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

(PANDOME Trial)

Recruiting at 2 trial locations

Overseen By Pramila Krumholtz, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nuvance Health

Disqualifiers: Pancreatic cancer, Metastatic cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

800 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Richard Frank, MD

Principal Investigator

Nuvance Health

Eligibility Criteria

Inclusion Criteria

No known contraindications to MRI examination or gadolinium contrast.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo MRI and donate a blood sample for bio-bank analysis

1 day

1 visit (in-person)

Ongoing Monitoring

Participants complete a psychological survey and donate a blood sample every 6 months for 3 years

3 years

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the main study activities

4 weeks

Treatment Details

Interventions

• MRI/MRCP

Participant Groups

Group I: New-Onset Diabetes Mellitus Experimental Treatment 1 Intervention

Diabetes Mellitus diagnosed within the past 12 months

Group II: Deteriorating Diabetes Mellitus Experimental Treatment 1 Intervention

History of Diabetes Mellitus with recent deteriorating within the past 6 months confirmed with repeat testing and not associated with weight gain or diabetes medication non-compliance

Who Is Running the Clinical Trial?

Nuvance Health

Lead Sponsor

Trials

4

Recruited

1,200+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+