasound Other: Questionnaires

Detailed 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.

Study Design
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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study of Pancreatic Cancer Screening
Actual Study Start Date : January 20, 2022
Estimated Primary Completion Date : January 31, 2032
Estimated Study Completion Date : January 31, 2032

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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) 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
Undergo blood, tissue, and saliva collection
Other Name: Biological Sample Collection

Procedure: Magnetic Resonance Cholangiopancreatography
Undergo MRCP
Other Name: MRCP

Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • Magnetic Resonance Imaging Scan
  • MR Imaging
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging

Other: Questionnaires
Complete the following questionnaires: Pancreatic Cancer Knowledge Survey, Pancreatic Cancer Worry Scale, Disease Specific Perceived Risk Survey, eGene Questionnaire
Other Name: Surveys
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
Undergo blood, tissue, and saliva collection
Other Name: Biological Sample Collection

Procedure: Magnetic Resonance Cholangiopancreatography
Undergo MRCP
Other Name: MRCP

Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • Magnetic Resonance Imaging Scan
  • MR Imaging
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging

Procedure: Endoscopic ultrasound
Undergo endoscopic ultrasound
Other Name: EUS

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


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of participants with of abnormal magnetic resonance imaging (MRI) findings [ Time Frame: Up to 10 years ]
    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.


Secondary Outcome Measures :
  1. Overall Cancer Detection Rate [ Time Frame: Up to 10 years ]
    Will estimate and infer 95% binomial confidence intervals (CI) and the overall cancer detection rate for all participants on study.

  2. Rates of high-grade neoplastic precursors [ Time Frame: Up to 10 years ]
    Will estimate and infer 95% binomial CI and the overall rate of high-grade pancreatic neoplasia precursors (IPMN-HGD and PanIN-3) for all participants on study.

  3. Rates of pancreatic ductal adenocarcinoma (PDAC) [ Time Frame: Up to 10 years ]
    Will estimate and infer 95% binomial CI and the overall rate of PDAC for all participants on study.

  4. Proportion of participants who have additional medical procedures [ Time Frame: Up to 10 years ]
    The proportion of participants who have obtained a biopsy or underwent a surgical procedure related to a possible diagnosis of cancer will be reported.


Other Outcome Measures:
  1. Scores on the Pancreatic Cancer Knowledge Survey [ Time Frame: Baseline, approximately 1 day ]
    The Pancreatic Cancer Knowledge Survey is a 3-item, multiple choice questionnaire designed to gauge participant knowledge on the risk for pancreatic cancer in patients with inherited cancer risk mutations, specifically pancreatic ductal adenocarcinoma (PDAC) and given to participants at time of enrollment. Scores range from 0 to 3, with a higher score indicating a greater knowledge of general pancreatic cancer information.

  2. Change in scores on the Pancreatic Cancer Worry Scale [ Time Frame: Up to 10 years ]
    The Pancreatic Cancer Worry Scale is a 4-item, multiple choice questionnaire which assesses the participants level of worry about developing or existing pancreatic cancers. Scores for each item range from 1='rarely or never'/'not at all' to 4="All of the time / very concerned" for a total score range of 4-16. Higher scores indicate a greater level of worry.

  3. Change in scores on the Disease Specified Perceived Risk Survey [ Time Frame: Up to 10 years ]
    The Disease Specified Perceived Risk Survey is a 4-item survey which addresses participant's perceived risk of developing cancer. Scores for each item range from 0 to 100, for a total score range of 0-400. Higher scores indicating a greater level of perceived risk.


Biospecimen Retention:   Samples With DNA
Whole blood, tissue, and saliva

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   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.
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05058846


Contacts
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Contact: Phu Lam (415) 353-8337 Phu.Lam@ucsf.edu

Locations
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United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Phu Lam    415-353-8337    Phu.Lam@ucsf.edu   
Contact    877-827-3222    cancertrials@ucsf.edu   
Principal Investigator: Pamela N Munster, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Pamela N Munster, MD University of California, San Francisco
More Information
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05058846    
Other Study ID Numbers: 209514
NCI-2021-07922 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: September 28, 2021    Key Record Dates
Last Update Posted: April 14, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases