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

Description

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

Study Overview

Study Details

Study overview

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.

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

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

Condition
Pancreatic Cancer
Intervention / Treatment

-

Contacts and Locations

Norwalk

Nuvance Health, Norwalk, Connecticut, United States, 06856

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Nuvance Health,

Richard Frank, MD, PRINCIPAL_INVESTIGATOR, Nuvance Health

Study Record Dates

2028-01-19