Screening for pancreatic cancer in people with new or worsening diabetes
A PAncreatic Cancer Screening Study in Individuals With New-Onset or DeteriOrating Diabetes MEllitus (PANDOME Study)
This study is testing if people over 50 with new or worsening diabetes might have pancreatic cancer and will use imaging and blood samples to look for early signs of the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Nuvance Health Academic / other |
| Drugs / interventions | chemotherapy, prednisone |
| Locations | 2 sites (New Haven, Connecticut and 1 other locations) |
| Trial ID | NCT03937453 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the link between new-onset or deteriorating diabetes mellitus and the diagnosis of pancreatic cancer. Participants aged 50 and older will be recruited and undergo MRI and MRCP imaging to detect early-stage pancreatic cancer or precursor lesions. Additionally, blood samples will be collected every six months for three years to create a bio-bank for future blood-based screening tests. The study will also include psychological assessments to support participant well-being.
Who should consider this trial
Good fit: Ideal candidates are individuals over 50 years old with new-onset diabetes diagnosed within the past 12 months or those experiencing deteriorating diabetes.
Not a fit: Patients with diabetes diagnosed for more than 12 months or those without significant changes in their diabetes status may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection of pancreatic cancer in individuals with diabetes, improving treatment outcomes.
How similar studies have performed: While the approach of using diabetes as a screening tool for pancreatic cancer is being explored, this specific methodology involving MRI and bio-banking is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New Haven, Connecticut and 1 other locations
- Yale University — New Haven, Connecticut, United States (Not_yet_recruiting)
- Nuvance Health — Norwalk, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Richard Frank, MD — Nuvance Health
- Study coordinator: Tammy Lo, MSN
- Email: Tammy.Lo@nuvancehealth.org
- Phone: 203-855-3551
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.