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NCT Number: NCT07324096

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

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.

Recruiting

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Ajit H. Goenka, MD

PRINCIPAL_INVESTIGATOR

Alyssa Johnson

CONTACT

507-422-9721

Ashley Braen

CONTACT

507-266-0544

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biospecimen Collection

Procedure

Undergo blood sample collection

Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Computed Tomography with Contrast

Procedure

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

Electronic Health Record Review

Other

Undergo electronic medical record (EMR) surveillance

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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).

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alyssa Johnson

CONTACT

507-422-9721

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Acronym: AI-PACED

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jan 7, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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