A Pancreatic Cancer Screening Study in Individuals With New-Onset or Deteriorating Diabetes Mellitus

Recruiting now

Conditions studied: Pancreatic Cancer, Pancreatic Neoplasms, Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT03937453

Run by

Nuvance Health

People needed

800

Starts

2018-01-19

Expected to finish

2028-01-19

Last updated by the study team

2026-04-13

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age of at least 50 years.
• DM of Confirmed Duration: DM diagnosed within the past 12 months AND documentation of prior normal FPG, OGTT or HbA1c levels within the past 2 years. Requirement for HbA1c ≥ 6.5% OR
• DM of Unconfirmed Duration: DM diagnosed within the past 12 months BUT no prior record of normal FPG, HbA1c or OGTT within the past 2 years. Requirement for HbA1c ≥ 7.0% OR
• Transition from pre-Diabetes to Diabetes Mellitus within the past 12 months characterized by a change in the HbA1c of ≥ 0.5% OR
• DM With Only One FDR: DM diagnosed within the past 12 months that is of Confirmed or Unconfirmed Duration, in an individual with 1 FDR. Requirement for HbA1c ≥ 6.5%. OR
• Deteriorating Diabetes: DM with >2% spike in HbA1c within past 6 months confirmed with repeat testing and NOT associated with weight gain and diabetes medication non-compliance
• ECOG Performance Status of 0-1.
• No known contraindications to MRI examination or gadolinium contrast.
• Willing to undergo MRI and screening for metal implants or metal injury.
• Ability to provide informed consent.
• Willing to return to study site for all study assessments.

You may not qualify if…

• Prior history of pancreatic cancer.
• Presence of metastatic cancer or cancer requiring adjuvant chemotherapy within the past 5 years.
• Received chemotherapy within the past 6 months. (Hormonal therapy is allowable if the disease free interval is at least 5 years).
• Hereditary pancreatitis.
• Use of high dose glucocorticoid steroids (at least 20 mg daily of prednisone) within 3 months of diabetes diagnosis or elevation of HbA1c. Lower doses of steroid use as a cause of glucocorticoid-induced diabetes will be made on a case-by-case basis.
• Contraindication to MRI examination or gadolinium contrast.
• Pregnant or nursing women.
• Co-morbid illnesses or other concurrent disease which, in the judgment of the clinicians obtaining informed consent, would make the participant inappropriate for entry into this study.

Where it is running

• Nuvance Health — Norwalk, Connecticut, United States (enrolling)
• Yale University — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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