NCT03937453Recruiting
A Pancreatic Cancer Screening Study in Individuals With New-Onset or Deteriorating Diabetes Mellitus
A PAncreatic Cancer Screening Study in Individuals With New-Onset or DeteriOrating Diabetes MEllitus (PANDOME Study)
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 800 (estimated)
- First submitted
- 5 Apr 2019
- Start date
- 19 Jan 2018
- Primary completion date
- 19 Jan 2028
- Lead sponsor
- Nuvance Health
- Diseases
- Pancreatic cancer
- NCT number
- NCT03937453
What you commit to
- Study type: Observational
- Planned participants: 800
- From 19 Jan 2018 to the primary completion date, 19 Jan 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of pancreatic cancer.
- Received chemotherapy within the past 6 months. (Hormonal therapy is allowable if the disease free interval is at least 5 years).
- 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.
Other illness
- Presence of metastatic cancer or cancer requiring adjuvant chemotherapy within the past 5 years.
Lab values
- 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.
Other
- Hereditary pancreatitis.
- Contraindication to MRI examination or gadolinium contrast.
- Pregnant or nursing women.
Who the study is looking for
- 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.
Age in the registry: 50 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Not yet recruiting |
| Nuvance Health Coordinator of this site? Confirm its status | Norwalk | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.