New Onset Diabetes Management for Earlier Detection of Pancreatic Cancer (NODMED)

NCT05188586 | Terminated DMC

• 1 other identifier: NODMED
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 5

Brief Summary

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

Keywords

Early Detection; New Onset Diabetes

Outcome Measures

Primary Outcomes (3)

• Positive Predictive Value (PPV)

  defined as the proportion of participants with pancreatic neoplasia diagnosis out of all subjects with pancreatic signal "detected" test result.

  12 months or until diagnostic resolution

• Negative Predictive Value (NPV)

  defined as the proportion of participants with no pancreatic neoplasia diagnosis out of all the subjects with pancreatic signal "not detected" test results.

  12 months or until diagnostic resolution

• Specificity

  defined as the proportion of participants with pancreatic signal "not detected" results out of all subjects with no pancreatic neoplasia diagnosis.

  12 months or until diagnostic resolution

Secondary Outcomes (2)

• Time to pancreatic cancer diagnosis

  12 months or until diagnostic resolution

• Stage Shift

  12 months or until diagnostic resolution

Study Arms (2)

Pancreatic Cancer Signal Detection = Detected

OTHER

Subjects with test results "detected" will undergo MRI/Imaging

Other: MRI/Imaging

Pancreatic Cancer Signal Detection = Not Detected

NO INTERVENTION

Interventions

MRI/Imaging OTHER

Blood collection and pancreatic cancer early detection testing with return of results.

Pancreatic Cancer Signal Detection = Detected

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• ClearNote Health: lead

Study Sites (5)

Headlands Research - Scottsdale - PPDS

Scottsdale, Arizona, 85260-6411, United States

Location

JEM Research Institute - Headlands - PPDS

Atlantis, Florida, 33462-6631, United States

Location

Prisma Health/Endocrinology specialist and Thyroid

Greenville, South Carolina, 29605-4289, United States

Location

Consano Clinical Research, LLC

Shavano Park, Texas, 78231-1281, United States

Location

Manassas Clinical Research Center

Manassas, Virginia, 20110-4421, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Samuel Levy, PhD

  ClearNote Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: January 12, 2022
• Study Start: October 31, 2022
• Primary Completion: March 16, 2023
• Study Completion: March 16, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)