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

• ClinicalTrials.gov Identifier: NCT05188586
• Recruitment Status: Recruiting
• First Posted: January 12, 2022
• Last Update Posted: December 8, 2022
• Sponsor: ClearNote Health
• Information provided by (Responsible Party): ClearNote Health

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pancreatic Cancer	Other: MRI/Imaging	Not Applicable

Detailed Description:

This is a prospective longitudinal and interventional study of the Bluestar Genomics early detection pancreatic cancer test. The test will be ordered and results returned to site-investigators. The study is planned to enroll 6,550 male and female, ≥ 50 years of age and newly diagnosed with type II diabetes (within 90 days prior to enrollment). NOD subjects will be assessed for eligibility and consented. Each subject can undergo up to 2 blood draws and electronic medical record search at 12 months from diabetes diagnosis.

The study population will be targeted to enroll a subjects with a BMI < 32. Subjects ≥ 50 years of age will be divided into two cohorts based on age as described below:

Cohort 1 = 65 years old or older Time 0 (T0) = blood draw within 90 days of diabetes diagnosis Time 1 (T1) = blood draw 6 month draw from diabetes diagnosis Time 2 (T2) = 12 months from diabetes diagnosis, no blood draw, only medical record search for all patients for evidence of pancreatic neoplasia developed after T1.

Cohort 2 = 50 - 64 years old Time 0 (T0) = blood draw within 90 days of diabetes diagnosis Time 1 (T1) = blood draw 6 month draw from diabetes diagnosis Time 2 (T2) = 12 months from diabetes diagnosis, no blood draw, only medical record search for all patients for evidence of pancreatic neoplasia developed after T1.

Imaging Strategy MRI imaging (or alternate imaging if subject is unable to undergo MRI) will be performed on subjects whose test result is "detected".

If the imaging study results are abnormal, the subject will be referred back to their enrolling clinician for additional diagnostic work up as part of routine healthcare. If pancreatic cancer or other pancreatic lesion is diagnosed, the diagnostic reports will be collected as part of the study clinical data.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 6500 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: New Onset Diabetes Management for Earlier Detection of Pancreatic Cancer (NODMED)
• Estimated Study Start Date: December 6, 2022
• Estimated Primary Completion Date: November 1, 2024
• Estimated Study Completion Date: December 1, 2024

Arms and Interventions

Arm	Intervention/treatment
Pancreatic Cancer Signal Detection = Detected; Subjects with test results "detected" will undergo MRI/Imaging	Other: MRI/Imaging; Blood collection and pancreatic cancer early detection testing with return of results.
No Intervention: Pancreatic Cancer Signal Detection = Not Detected

Outcome Measures

Primary Outcome Measures :

1. Positive Predictive Value (PPV) [ Time Frame: 12 months or until diagnostic resolution ]
   defined as the proportion of participants with pancreatic neoplasia diagnosis out of all subjects with pancreatic signal "detected" test result.
2. Negative Predictive Value (NPV) [ Time Frame: 12 months or until diagnostic resolution ]
   defined as the proportion of participants with no pancreatic neoplasia diagnosis out of all the subjects with pancreatic signal "not detected" test results.
3. Specificity [ Time Frame: 12 months or until diagnostic resolution ]
   defined as the proportion of participants with pancreatic signal "not detected" results out of all subjects with no pancreatic neoplasia diagnosis.

Secondary Outcome Measures :

1. Time to pancreatic cancer diagnosis [ Time Frame: 12 months or until diagnostic resolution ]
   Median time to pancreatic cancer diagnosis (using Pancreatic Cancer Signal Detection testing) relative to new onset diabetes (NOD) diagnosis compared to Median time to pancreatic cancer diagnosis relative to NOD diagnosis in the absence of Pancreatic Cancer Signal Detection testing, based on published data
2. Stage Shift [ Time Frame: 12 months or until diagnostic resolution ]
   Stage Shift in NODs with Pancreatic Cancer in subjects that have undergone Pancreatic Cancer Signal Detection testing vs subjects without Pancreatic Cancer Signal Detection testing

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Anna Bergamaschi, PhD; 650-714-9212; abergamaschi@bluestargenomics.com

Contact: Melissa Peters, MA; mpeters@bluestargenomics.com

Locations

United States, Arizona

Headlands Research - Scottsdale - PPDS; Recruiting

Scottsdale, Arizona, United States, 85260-6411

Principal Investigator: Matthew Douglas, MD

United States, Florida

JEM Research Institute - Headlands - PPDS; Recruiting

Atlantis, Florida, United States, 33462-6631

Principal Investigator: David Halpert, MD

United States, South Carolina

Prisma Health/Endocrinology specialist and Thyroid; Recruiting

Greenville, South Carolina, United States, 29605-4289

Principal Investigator: Sandra Weber, MD

United States, Texas

Consano Clinical Research, LLC; Recruiting

Shavano Park, Texas, United States, 78231-1281

Principal Investigator: Michelle Welch, MD

United States, Virginia

Manassas Clinical Research Center; Recruiting

Manassas, Virginia, United States, 20110-4421

Principal Investigator: Nabil Andrawis, MD

Sponsors and Collaborators

ClearNote Health

Investigators

• Principal Investigator: Kelly Bethel, MD; Bluestar Genomics

More Information

• Responsible Party: ClearNote Health
• ClinicalTrials.gov Identifier: NCT05188586
• Other Study ID Numbers: NODMED
• First Posted: January 12, 2022
• Last Update Posted: December 8, 2022
• Last Verified: December 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ClearNote Health:

Early Detection; New Onset Diabetes

Additional relevant MeSH terms:

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