A Pancreatic Cancer Screening Study in Individuals With New-Onset or Deteriorating Diabetes Mellitus
Recruiting · NCT03937453 · Observational (researchers observe without assigning treatment) · Lead sponsor: Nuvance Health
View the official record on ClinicalTrials.gov →Interventions studied
MRI/MRCP
What this trial is about
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.
Who can take part
Age range
50 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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
- ECOG Performance Status of 0-1.
- No known contraindications to MRI examination or gadolinium contrast.
- Willing to undergo MRI and screening for metal implants or metal injury.
- Ability to provide informed consent.
- Willing to return to study site for all study assessments.
Exclusion criteria
- 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.
- Use of high dose glucocorticoid steroids (at least 20 mg daily of prednisone) within 3 months of diabetes diagnosis or elevation of HbA1c. Lower doses of steroid use as a cause of glucocorticoid-induced diabetes will be made on a case-by-case basis.
- Contraindication to MRI examination or gadolinium contrast.
- Pregnant or nursing women.
- Co-morbid illnesses or other concurrent disease which, in the judgment of the clinicians obtaining informed consent, would make the participant inappropriate for entry into this study.
Where it is running
2 locations listed across 1 US state.
- Yale University - New Haven, Connecticut, United States
- Nuvance Health - Norwalk, Connecticut, United States