Prospective Screening For Pancreatic Ductal Adenocarcinoma In High-Risk Individuals

Study Overview

Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals

The purpose of this research is to see if adding blood-based tests and symptom review to standard-of-care pancreatic cancer screening procedures can identify cancer early among individuals with increased risk.

In this research study, investigators will combine blood-based tests and review of symptoms with standard-of-care pancreatic cancer screening procedures to see if pancreatic cancer can be detected early among individuals with increased risk. Pancreatic cancer screening procedures include Endoscopic Ultrasound (EUS), Magnetic Resonance Imaging (MRI), or Magnetic Resonance Cholangiopancreatography (MRCP). The research study procedures include screening for eligibility, questionnaires, clinic visits, endoscopic ultrasound (EUS) or Magnetic Resonance (MRI)/Magnetic Resonance Cholangiopancreatography (MRCP), and collection of blood, stool, and saliva samples. Participation in this research study will be a minimum of 30 months and up to 20 years via review of medical records and the annual collection of blood and stool samples. It is expected that about 5,000 people will take part in this research study. This study is supported by the Hale Family Research Center at Dana-Farber Cancer Institute.

Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma
PDAC
PDAC - Pancreatic Ductal Adenocarcinoma
Pancreatic Neoplasm

OTHER: Screening Blood Tests
DIAGNOSTIC_TEST: Endoscopic Ultrasound
COMBINATION_PRODUCT: Magnetic Resonance Imaging
COMBINATION_PRODUCT: Magnetic Resonance Cholangiopancreatography

23-147

Study Record Dates

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
First Submitted 2023-11-03	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-05-29
First Submitted that Met QC Criteria 2023-11-03	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-06-03
First Posted (ACTUAL) 2023-11-08	Results First Posted N/A	Last Verified 2025-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Screening

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Pancreatic Cancer High-Risk Participants Study procedures will be conducted as follows: * Baseline visit with questionnaires, blood tests, and pancreas screening procedure (EUS or MRI/MRCP). * Pancreas screening procedures (Endoscopic ultrasound (EUS), or Magnetic Resonance (MRI)/Magnetic Reson	OTHER: Screening Blood Tests Carbohydrate antigen (CA) 19-9, and Hemoglobin A1C (HbA1c) per standard-of-care. DIAGNOSTIC_TEST: Endoscopic Ultrasound Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines. COMBINATION_PRODUCT: Magnetic Resonance Imaging Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines. COMBINATION_PRODUCT: Magnetic Resonance Cholangiopancreatography Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Pancreatic Cancer High-Risk Participants

Study procedures will be conducted as follows: * Baseline visit with questionnaires, blood tests, and pancreas screening procedure (EUS or MRI/MRCP). * Pancreas screening procedures (Endoscopic ultrasound (EUS), or Magnetic Resonance (MRI)/Magnetic Reson

OTHER: Screening Blood Tests

Carbohydrate antigen (CA) 19-9, and Hemoglobin A1C (HbA1c) per standard-of-care.

DIAGNOSTIC_TEST: Endoscopic Ultrasound

Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.

COMBINATION_PRODUCT: Magnetic Resonance Imaging

Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.

COMBINATION_PRODUCT: Magnetic Resonance Cholangiopancreatography

Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.

Primary Outcome Measures	Measure Description	Time Frame
Number of Incident Pancreatic Cancers or High-Grade Pancreatic Neoplasms	Subjects will be counted in this metric if they have pathological tissue confirmation of a pancreatic cancer or high-grade dysplasia during each observation period.	6-monthly for 3 years with 5-year follow-up
Number of Imaging-Positive Pancreatic Cancers or High-Grade Neoplasms	Subjects will be considered imaging-positive if they have a biopsy-confirmed pancreatic ductal adenocarcinoma or high-grade dysplasia that was initially detected on standard-of-care screening MRI or EUS during each observation period.	6-monthly for 3 years with 5-year follow-up
Number of Imaging-Negative, Assay-Positive Pancreatic Cancers or High-Grade Neoplasms	Subjects will be considered imaging-negative and assay-positive if: 1) the subject has a study visit that yields any newly positive CA19-9 (>35U/mL or >=20% increase) or diabetes (FBG >100mg/dL for first time or HgbA1c increased by 0.5) assay result or ENDPAC score >=3 with negative MRI and/or EUS at that visit or within six months prior to that visit; and 2) has a biopsy-confirmed pancreatic ductal adenocarcinoma or high-grade dysplasia within two years after that visit.	6-monthly for 3 years with 5-year follow-up

Secondary Outcome Measures	Measure Description	Time Frame
Positive Predictive Value of Blood Assays	Positive predictive value of blood assays, defined as newly positive CA19-9 (>35U/mL or >=20% increase) or diabetes (FBG >100mg/dL for first time or HgbA1c increased by 0.5) assay result or ENDPAC score >=3, with a positive biopsy for PDAC or High-Grade Dysplasia within six months divided by the total number with a positive blood assay.	6-monthly for 3 years
Negative Predictive Value of Blood Assays	Negative predictive value of blood assays, defined as CA19-9 (<=35U/mL or <20% increase) or diabetes (FBG <100mg/dL for first time or HgbA1c increased by less than 0.5) assay result or ENDPAC score <3, without a positive biopsy for PDAC or High-Grade Dysplasia within six months divided by the total number with a negative blood assay.	6-monthly for 3 years
Proportion of Screen-Detected, Resected Pancreatic Lesions	Number of screen-detected pancreatic lesions that are resected compared to the total number of screen-detected pancreatic lesions.	6-monthly for 3 years
Proportion of Non-Worrisome Pancreatic Lesions	Number of pancreatic lesions that are biopsied without cancer or high-grade dysplasia divided by number of pancreatic lesions that are biopsied.	6-monthly for 3 years
Incremental Yield of Blood-Based Assays over Standard-of-Care Screening	Number of imaging-negative, assay-positive cases showing cancer or high-grade dysplasia divided by the total number of imaging-negative cases with cancer or high-grade dysplasia.	6-monthly for 3 years
Number of False-Positive Assay Results	Number of positive assay results, defined as newly positive CA19-9 (>35U/mL or >=20% increase) or diabetes (FBG >100mg/dL for first time or HgbA1c increased by 0.5) assay result or ENDPAC score >=3, without a clinical diagnosis of pancreatic cancer within one year.	6-monthly for 3 years
Number of Non-PDAC Cancer Diagnoses	Number of non-PDAC cancer detected through blood-based assays, EUS and/or MRI during the active screening period.	6-monthly for 3 years
Clinical Predictors of Neoplastic Development	Frequencies of clinical predictors of neoplastic development as indicated by responses to the study surveys.	up to 8 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Matthew Yurgelun, MD

Phone Number: 617-582-8673

Email: matthew_yurgelun@dfci.harvard.edu

Participation Criteria

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

Individuals with pathogenic/likely pathogenic germline variants in STK11, and age ≥30 years.
Individuals with pathogenic/likely pathogenic germline variants in CDKN2A, and age ≥40 years (or 10 years younger than the earliest exocrine pancreatic cancer diagnosis in the family, whichever is earlier).
Individuals with pathogenic/likely pathogenic germline variants in one of the other pancreatic cancer susceptibility genes (ATM, BRCA1, BRCA2, MLH1, MSH2, MSH6, EPCAM, PALB2, TP53), and age ≥50 years (or 10 years younger than the earliest exocrine pancreatic cancer diagnosis in the family, whichever is earlier) AND

Individuals with pathogenic/likely pathogenic variants in PRSS1 AND a clinical phenotype consistent with hereditary pancreatitis, and age ≥40 years (or 20 years after onset of pancreatitis, whichever is earlier).
Individuals with familial pancreatic cancer including:

Family history of exocrine pancreatic cancer in ≥2 first-degree relatives from the same side of the family, even in the absence of a known pathogenic/likely pathogenic germline variant, OR
Family history of exocrine pancreatic cancer in 1 affected first-degree relative and 1 second-degree relative, even in the absence of a known pathogenic/likely pathogenic germline variant, OR
Family history of exocrine pancreatic cancer in ≥3 first- and/or second-degree relatives from the same side of the family, even in the absence of a known pathogenic/likely pathogenic germline variant.
Individuals who are undergoing clinically recommended pancreatic cancer surveillance.

Individuals with active or prior pancreatic ductal adenocarcinoma diagnosis.
Individuals with any active metastatic cancer.
Individuals who are unable to give informed consent.
Individuals who are under the age of 18 (infants, children, teenagers).
Individuals unable to tolerate Magnetic Resonance Imaging/Magnetic Resonance Cholangiopancreatography and Endoscopic Ultrasound.
Pregnant women are unlikely to be undergoing screening procedures and will not be considered eligible but can consent to the study at a later date.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Matthew Yurgelun, MD, Dana-Farber Cancer Institute

Publications

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

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