Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New-Onset Diabetes Mellitus | Diabetes Mellitus diagnosed within the past 12 months |
| |
| Deteriorating Diabetes Mellitus | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI/MRCP | Diagnostic Test | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Early Stage Pancreatic Cancer or Precursor Lesions | Determine incidence of pancreatic cancer or precursor lesions in individuals with new-onset diabetes mellitus or deteriorating diabetes | Through study completion, up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Relative Risk of Pancreatic Cancer Among Individuals with New-Onset Diabetes | 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 | Through study completion, up to 3 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
50+ years of age. New-onset diabetes mellitus (diagnosed with within the preceding 12 months) or Deteriorating diabetes mellitus (spike in HbA1c within past 6 months without weight gain and medication non-compliance)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tammy Lo, MSN | Contact | 203-855-3551 | Tammy.Lo@nuvancehealth.org | |
| Pramila Krumholtz, MSN | Contact | 203-739-7997 | Pramila.Krumholtz@nuvancehealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Richard Frank, MD | Nuvance Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | Not yet recruiting | New Haven | Connecticut | 06520 | United States |
Not provided
| Label | URL |
|---|---|
| More information regarding the Pancreatic Cancer Screening Study may be found here | View source |
Not provided
De-identified participant data for all primary and secondary outcome measures will be made available
Data will be available within 6 months of study completion
Data access requests will be reviewed on an individual basis post submission. Requestors may be required to sign a data access agreement
Not provided
Not provided
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D003920 | Diabetes Mellitus |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Serum sample
| Relative Risk of Pancreatic Cancer Among Individuals with Detiorating diabetes |
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 |
| Through study completion, up to 3 years |
| Nuvance Health | Recruiting | Norwalk | Connecticut | 06856 | United States |
|
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |