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

Recruiting

• Conditions: Pancreatic Cancer; Pancreatic Neoplasms
• Interventions: Diagnostic Test: MRI/MRCP

• Registration Number: NCT03937453
• Lead Sponsor: Nuvance Health

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.

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 Timeline

• Study Start: 2018-01-19
• Study First Submitted: 2019-04-05
• Study First Submitted QC: 2019-05-02
• Study First Posted: 2019-05-03
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-29
• Last Update Posted: 2024-04-01
• Primary Completion: 2028-01-19
• Study Completion: 2028-01-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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.
• Recent BUN and Cr
• Estimated GFR (eGFR) must be greater than 30 mL/min.
• 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.
• eGFR < 30 mL/min.
• 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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
New-Onset Diabetes Mellitus	MRI/MRCP	Diabetes Mellitus diagnosed within the past 12 months
Deteriorating Diabetes Mellitus	MRI/MRCP	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

Primary Outcome Measures

Name	Time	Method
Early Stage Pancreatic Cancer or Precursor Lesions	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

Secondary Outcome Measures

Name	Time	Method
Relative Risk of Pancreatic Cancer Among Individuals with Detiorating diabetes	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
Relative Risk of Pancreatic Cancer Among Individuals with New-Onset Diabetes	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

Trial Locations

Locations (1)

Nuvance Health; 🇺🇸 Norwalk, Connecticut, United States