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2022-01-20
2032-01-31
2032-01-31
250
NCT05058846
University of California, San Francisco
University of California, San Francisco
OBSERVATIONAL
Pilot Study of Pancreatic Cancer Screening
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-09-17 | N/A | 2025-04-30 |
2021-09-17 | N/A | 2025-05-02 |
2021-09-28 | N/A | 2025-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | 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) and EUS scre | PROCEDURE: Biospecimen Collection
PROCEDURE: Magnetic Resonance Cholangiopancreatography
PROCEDURE: Magnetic Resonance Imaging
PROCEDURE: Endoscopic ultrasound
OTHER: Questionnaires
|
| : 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. Parti | PROCEDURE: Biospecimen Collection
PROCEDURE: Magnetic Resonance Cholangiopancreatography
PROCEDURE: Magnetic Resonance Imaging
PROCEDURE: Endoscopic ultrasound
OTHER: Questionnaires
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Phu Lam Phone Number: (415) 353-8337 Email: Phu.Lam@ucsf.edu |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
