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

NCT07324096 | Recruiting

• 3 other identifiers: MC250406NCI-2025-0927925-009433
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Recruitment yield (Feasibility)

  Will assess the feasibility of protocol implementation as defined by recruitment yield (% of flagged high-risk individuals who consent). Descriptive statistics will be used to summarize feasibility endpoints.

  Up to 3 years

• Imaging adherence rates (Feasibility)

  Will assess the feasibility of protocol implementation as defined by imaging adherence rates (% completing 3 scheduled computed tomography scans). Descriptive statistics will be used to summarize feasibility endpoints.

  Up to 3 years

• Blood collection success rates (Feasibility)

  Will assess the feasibility of protocol implementation as defined by blood collection success rates (% completing 3 scheduled blood collections). Descriptive statistics will be used to summarize feasibility endpoints.

  Up to 3 years

• Completeness of electronic medical record (EMR)-based follow-up (Feasibility)

  Will assess the feasibility of protocol implementation as defined by completeness of EMR-based follow-up (% of participants with outcome ascertainment). Descriptive statistics will be used to summarize feasibility endpoints.

  Up to 3 years

Secondary Outcomes (4)

• Time from glycemically-defined new-onset diabetes (gNOD) onset to pancreatic ductal adenocarcinoma (PDA) diagnosis

  Up to 3 years

• Proportion of PDAs diagnosed at stage 0/I

  Up to 3 years

• Rate and type of incidental findings requiring downstream evaluation

  Up to 3 years

• Artificial intelligence (AI)-detected imaging signatures and standard radiologist interpretations

  Up to 3 years

Study Arms (3)

Group A1 (CT, blood, EMR surveillance)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Procedure: Computed Tomography with Contrast; Other: Electronic Health Record Review

Group A2 (blood, EMR surveillance)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Other: Electronic Health Record Review

Group B (EMR surveillance)

ACTIVE COMPARATOR

Patients undergo EMR surveillance for PDA diagnosis for up to 36 months.

Other: Electronic Health Record Review

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Group A1 (CT, blood, EMR surveillance); Group A2 (blood, EMR surveillance)

Computed Tomography with Contrast PROCEDURE

Undergo contrast-enhanced abdominal CT

Also known as: Contrast Enhanced Computed Tomography, CONTRAST ENHANCED CT SCAN, Contrast-enhanced Computed Tomography, CT Scan With Contrast, CT with Contrast

Group A1 (CT, blood, EMR surveillance)

Electronic Health Record Review OTHER

Undergo electronic medical record (EMR) surveillance

Group A1 (CT, blood, EMR surveillance); Group A2 (blood, EMR surveillance); Group B (EMR surveillance)

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Specimen Handling; Contrast Media

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Ajit H. Goenka, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Alyssa Johnson

CONTACT

507-422-9721

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All CT scans obtained under the study will be interpreted by qualified radiologists who are not part of the study team and are blinded to study objectives.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 7, 2026
• Study Start: March 24, 2026
• Primary Completion (Estimated): March 24, 2029
• Study Completion (Estimated): March 24, 2029
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)