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

Summary

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.

Eligibility

Inclusion Criteria:

* 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.
* Recent BUN and Cr
* Estimated GFR (eGFR) must be greater than 30 mL/min.
* Ability to provide informed consent.
* Willing to return to study site for all study assessments.

Exclusion Criteria:

* 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.
* eGFR \< 30 mL/min.
* 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.

Conditions4

Locations1 site

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