A Pancreatic Cancer Screening Study In Individuals With New-Onset Or Deteriorating Diabetes Mellitus

Study Overview

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

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.

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

Pancreatic Cancer
Pancreatic Neoplasms

DIAGNOSTIC_TEST: MRI/MRCP

18-01

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-04-05	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-03-29
First Submitted that Met QC Criteria 2019-05-02	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-04-01
First Posted (ACTUAL) 2019-05-03	Results First Posted N/A	Last Verified 2024-03

Study Plan

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

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/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 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

Participant Group/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 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

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
Relative Risk of Pancreatic Cancer Among Individuals with New-Onset Diabetes	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	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

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

Name: Tammy Lo, APRN

Phone Number: 203-855-3551

Email: Tammy.Lo@nuvancehealth.org

Study Contact Backup

Name: Pramila Krumholtz, RN

Phone Number: 203-739-7997

Email: Pramila.Krumholtz@nuvancehealth.org

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
50 Years

Accepts Healthy Volunteers:
1

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.

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.

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Richard Frank, MD, Nuvance Health

Publications

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

General Publications

No publications available

Learn

Resources

Patients

Caregivers

Clinical Trial Record