A Pancreatic Cancer Screening Study in Individuals With New-Onset or Deteriorating Diabetes Mellitus
Part of paid clinical trials in New Haven, Connecticut.
- Sponsor
- Nuvance Health
- Study ID
- NCT03937453
- Status
- Recruiting
Conditions
- Diabetes Mellitus
- Pancreatic Cancer
- Pancreatic Neoplasms
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- MRI/MRCP — DIAGNOSTIC_TESTAn 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
Study Details
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.
Key Dates
- Start date
- Jan 19, 2018
- Status verified
- Apr 2026
- Primary completion
- Jan 19, 2028
- Completion
- Jan 19, 2028
Study Design
- Enrollment
- 800 participants (estimated)
Arms
- Arm: New-Onset Diabetes MellitusDiabetes Mellitus diagnosed within the past 12 months
- Arm: Deteriorating Diabetes MellitusHistory 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
Primary Outcome Measure
Early Stage Pancreatic Cancer or Precursor Lesions [ Time Frame: Through study completion, up to 3 years ]
Central Contacts
- Tammy Lo, MSN203-855-3551
- Pramila Krumholtz, MSN203-739-7997
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06520 | James J Farrell, MD (PRINCIPAL_INVESTIGATOR) |
| Nuvance Health | Norwalk | Connecticut | 06856 | Richard Frank, MD (PRINCIPAL_INVESTIGATOR) |
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