Recruiting

Pancreatic Cancer Screening

Sponsor:

Mayo Clinic

Code:

NCT07324096

Conditions

Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Computed Tomography with Contrast

Electronic Health Record Review

Study Details

Brief summary:

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.

Conditions

Pancreatic Ductal Adenocarcinoma

Study ID

NCT07324096

Start date

Mar 24, 2026

Status verified date

Mar, 2026

Completion date

Mar 24, 2029

Anticipated

Primary completion date

Mar 24, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

Biospecimen Collection

Undergo blood sample collection

Computed Tomography with Contrast

Undergo contrast-enhanced abdominal CT

Electronic Health Record Review

Undergo electronic medical record (EMR) surveillance

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Alyssa Johnson

507-422-9721

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Alyssa Johnson

507-422-9721

Ashley Braen

507-266-0544

Principal Investigator:

Ajit H. Goenka, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-03-27.