Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT06122896
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Screening Blood Tests — OTHER
    Carbohydrate antigen (CA) 19-9, and Hemoglobin A1C (HbA1c) per standard-of-care.
  • Endoscopic Ultrasound — DIAGNOSTIC_TEST
    Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.
  • Magnetic Resonance Imaging — COMBINATION_PRODUCT
    Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.
  • Magnetic Resonance Cholangiopancreatography — COMBINATION_PRODUCT
    Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.

Study Details

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.

Key Dates

Start date
Nov 21, 2023
Status verified
May 2026
Primary completion
Oct 31, 2040
Completion
Oct 31, 2041

Study Design

Enrollment
5,000 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

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

Primary Outcome Measure

Number of Incident Pancreatic Cancers or High-Grade Pancreatic Neoplasms [ Time Frame: 6-monthly for 3 years with 5-year follow-up ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02215
Matthew Yurgelun, MD
[email protected]
617-582-8673
Matthew Yurgelun, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02215
Matthew Yurgelun, MD
[email protected]
617-582-8673
Matthew B Yurgelun, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Brigham and Women's Hospital· Boston, MADana Farber Cancer Institute· Boston, MA

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