Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals

NCT ID: NCT06122896

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 5000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-21
• Study Completion Date: 2041-10-31

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.

Detailed Description

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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 Resonance Cholangiopancreatography (MRCP), and collection of blood, stool, and saliva samples) every 12 months.
• Blood tests and questionnaires every 6 months.
• Follow up visits.

Group Type: EXPERIMENTAL

Screening Blood Tests

Intervention Type: OTHER

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

Endoscopic Ultrasound

Intervention Type: DIAGNOSTIC_TEST

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

Magnetic Resonance Imaging

Intervention Type: COMBINATION_PRODUCT

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

Magnetic Resonance Cholangiopancreatography

Intervention Type: COMBINATION_PRODUCT

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

Interventions

Screening Blood Tests

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

Intervention Type: OTHER

Endoscopic Ultrasound

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

Intervention Type: DIAGNOSTIC_TEST

Magnetic Resonance Imaging

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

Intervention Type: COMBINATION_PRODUCT

Magnetic Resonance Cholangiopancreatography

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

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

EUS; MRI; MRCP

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Matthew B. Yurgelun, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew Yurgelun, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status: NOT_YET_RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Matthew Yurgelun, MD

Role: CONTACT

matthew_yurgelun@dfci.harvard.edu

617-582-8673

Facility Contacts

Matthew Yurgelun, MD

Role: primary

matthew_yurgelun@dfci.harvard.edu

617-582-8673

Matthew Yurgelun, MD

Role: primary

matthew_yurgelun@dfci.harvard.edu

617-582-8673

Other Identifiers

23-147

Identifier Type: -

Identifier Source: org_study_id