A Screening Program to Improve the Early Detection of Sporadic Pancreatic Cancer in Individuals With a High-Risk of Developing Pancreatic Cancer
Part of paid clinical trials in Rochester, Minnesota.
- Sponsor
- Mayo Clinic
- Study ID
- NCT07324096
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- Biospecimen Collection — PROCEDUREUndergo blood sample collection
- Computed Tomography with Contrast — PROCEDUREUndergo contrast-enhanced abdominal CT
- Electronic Health Record Review — OTHERUndergo electronic medical record (EMR) surveillance
Study Details
This clinical trial studies a new screening program to improve the early detection of sporadic pancreatic cancer in individuals with a high risk of developing pancreatic cancer. Pancreatic cancer remains one of the deadliest solid tumors, characterized by a long phase without symptoms followed by rapid progression once clinically evident. Despite advancements in treatment, the survival rate for pancreatic cancer remains low. Research has helped to identify a subset of individuals with a markedly high short-term risk for developing pancreatic cancer, which includes adults aged 50 and older with glycemically-defined new-onset diabetes and an Enriching New-Onset Diabetes for Pancreatic Cancer (ENDPAC) score ≥ 3. However, current practice guidelines do not provide clear pathways for surveillance or early detection. The screening program in this trial combines repeated contrast-enhanced computed tomography (CT) scans using artificial intelligence (AI) and blood draws. Contrast-enhanced CT is an imaging technique which creates a series of detailed pictures of areas inside the body; the pictures are created by a computer linked to an x-ray machine and a contrast agent is used to enhance the images. The images are then reviewed using AI, which may make it easier to spot cancer earlier on the CT scans than with the human eye. Studying samples of blood in the laboratory from high-risk individuals may help doctors understand more about why they may develop pancreatic cancer. This may be an effective way to screen high-risk individuals and improve the early detection of sporadic pancreatic cancer.
Key Dates
- Start date
- Mar 24, 2026
- Status verified
- Mar 2026
- Primary completion
- Mar 24, 2029
- Completion
- Mar 24, 2029
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: Group A1 (CT, blood, EMR surveillance)Patients undergo contrast-enhanced abdominal CT and blood sample collection at baseline, 6 months, and 12 months in the absence of unacceptable toxicity. Patients also undergo EMR surveillance for PDA diagnosis for up to 36 months.
- Experimental: Group A2 (blood, EMR surveillance)Patients undergo blood sample collection at baseline, 6 months, and 12 months in the absence of unacceptable toxicity. Patients also undergo EMR surveillance for PDA diagnosis for up to 36 months.
- Active Comparator: Group B (EMR surveillance)Patients undergo EMR surveillance for PDA diagnosis for up to 36 months.
Primary Outcome Measure
Recruitment yield (Feasibility) [ Time Frame: Up to 3 years ]
Central Contacts
- Clinical Trials Referral Office855-776-0015
- Alyssa Johnson507-422-9721
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | Alyssa Johnson 507-422-9721 Ashley Braen 507-266-0544 Ajit H. Goenka, MD (PRINCIPAL_INVESTIGATOR) |
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