A Pancreatic Cancer Screening Study in High Risk Individuals Including Those With New-Onset Diabetes Mellitus

Individuals between 50-80 years of age who have developed diabetes mellitus within the
preceding year or who have a family history of pancreatic cancer will be recruited through
the offices of primary care physicians and endocrinologists. Those meeting initial criteria
will meet with a research nurse and will undergo a secondary screen to determine eligibility.
Individuals enrolled in the study will undergo a ten-minute psychological survey and donation
of a blood sample for bio-bank analysis every 6 months for 3 years. MRI will be performed
annually for 3 years (4 in total). Any abnormalities on MRI will be reviewed by a
multi-disciplinary tumor board and discussed with the participant. The costs of MRI will be
covered by the study.

Registration-Inclusion Criteria for new-onset diabetes mellitus (Group 1)

1. Age between 50-80 years.

2. 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

3. 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 > 7.5%

OR

4. Transition from pre-Diabetes to Diabetes Mellitus within the past 12 months
characterized by a change in the HbA1c of > 1.5%.

OR

5. 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%.

6. ECOG Performance Status of 0-1.

7. No known contraindications to MRI examination or gadolinium contrast

8. Willing to undergo MRI and screening for metal implants or metal injury.

9. BUN and Cr performed within 30 days.

10. Estimated GFR (eGFR) must be greater than 40 mL/min.

11. Ability to provide informed consent.

12. Willing to return to study site for all study assessments.

Registration-Inclusion Criteria for FAMILIAL PANCREATIC CANCER (FPC) and those with a
BRCA1, BRCA2, LYNCH SYNDROME, ATM, or PALB2 gene mutation (one of the following is required
for questions 1-3)

1. For FPC: The individual has at least 2 first-degree relatives (FDR) with PC.

2. For FPC: The individual has at least 3 first-, second-, or third-degree relatives with
PC with at least 1 PC in a FDR.

3. The individual is a known mutation carrier of BRCA1, BRCA2, MLH1, MSH2, MSH6, or PMS2,
ATM or PALB2 and has at least 1 first- or second-degree relative with PC.

4. The individual is at least 50 years old or 10 years younger than the youngest relative
with PC.

5. Family and genetic history confirmed by genetics counselor at WCHN.

6. ECOG Performance Status of 0-1.

7. No known contraindications to MRI examination or gadolinium contrast.

8. Willing to undergo MRI and screening for metal implants or metal injury.

9. BUN and Cr performed within 30 days.

10. Estimated GFR (eGFR) must be greater than 40 mL/min.

11. Ability to provide informed consent.

12. Willing to return to study site for all study assessments.

Registration-Exclusion Criteria:

1. Prior history of pancreatic cancer.

2. Presence of metastatic cancer or cancer requiring adjuvant chemotherapy within the
past 5 years.

3. Received chemotherapy within the past 6 months. (Hormonal therapy is allowable if the
disease free interval is at least 5 years).

4. Hereditary pancreatitis.

5. eGFR < 40 mL/min

6. Contraindication to MRI examination or gadolinium contrast.

7. Pregnant or nursing women.

8. 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.