A Pancreatic Cancer Screening Study in Individuals With New-Onset or Deteriorating Diabetes Mellitus (PANDOME)

April 6, 2026 updated by: Richard Frank, Nuvance Health

A PAncreatic Cancer Screening Study in Individuals With New-Onset or DeteriOrating Diabetes MEllitus (PANDOME Study)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Not yet recruiting
        • Yale University
        • Principal Investigator:
          • James J Farrell, MD
      • Norwalk, Connecticut, United States, 06856
        • Recruiting
        • Nuvance Health
        • Principal Investigator:
          • Richard Frank, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study 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)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
New-Onset Diabetes Mellitus
Diabetes Mellitus diagnosed within the past 12 months
Diagnostic test: MRI/MRCP
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
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
Diagnostic test: MRI/MRCP
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early Stage Pancreatic Cancer or Precursor Lesions
Time Frame: Through study completion, up to 3 years
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative Risk of Pancreatic Cancer Among Individuals with New-Onset Diabetes
Time Frame: Through study completion, up to 3 years
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
Relative Risk of Pancreatic Cancer Among Individuals with Detiorating diabetes
Time Frame: Through study completion, up to 3 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nuvance Health

Collaborators

Yale University

Investigators

  • Principal Investigator: Richard Frank, MD, Nuvance Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2018

Primary Completion (Estimated)

January 19, 2028

Study Completion (Estimated)

January 19, 2028

Study Registration Dates

First Submitted

April 5, 2019

First Submitted That Met QC Criteria

May 2, 2019

First Posted (Actual)

May 3, 2019

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-01 (National Center for Advancing Translational Sciences (NCATS))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified participant data for all primary and secondary outcome measures will be made available

IPD Sharing Time Frame

Data will be available within 6 months of study completion

IPD Sharing Access Criteria

Data access requests will be reviewed on an individual basis post submission. Requestors may be required to sign a data access agreement

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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