Pancreatic Ductal AdenocarcinomaAI-PACEDNCT07324096
A Screening Program to Improve the Early Detection of Sporadic Pancreatic Cancer in Individuals With a High-Risk of Developing Pancreatic Cancer
A study testing Biospecimen Collection, Computed Tomography with Contrast and Electronic Health Record Review in people with Pancreatic Ductal Adenocarcinoma, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Biospecimen Collection, Computed Tomography with Contrast and Electronic Health Record Review
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2026to 24 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alyssa Johnson contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Alyssa Johnson, 507-422-9721
Ashley Braen, 507-266-0544
About this study
Official title: 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.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- Biospecimen Collection, Computed Tomography with Contrast, Electronic Health Record Review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Computed Tomography with ContrastProcedure or surgery
Also called Contrast Enhanced Computed Tomography, CONTRAST ENHANCED CT SCAN, Contrast-enhanced Computed Tomography, CT Scan With Contrast
Undergo contrast-enhanced abdominal CT
Electronic Health Record ReviewOther
Undergo electronic medical record (EMR) surveillance
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Electronic Health Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 3 years
Secondary outcomes (4)
Time from glycemically-defined new-onset diabetes (gNOD) onset to pancreatic ductal adenocarcinoma (PDA) diagnosis
Time to PDA diagnosis will be compared between cohorts.
Measured: Up to 3 years
Proportion of PDAs diagnosed at stage 0/I
Comparisons between cohorts will employ log-rank tests. Will also employ Cox proportional hazards models adjusted for baseline covariates (exploratory only).
Measured: Up to 3 years
Rate and type of incidental findings requiring downstream evaluation
Comparisons between cohorts will employ log-rank tests. Will also employ Cox proportional hazards models adjusted for baseline covariates (exploratory only).
Measured: Up to 3 years
Artificial intelligence (AI)-detected imaging signatures and standard radiologist interpretations
Will complete discordance analysis between AI-detected imaging signatures and standard radiologist interpretations, including rates of earlier detection and false positives.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start24 Mar 2026
- Primary completion24 Mar 2029 (estimated)
- Study completion24 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ajit H. Goenka, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324096
- Sponsor's protocol ID
- MC250406
- Other IDs
- NCI-2025-09279, 25-009433, MC250406
- Acronym
- AI-PACED
- Status last verified
- Oct 2026
- First submitted
- 23 Dec 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MC250406 Feasibility Study: Automated Risk Stratification, Serial AI-Augmented Imaging, and Biobanking for Early Detection of Sporadic Pancreatic Cancer (AI-PACED)
- ClinicalTrials.gov ID
- NCT07324096
- Acronym / sponsor ID
- AI-PACED / MC250406
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- 24 Mar 2029 (estimated)
- Study completion
- 24 Mar 2029 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A1 (CT, blood, EMR surveillance) | Experimental | Procedure: Biospecimen Collection, Procedure: Computed Tomography with Contrast, Other: Electronic Health Record ReviewPatients 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 A2 (blood, EMR surveillance) | Experimental | Procedure: Biospecimen Collection, Other: Electronic Health Record ReviewPatients 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 B (EMR surveillance) | Active comparator | Other: Electronic Health Record ReviewPatients undergo EMR surveillance for PDA diagnosis for up to 36 months. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Group A1 (CT, blood, EMR surveillance), Group A2 (blood, EMR surveillance) |
| Computed Tomography with ContrastAlso: Contrast Enhanced Computed Tomography, CONTRAST ENHANCED CT SCAN, Contrast-enhanced Computed Tomography, CT Scan With ContrastUndergo contrast-enhanced abdominal CT | Procedure or surgery | Group A1 (CT, blood, EMR surveillance) |
| Electronic Health Record ReviewUndergo electronic medical record (EMR) surveillance | Other | Group A1 (CT, blood, EMR surveillance), Group A2 (blood, EMR surveillance), Group B (EMR surveillance) |
Primary outcome
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.
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.
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.
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.
4 secondary outcomes
Time from glycemically-defined new-onset diabetes (gNOD) onset to pancreatic ductal adenocarcinoma (PDA) diagnosis
Time frame: Up to 3 years
Proportion of PDAs diagnosed at stage 0/I
Time frame: Up to 3 years
Rate and type of incidental findings requiring downstream evaluation
Time frame: Up to 3 years
Artificial intelligence (AI)-detected imaging signatures and standard radiologist interpretations
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alyssa Johnson contact
Ajit H. Goenka, MD principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biospecimen Collection, Computed Tomography with Contrast and Electronic Health Record Review in people with Pancreatic Ductal Adenocarcinoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment yield (Feasibility) (time frame: Up to 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.