NCT03937453

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

A PAncreatic Cancer Screening Study in Individuals With New-Onset or DeteriOrating Diabetes MEllitus (PANDOME Study)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: Nuvance Health · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

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

Conditions

• Pancreatic Cancer
• Pancreatic Neoplasms
• Diabetes Mellitus

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	MRI/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

Timeline

• Start date: 2018-01-19
• Primary completion: 2028-01-19
• Completion: 2028-01-19
• First posted: 2019-05-03
• Last updated: 2026-04-13

Locations

2 sites across 1 country: United States