A Pancreatic Cancer Screening Study in Individuals With New-Onset or Deteriorating Diabetes Mellitus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorNuvance Health
About 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Prior history of pancreatic cancer.
Presence of metastatic cancer or cancer requiring adjuvant chemotherapy within the past 5 years.
Received chemotherapy within the past 6 months. (Hormonal therapy is allowable if the disease free interval is at least 5 years).
Hereditary pancreatitis.
Trial population
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)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
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
Treatment groups
800 Participants
are divided into 2 treatment groupsGroup A: New-Onset Diabetes Mellitus1 intervention
Group B: Deteriorating Diabetes Mellitus1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Through study completion, up to 3 yearsSecondary outcomes
1
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
Time frame
Through study completion, up to 3 years2
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
Time frame
Through study completion, up to 3 yearsSponsors and contacts
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Source ClinicalTrials.gov