Actively Recruiting
Pancreatic Cancer Screening Study in People With New-Onset or Worsening Diabetes Mellitus (PANDOME Study)
Led by Nuvance Health · Updated on 2026-04-13
800
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to explore the link between new-onset or worsening diabetes and the later development of pancreatic cancer. It focuses on individuals over 50 years old who have either been diagnosed with diabetes within the past year or have experienced deteriorating diabetes recently. The study uses Magnetic Resonance Imaging and Magnetic Cholangiopancreatography (MRI/MRCP) to screen for early pancreatic cancer or its precursors, helping to identify risks earlier. Participants will undergo an MRI with contrast at the start of the study. Any abnormalities found will be reviewed by a team of specialists and discussed with the participant. Blood samples will be collected every six months for up to three years to create a bio-bank that supports developing a blood test for pancreatic cancer. Additional MRI scans may be done as needed based on expert recommendations. During the study, participants will complete a brief psychological survey and provide blood samples regularly. Researchers will monitor the presence of early pancreatic cancer or precursor lesions over three years. The study tracks the relative risk of pancreatic cancer among those with new or worsening diabetes. Participants must be willing to undergo MRI screening, provide informed consent, and attend all study visits during this period.
CONDITIONS
Brief Title
A Pancreatic Cancer Screening Study in Individuals With New-Onset or Deteriorating Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age of at least 50 years.
- Diagnosed with diabetes mellitus within the past 12 months with documented prior normal blood sugar tests or with an elevated HbA1c level.
- Transition from pre-diabetes to diabetes within the past 12 months with a significant increase in HbA1c.
- Diabetes diagnosed within the past 12 months in individuals with one first-degree relative with diabetes.
- Deteriorating diabetes shown by a rise in HbA1c greater than 2% in the past 6 months, confirmed by repeat testing, not linked to weight gain or medication non-compliance.
- ECOG Performance Status of 0-1.
- No known contraindications to MRI or gadolinium contrast.
- Willing to undergo MRI and screening for metal implants or injuries.
- Able to provide informed consent.
- Willing to attend all study visits.
You will not qualify if you...
- Prior history of pancreatic cancer.
- Metastatic cancer or cancer requiring chemotherapy within the past 5 years.
- Received chemotherapy within the past 6 months (hormonal therapy allowed if disease-free for 5 years).
- Hereditary pancreatitis.
- Use of high dose glucocorticoid steroids within 3 months of diabetes diagnosis or HbA1c elevation.
- Contraindications to MRI or gadolinium contrast.
- Pregnant or nursing women.
- Other illnesses or conditions that would make participation inappropriate as judged by clinicians.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline with additional scans as needed
Participants undergo an MRI scan at baseline to assess the pancreas. Additional MRI scans may be performed if abnormalities are found and recommended by the study committee.
1 baseline MRI visit plus additional visits as needed
Duration - Up to 3 years
Participants complete a five-minute psychological survey and donate a blood sample every 6 months for up to 3 years for bio-bank analysis and monitoring.
Visits every 6 months for up to 3 years
Trial Site Locations
Total: 2 locations
1
Yale University
New Haven, Connecticut, United States, 06520
Not Yet Recruiting
2
Nuvance Health
Norwalk, Connecticut, United States, 06856
Actively Recruiting
Research Team
T
Tammy Lo, MSN
P
Pramila Krumholtz, MSN
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here