A Screening Program to Improve the Early Detection of Sporadic Pancreatic Cancer in Individuals With a High-Risk of Developing Pancreatic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biospecimen Collection, Computed Tomography with Contrast, Electronic Health Record Review.
- Who it may be relevant to
- Registry conditions: Pancreatic Ductal Adenocarcinoma. Basic parameters: 50 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
MC250406 Feasibility Study: Automated Risk Stratification, Serial AI-Augmented Imaging, and Biobanking for Early Detection of Sporadic Pancreatic Cancer (AI-PACED)
Overview
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.
Interventions
- Procedure Biospecimen Collection
Undergo blood sample collection - Procedure Computed Tomography with Contrast
Undergo contrast-enhanced abdominal CT - Other Electronic Health Record Review
Undergo electronic medical record (EMR) surveillance
Primary outcome measures
- Recruitment yield (Feasibility) [Time frame: Up to 3 years]
- Imaging adherence rates (Feasibility) [Time frame: Up to 3 years]
- Blood collection success rates (Feasibility) [Time frame: Up to 3 years]
- Completeness of electronic medical record (EMR)-based follow-up (Feasibility) [Time frame: Up to 3 years]
Secondary outcome measures (4)
- Time from glycemically-defined new-onset diabetes (gNOD) onset to pancreatic ductal adenocarcinoma (PDA) diagnosis [Time frame: Up to 3 years]
- Proportion of PDAs diagnosed at stage 0/I [Time frame: Up to 3 years]
- Rate and type of incidental findings requiring downstream evaluation [Time frame: Up to 3 years]
- Artificial intelligence (AI)-detected imaging signatures and standard radiologist interpretations [Time frame: Up to 3 years]
Eligibility criteria
Inclusion criteria
- Age ≥ 50 and ≤ 85 years
- Glycemically-defined new-onset diabetes (gNOD) with onset ≤ 180 days preceding enrollment
- Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score ≥ 3, based on validated risk stratification models
- Provide written or remote informed consent
Exclusion criteria
- Prior diagnosis of pancreatic ductal adenocarcinoma (PDA)
- Known hereditary cancer syndromes (e.g., BRCA1/2, Lynch syndrome, Peutz-Jeghers)
- Prior history of pancreatic surgery
- Pancreatic cyst surveillance at time of registration
- Contraindications to contrast-enhanced CT imaging per standard clinical practice at time of registration
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT07324096 · MC250406 · NCI-2025-09279 · 25-009433 · MC250406