New Onset Diabetes Management for Earlier Detection of Pancreatic Cancer (NODMED)
Bluestar Genomics has developed a non-invasive test that aids in detection of occult pancreatic cancer in patients with new onset type II diabetes (NOD) who are 50 years old or older. The purpose of this study is to evaluate the performance of Bluestar Genomics early-detection pancreatic cancer test in a clinical setting. The study is prospective, longitudinal and interventional; tests will be ordered and results returned to site-investigators. If the test returns a pancreatic cancer signal "detected" result the study participant will undergo MRI imaging to evaluate for the presence of pancreatic cancer. The study is planned to enroll 6,550 newly diagnosed type 2 diabetic subjects according to inclusion and exclusion criteria.
Conditions:
🦠 Pancreatic Cancer
🗓️ Study Start (Actual) 6 December 2022
🗓️ Primary Completion (Estimated) 1 November 2024
✅ Study Completion (Estimated) 1 December 2024
👥 Enrollment (Estimated) 6500
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Scottsdale, Arizona, United States
📍 Atlantis, Florida, United States
📍 Greenville, South Carolina, United States
📍 Shavano Park, Texas, United States
📍 Manassas, Virginia, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • ≥ 50 years of age or older at the time of enrollment
    • Willing to sign the informed consent form
    • Must have 2 occurrences from among the below parameters of diabetes mellitus (PDMs) in past 90 days measured in outpatient setting (not in urgent care, emergency room or while inpatient):
    • FBG ≥126mg/dl HbA1c ≥6.5% RBG ≥ 200mg/dl 2-hour post-glucose ≥200mg/dl (OGTT)
    • Must have had glycemic parameter measured in 3-18 months prior to screening that did NOT meet DM criteria
    • Must be willing to provide several tubes of blood without endangering health
    • No history of pancreatic cancer or other known pancreatic neoplasia
    • No active cancers within the past 5 years (with the exception of non-melanoma skin cancers resolved/treated \> 1 year prior to enrollment and in situ cancers)

    Exclusion Criteria:

    • Prior DM diagnosis
    • Met criteria for DM ≥91 days prior to enrollment (patients with prior gestational diabetes that has resolved are NOT acceptable to enroll)
    • Carried a DM diagnosis or used anti-DM medications at a time greater than or equal to 91 days prior to enrollment
    • Any known pancreatic lesions (aside from diabetes)
    • Received cancer treatment within the past 5 years (with the exception of treatment of non-melanoma skin cancer), carrying a current cancer diagnosis, and/or being investigated for suspicion of past cancer recurrence.
    • Current chronic or acute oral steroid use
    • History of intra-articular steroid injections (\<1 week) of the qualifying DM blood test (allowed exception: nasal, topical, oral budesonide)
    • Any surgery requiring general anesthesia within 2 months of collection
    • Local anesthetic (including dental novocaine) within 1 week of collection
    • History or presence of HIV/AIDs, Hepatitis A or E within the past five years, TB, any kind of prion disorder (e.g., CJD)
    • Blood transfusion within 1 month
    • Organ transplant recipient
    • Currently pregnant, or pregnancy within last 12 months
    • Receipt of systemic immunomodulation therapy within past 12 months
    • Significant medical condition that in the site investigator's opinion would compromise the subject's ability to tolerate study interventions
Ages Eligible for Study: 50 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 27 December 2021
  • First Submitted that Met QC Criteria 27 December 2021
  • First Posted 12 January 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 6 December 2022
  • Last Update Posted 8 December 2022
  • Last Verified December 2022