RECRUITING

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

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Conditions

Pancreatic CancerPancreatic NeoplasmsPancreasCancerDiabetes MellitusMRIEarly Detection

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2018-01-19
Study Completion:2028-01-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03937453

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:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age of at least 50 years.
  2. * 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
  3. * 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
  4. * Transition from pre-Diabetes to Diabetes Mellitus within the past 12 months characterized by a change in the HbA1c of ≥ 0.5% OR
  5. * 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
  6. * 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
  7. * ECOG Performance Status of 0-1.
  8. * No known contraindications to MRI examination or gadolinium contrast.
  9. * Willing to undergo MRI and screening for metal implants or metal injury.
  10. * Recent BUN and Cr
  11. * Estimated GFR (eGFR) must be greater than 30 mL/min.
  12. * Ability to provide informed consent.
  13. * Willing to return to study site for all study assessments.
  1. * Prior history of pancreatic cancer.
  2. * Presence of metastatic cancer or cancer requiring adjuvant chemotherapy within the past 5 years.
  3. * Received chemotherapy within the past 6 months. (Hormonal therapy is allowable if the disease free interval is at least 5 years).
  4. * Hereditary pancreatitis.
  5. * eGFR \< 30 mL/min.
  6. * Contraindication to MRI examination or gadolinium contrast.
  7. * Pregnant or nursing women.
  8. * 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.

Contacts and Locations

Study Contact

Tammy Lo, APRN
CONTACT
203-855-3551
Tammy.Lo@nuvancehealth.org
Pramila Krumholtz, RN
CONTACT
203-739-7997
Pramila.Krumholtz@nuvancehealth.org

Principal Investigator

Richard Frank, MD
PRINCIPAL_INVESTIGATOR
Nuvance Health

Study Locations (Sites)

Nuvance Health
Norwalk, Connecticut, 06856
United States

Collaborators and Investigators

Sponsor: Nuvance Health

  • Richard Frank, MD, PRINCIPAL_INVESTIGATOR, Nuvance Health

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

Study Start Date2018-01-19
Study Completion Date2028-01-19

Study Record Updates

Study Start Date2018-01-19
Study Completion Date2028-01-19

Terms related to this study

Keywords Provided by Researchers

  • Pancreas
  • Cancer
  • Diabetes Mellitus
  • MRI
  • Early Detection

Additional Relevant MeSH Terms

  • Pancreatic Cancer
  • Pancreatic Neoplasms