Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals
1 other identifier
interventional
5,000
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1 pancreatic-cancer
Started Nov 2023
Longer than P75 for early_phase_1 pancreatic-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2023
CompletedFirst Posted
Study publicly available on registry
November 8, 2023
CompletedStudy Start
First participant enrolled
November 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2040
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2041
June 3, 2025
March 1, 2025
17 years
November 3, 2023
May 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (8)
Positive Predictive Value of Blood Assays
6-monthly for 3 years
Negative Predictive Value of Blood Assays
6-monthly for 3 years
Proportion of Screen-Detected, Resected Pancreatic Lesions
6-monthly for 3 years
Proportion of Non-Worrisome Pancreatic Lesions
6-monthly for 3 years
Incremental Yield of Blood-Based Assays over Standard-of-Care Screening
6-monthly for 3 years
- +3 more secondary outcomes
Study Arms (1)
Pancreatic Cancer High-Risk Participants
EXPERIMENTALStudy 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 Resonance Cholangiopancreatography (MRCP), and collection of blood, stool, and saliva samples) every 12 months. * Blood tests and questionnaires every 6 months. * Follow up visits.
Interventions
Carbohydrate antigen (CA) 19-9, and Hemoglobin A1C (HbA1c) per standard-of-care.
Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.
Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.
Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.
Eligibility Criteria
You may qualify if:
- Participants must meet any of the following:
- 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
- Exocrine pancreatic cancer in ≥1 first- or second-degree relative from the same side of (or presumed to be from the same side of) the family as the identified pathogenic/likely pathogenic germline variant.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Brigham and Women's Hospital
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew Yurgelun, MD
Dana-Farber Cancer Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 3, 2023
First Posted
November 8, 2023
Study Start
November 21, 2023
Primary Completion (Estimated)
October 31, 2040
Study Completion (Estimated)
October 31, 2041
Last Updated
June 3, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Matthew Yurgelun, Matthew\_Yurgelun@dfci.harvard.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.