Pilot Study of Pancreatic Cancer Screening

Pancreatic Carcinoma Clinical Trial

Official title:

Pilot Study of Pancreatic Cancer Screening

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05058846
• Other study ID #: 209514
• Secondary ID: NCI-2021-07922
• Status: Recruiting
• Start date: January 20, 2022
• Est. completion date: January 31, 2032

Study information

• Verified date: April 2024
• Source: University of California, San Francisco
• Contact: Phu Lam
• Phone: (415) 353-8337
• Email: Phu.Lam[@]ucsf.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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) 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: January 31, 2032
• Est. primary completion date: January 31, 2032
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Carcinoma
• Pancreatic Neoplasms

Intervention

Procedure:
• Biospecimen Collection
Undergo blood, tissue, and saliva collection
• Magnetic Resonance Cholangiopancreatography
Undergo MRCP
• Magnetic Resonance Imaging
Undergo MRI
• 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

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Scores on the Pancreatic Cancer Knowledge Survey	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.	Baseline, approximately 1 day
Other	Change in scores on the Pancreatic Cancer Worry Scale	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.	Up to 10 years
Other	Change in scores on the Disease Specified Perceived Risk Survey	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.	Up to 10 years
Primary	Proportion of participants with of abnormal magnetic resonance imaging (MRI) findings	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.	Up to 10 years
Secondary	Overall Cancer Detection Rate	Will estimate and infer 95% binomial confidence intervals (CI) and the overall cancer detection rate for all participants on study.	Up to 10 years
Secondary	Rates of high-grade neoplastic precursors	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.	Up to 10 years
Secondary	Rates of pancreatic ductal adenocarcinoma (PDAC)	Will estimate and infer 95% binomial CI and the overall rate of PDAC for all participants on study.	Up to 10 years
Secondary	Proportion of participants who have additional medical procedures	The proportion of participants who have obtained a biopsy or underwent a surgical procedure related to a possible diagnosis of cancer will be reported.	Up to 10 years