Pilot Study of Pancreatic Cancer Screening

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Pancreatic Carcinoma

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

Study type: Observational

Funder types: Other

Identifiers

NCT05058846

209514

NCI-2021-07922 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

250 participants in 2 patient groups

Group I: No strong family history of pancreatic cancer

Description:

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.

Treatment:

Procedure: Magnetic Resonance Cholangiopancreatography

Procedure: Biospecimen Collection

Other: Questionnaires

Procedure: Magnetic Resonance Imaging

Procedure: Endoscopic ultrasound

Group II: Strong family history of pancreatic cancer

Description:

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.

Treatment:

Procedure: Magnetic Resonance Cholangiopancreatography

Procedure: Biospecimen Collection

Other: Questionnaires

Procedure: Magnetic Resonance Imaging

Procedure: Endoscopic ultrasound