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NCT07324096Recruiting

A Screening Program to Improve the Early Detection of Sporadic Pancreatic Cancer in Individuals With a High-Risk of Developing Pancreatic Cancer

MC250406 Feasibility Study: Automated Risk Stratification, Serial AI-Augmented Imaging, and Biobanking for Early Detection of Sporadic Pancreatic Cancer (AI-PACED)

Source: ClinicalTrials.gov · Last updated 14 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
100 (estimated)
First submitted
23 Dec 2025
Start date
24 Mar 2026
Primary completion date
24 Mar 2029
Lead sponsor
Mayo Clinic
NCT number
NCT07324096

What you commit to

  • Study type: Interventional
  • Planned participants: 100
  • From 24 Mar 2026 to the primary completion date, 24 Mar 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior diagnosis of pancreatic ductal adenocarcinoma (PDA)
  • Prior history of pancreatic surgery

Other illness

  • Known hereditary cancer syndromes (e.g., BRCA1/2, Lynch syndrome, Peutz-Jeghers)

Other

  • Pancreatic cyst surveillance at time of registration
  • Contraindications to contrast-enhanced CT imaging per standard clinical practice at time of registration

Who the study is looking for

  • 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

Age in the registry: 50 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Mayo Clinic in Rochester
Coordinator of this site? Confirm its status
RochesterUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.