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

Sponsor

Nuvance Health (Other)

Overall Status

Recruiting

CT.gov ID

NCT03937453

Collaborator

Yale University (Other)

800

Enrollment

Locations

120

Anticipated Duration (Months)

400

Patients Per Site

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main goal of this study is to explore the relationship between new-onset diabetes mellitus 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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer Pancreatic Neoplasms	Diagnostic Test: MRI/MRCP

Detailed Description

Individuals between 50-80 years of age who have developed diabetes mellitus within the preceding year will be recruited through the offices of primary care physicians and endocrinologists. Those meeting initial criteria will meet with a research nurse 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 annually for 2 years (3 in total). Any abnormalities on MRI will be reviewed by a multi-disciplinary tumor board and discussed with the participant.

Study Design

Study Type:

Observational

Anticipated Enrollment :

800 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 19, 2018

Anticipated Primary Completion Date :

Jan 19, 2028

Anticipated Study Completion Date :

Jan 19, 2028

Arms and Interventions

Arm	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 annually

Arm

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 annually

Outcome Measures

Primary Outcome Measures

Early Stage Pancreatic Cancer or Precursor Lesions [Through study completion, up to 3 years]
Determine incidence of pancreatic cancer or precursor lesions within a population of new-onset diabetes mellitus individuals

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age between 50-80 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%.
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 40 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 < 40 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.