Actively Recruiting
A Pancreatic Cancer Screening Study in Individuals With New-Onset or Deteriorating Diabetes Mellitus
Led by Nuvance Health · Updated on 2026-04-13
800
Participants Needed
2
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main goal of this study is to explore the relationship between new-onset diabetes mellitus/deteriorating diabetes and a subsequent diagnosis of pancreatic cancer. Magnetic Resonance Imaging and Magnetic cholangiopancreatography (MRI/MRCP) will be utilized to screen for early stage pancreatic cancer or precursor lesions. Participants will be asked to donate a blood sample at specific intervals for the creation of a bio-bank necessary for the development of a blood based screening test for pancreatic cancer.
CONDITIONS
Official 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.
- Diabetes mellitus diagnosed within the past 12 months with confirmed or unconfirmed duration.
- HbA1c level of 6.5% or higher if diabetes duration is confirmed or if there is one first-degree relative with diabetes.
- HbA1c level of 7.0% or higher if diabetes duration is unconfirmed.
- Transition from pre-diabetes to diabetes within the past 12 months with an HbA1c increase of 0.5% or more.
- Deteriorating diabetes characterized by a greater than 2% rise in HbA1c within the past 6 months not related to weight gain or medication non-compliance.
- ECOG performance status of 0-1.
- No known contraindications to MRI or gadolinium contrast.
- Willingness to undergo MRI and metal screening.
- Ability to provide informed consent.
- Willingness to return for all study assessments.
You will not qualify if you...
- Prior history of pancreatic cancer.
- Presence of metastatic cancer or cancer requiring chemotherapy within the past 5 years.
- Chemotherapy received within the past 6 months (hormonal therapy allowed if disease-free for at least 5 years).
- Hereditary pancreatitis.
- Use of high dose glucocorticoid steroids (20 mg prednisone daily or more) within 3 months of diabetes diagnosis or HbA1c elevation.
- Contraindications to MRI or gadolinium contrast.
- Pregnant or nursing women.
- Other serious illnesses or conditions that would make participation unsafe or inappropriate as judged by clinicians.
AI-Screening
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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
CONTACT
P
Pramila Krumholtz, MSN
CONTACT
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
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