Screening Program for Early Detection of Pancreatic Cancer

(AI-PACED Trial)

CT
Overseen ByClinical Trials Referral Office
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new screening program to catch pancreatic cancer early in individuals at higher risk. It uses advanced CT scans (a type of detailed X-ray) with contrast and blood tests to detect cancer sooner. Individuals over 50 who have recently developed diabetes might be suitable candidates. Participants will be divided into groups receiving different combinations of scans, blood tests, and medical record checks over time. The goal is to find a better way to detect pancreatic cancer early when treatment is more effective. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to earlier detection and better outcomes for pancreatic cancer patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this screening program is safe for early detection of pancreatic cancer?

Research has shown that the special CT scans used in this study are generally easy for patients to handle. These scans provide more detailed images than regular x-rays and often check for pancreatic issues. Some people might feel warm or notice a metallic taste during the scan due to the contrast dye, but serious reactions are rare.

Taking blood samples is a common and safe procedure in many studies. It involves drawing a small amount of blood, similar to a routine blood test. Some people might experience slight discomfort or notice a small bruise where the needle was inserted, but these effects are usually mild and resolve quickly.

Overall, both the CT scans and blood tests in this screening program are considered safe with minimal risk of side effects.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to improve the early detection of pancreatic cancer, which is notoriously hard to catch early. The trial uses a combination of blood sample collection and enhanced medical record (EMR) surveillance, with some groups also undergoing contrast-enhanced CT scans. Unlike traditional methods, which often rely on symptoms or advanced imaging only after potential signs of cancer appear, this approach could identify cancer earlier by regularly monitoring biomarkers and imaging changes over time. This proactive screening could lead to earlier interventions and potentially better outcomes for patients.

What evidence suggests that this screening program is effective for early detection of pancreatic cancer?

Research shows that special CT scans, enhanced by artificial intelligence (AI), can better detect early-stage pancreatic cancer. In this trial, participants in Group A1 will undergo contrast-enhanced abdominal CT scans. Studies have found that these scans can identify small tumors more accurately than doctors, especially those smaller than 2 cm. This is crucial because traditional methods might miss nearly 40% of early-stage tumors. Additionally, participants in Groups A1 and A2 will have blood samples collected, which may help researchers understand why some people develop pancreatic cancer. This could lead to earlier detection and possibly better outcomes for those at high risk.678910

Who Is on the Research Team?

AH

Ajit H. Goenka, MD

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

This trial is for adults aged 50-85 with a high risk of pancreatic cancer, indicated by new-onset diabetes and an ENDPAC score ≥ 3. Participants must consent to the study's procedures.

Inclusion Criteria

I have given my consent in writing or remotely for participation.
My ENDPAC score for pancreatic cancer risk is 3 or higher.
I am between 50 and 85 years old.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline contrast-enhanced abdominal CT and blood sample collection

1 week
1 visit (in-person)

Surveillance

Participants undergo contrast-enhanced CT and blood sample collection at 6 and 12 months, with EMR surveillance for PDA diagnosis

12 months
2 visits (in-person)

Extended Follow-up

Participants continue EMR surveillance for PDA diagnosis

24 months

Follow-up

Participants are monitored for safety and effectiveness after the main surveillance period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Biospecimen Collection
  • Computed Tomography with Contrast

Trial Overview

The trial tests a screening program using AI-enhanced CT scans and blood tests to detect sporadic pancreatic cancer early in high-risk individuals.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Group A2 (blood, EMR surveillance)Experimental Treatment2 Interventions
Group II: Group A1 (CT, blood, EMR surveillance)Experimental Treatment3 Interventions
Group III: Group B (EMR surveillance)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Citations

A Screening Program to Improve the Early Detection of ...

This may be an effective way to screen high-risk individuals and improve the early detection of sporadic pancreatic cancer. Official Title.

Early detection of pancreatic cancer: Study design and ...

We highlight study design and statistical considerations that inform pancreatic cancer early detection biomarker evaluation.

Early detection of pancreatic cancer: current state and future ...

This review summarizes the known risk factors of PDAC, current knowledge and recent observations pertinent to early detection of PDAC in these risk groups.

Cost-Effectiveness of Pancreatic Cancer Screening in New ...

This economic evaluation examines the cost-effectiveness of 3 screening strategies for pancreatic ductal adenocarcinoma among individuals ...

How the Pancreatic Cancer Early Detection Consortium ...

For all stages combined, the 5-year relative survival rate is 11%.2. Improving survival outcomes for patients with this disease is the ...

Biospecimens for Identification of Diseases of the Pancreas.

This protocol is focused on collecting data, blood samples, and tissue on subjects with pancreatic diseases, including pancreatic cancer, pancreatic cysts, ...

Standard Operating Procedures for Biospecimen Collection ...

We report a methodology for the development of a robust standard operating procedure (SOP) for a biorepository based on the experience of the Clinical Centers ...

Configure Human Pancreatic Cancer Biofluids

IRB-approved pancreatic cancer plasma and serum samples with data on disease severity and treatment. Includes adenocarcinoma, SCC, and neuroendocrine types.

Recommendations, evidence and sustainability of ...

This review evaluates current recommendations for pancreatic cancer surveillance in high-risk individuals, synthesises evidence from recent studies and ...

Collecting Medical Information and Tissue Samples From ...

PURPOSE: This clinical trial is collecting medical information and tissue samples from patients with pancreatic cancer or other pancreatic disorders. Detailed ...