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

NCT ID: NCT07324096

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-15
• Study Completion Date: 2029-03-15

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 Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo blood sample collection

Computed Tomography with Contrast

Intervention Type: PROCEDURE

Undergo contrast-enhanced abdominal CT

Electronic Health Record Review

Intervention Type: OTHER

Undergo electronic medical record (EMR) surveillance

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.

Group Type: EXPERIMENTAL

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo blood sample collection

Electronic Health Record Review

Intervention Type: OTHER

Undergo electronic medical record (EMR) surveillance

Group B (EMR surveillance)

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

Group Type: ACTIVE_COMPARATOR

Electronic Health Record Review

Intervention Type: OTHER

Undergo electronic medical record (EMR) surveillance

Interventions

Biospecimen Collection

Undergo blood sample collection

Intervention Type: PROCEDURE

Computed Tomography with Contrast

Undergo contrast-enhanced abdominal CT

Intervention Type: PROCEDURE

Electronic Health Record Review

Undergo electronic medical record (EMR) surveillance

Intervention Type: OTHER

Other Intervention Names

Biological Sample Collection; Biospecimen Collected; Specimen Collection; Contrast Enhanced Computed Tomography; CONTRAST ENHANCED CT SCAN; Contrast-enhanced Computed Tomography; CT Scan With Contrast; CT with Contrast

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ajit H. Goenka, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Central Contacts

Clinical Trials Referral Office

Role: CONTACT

mayocliniccancerstudies@mayo.edu

855-776-0015

Alyssa Johnson

Role: CONTACT

507-422-9721

Facility Contacts

Alyssa Johnson

Role: primary

507-422-9721

Ashley Braen

Role: backup

507-266-0544

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

MC250406

Identifier Type: -

Identifier Source: org_study_id

NCI-2025-09279

Identifier Type: REGISTRY

Identifier Source: secondary_id

25-009433

Identifier Type: OTHER

Identifier Source: secondary_id

MC250406

Identifier Type: OTHER

Identifier Source: secondary_id