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

NCT03937453 | Recruiting DMC

• 1 other identifier: 18-01
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pancreatic Cancer; Pancreatic Neoplasms; Diabetes Mellitus

Keywords

Pancreas; Cancer; Diabetes Mellitus; MRI; Early Detection; Screening

Outcome Measures

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

  Through study completion, up to 3 years

Secondary Outcomes (2)

• Relative Risk of Pancreatic Cancer Among Individuals with New-Onset Diabetes

  Through study completion, up to 3 years

• Relative Risk of Pancreatic Cancer Among Individuals with Detiorating diabetes

  Through study completion, up to 3 years

Study Arms (2)

New-Onset Diabetes Mellitus

Diabetes Mellitus diagnosed within the past 12 months

Diagnostic Test: MRI/MRCP

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

Interventions

MRI/MRCP DIAGNOSTIC_TEST

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; New-Onset Diabetes Mellitus

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nuvance Health: lead

Study Sites (2)

Yale University

New Haven, Connecticut, 06520, United States

NOT YET RECRUITING

Nuvance Health

Norwalk, Connecticut, 06856, United States

RECRUITING

Related Links

• More information regarding the Pancreatic Cancer Screening Study may be found here

Biospecimen

Retention: SAMPLES WITH DNA

Serum sample

MeSH Terms

Conditions

Pancreatic Neoplasms; Diabetes Mellitus; Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Richard Frank, MD

  Nuvance Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tammy Lo, MSN

CONTACT

203-855-3551; Tammy.Lo@nuvancehealth.org

Pramila Krumholtz, MSN

CONTACT

203-739-7997; Pramila.Krumholtz@nuvancehealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cancer Research

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: May 3, 2019
• Study Start: January 19, 2018
• Primary Completion (Estimated): January 19, 2028
• Study Completion (Estimated): January 19, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data will be available within 6 months of study completion
• Access Criteria: Data access requests will be reviewed on an individual basis post submission. Requestors may be required to sign a data access agreement

Locations

US (2)