Diabetes Mellitus, Pancreatic Cancer, Pancreatic Neoplasms
Conditions
Keywords
Pancreas, Cancer, Diabetes Mellitus, MRI, Early Detection, Screening
Brief 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.
Detailed description
Individuals over 50 years of age who have developed new-onset diabetes mellitus (diagnosed within the past 12 months) or deteriorating diabetes will be recruited through the offices of primary care physicians and endocrinologists. Those meeting initial criteria will meet with a research APRN and will undergo a secondary screen to determine eligibility. Individuals enrolled in the study will undergo a five-minute psychological survey and donation of a blood sample for bio-bank analysis every 6 months for 3 years. MRI will be performed at baseline. Any abnormalities on MRI will be reviewed by a multi-disciplinary tumor board and discussed with the participant. Additional MRI will be performed on case-by-case basis
Interventions
DIAGNOSTIC_TESTMRI/MRCP
An MRI/MRCP with IV gadolinium contrast with high resolution imaging of the pancreas will be performed at baseline. Further imaging upon recommendation by study committee
Sponsors
Nuvance Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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. * 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early Stage Pancreatic Cancer or Precursor Lesions | Through study completion, up to 3 years | Determine incidence of pancreatic cancer or precursor lesions in individuals with new-onset diabetes mellitus or deteriorating diabetes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative Risk of Pancreatic Cancer Among Individuals with New-Onset Diabetes | Through study completion, up to 3 years | Assess utility of MRI as a screening tool for pancreatic cancer and ascertain relative risk of pancreatic cancer in study population of individuals with new-onset diabetes compared to a normal population of the same age |
| Relative Risk of Pancreatic Cancer Among Individuals with Detiorating diabetes | Through study completion, up to 3 years | Assess utility of MRI as a screening tool for pancreatic cancer and ascertain relative risk of pancreatic cancer in study population of individuals with deteriorating diabetes compared to a normal population of the same age |
Countries
United States
Contacts
CONTACTTammy Lo, MSN
CONTACTPramila Krumholtz, MSN
PRINCIPAL_INVESTIGATORRichard Frank, MD
Nuvance Health
Outcome results
None listed