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

March 24, 2026 updated by: Mayo Clinic

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Alyssa Johnson
  • Phone Number: 507-422-9721

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:
          • Alyssa Johnson
          • Phone Number: 507-422-9721
        • Contact:
          • Ashley Braen
          • Phone Number: 507-266-0544
        • Principal Investigator:
          • Ajit H. Goenka, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Procedure: Computed Tomography with Contrast
Undergo contrast-enhanced abdominal CT
Other Names:
  • Contrast Enhanced Computed Tomography
  • CONTRAST ENHANCED CT SCAN
  • Contrast-enhanced Computed Tomography
  • CT Scan With Contrast
  • CT with Contrast
Other: Electronic Health Record Review
Undergo electronic medical record (EMR) surveillance
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.
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Other: Electronic Health Record Review
Undergo electronic medical record (EMR) surveillance
Active Comparator: Group B (EMR surveillance)
Patients undergo EMR surveillance for PDA diagnosis for up to 36 months.
Other: Electronic Health Record Review
Undergo electronic medical record (EMR) surveillance

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment yield (Feasibility)
Time Frame: Up to 3 years
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)
Time Frame: Up to 3 years
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)
Time Frame: Up to 3 years
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)
Time Frame: Up to 3 years
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time from glycemically-defined new-onset diabetes (gNOD) onset to pancreatic ductal adenocarcinoma (PDA) diagnosis
Time Frame: Up to 3 years
Time to PDA diagnosis will be compared between cohorts.
Up to 3 years
Proportion of PDAs diagnosed at stage 0/I
Time Frame: Up to 3 years
Comparisons between cohorts will employ log-rank tests. Will also employ Cox proportional hazards models adjusted for baseline covariates (exploratory only).
Up to 3 years
Rate and type of incidental findings requiring downstream evaluation
Time Frame: Up to 3 years
Comparisons between cohorts will employ log-rank tests. Will also employ Cox proportional hazards models adjusted for baseline covariates (exploratory only).
Up to 3 years
Artificial intelligence (AI)-detected imaging signatures and standard radiologist interpretations
Time Frame: Up to 3 years
Will complete discordance analysis between AI-detected imaging signatures and standard radiologist interpretations, including rates of earlier detection and false positives.
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ajit H. Goenka, MD, Mayo Clinic in Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 24, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 24, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 24, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 7, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MC250406 (Other Identifier: Mayo Clinic)
  • NCI-2025-09279 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • 25-009433 (Other Identifier: Mayo Clinic Institutional Review Board)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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