Clinical trial NCT05188586: New Onset Diabetes Management for Earlier Detection of Pancreatic Cancer (NODMED)
Official title: New Onset Diabetes Management for Earlier Detection of Pancreatic Cancer (NODMED)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pancreatic Cancer
Keywords: Early Detection
New Onset Diabetes
Lead sponsor: ClearNote Health
Sponsor class: INDUSTRY
First posted: 2022-01-12
Enrollment: 26
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SCREENING

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.

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.

Eligibility 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

Primary outcomes:
measure: Positive Predictive Value (PPV)
timeFrame: 12 months or until diagnostic resolution
measure: Negative Predictive Value (NPV)
timeFrame: 12 months or until diagnostic resolution
measure: Specificity
timeFrame: 12 months or until diagnostic resolution
Secondary outcomes:
measure: Time to pancreatic cancer diagnosis
timeFrame: 12 months or until diagnostic resolution
measure: Stage Shift
timeFrame: 12 months or until diagnostic resolution
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Headlands Research - Scottsdale - PPDS
state: Arizona
city: Atlantis
country: United States
facility: JEM Research Institute - Headlands - PPDS
state: Florida
city: Greenville
country: United States
facility: Prisma Health/Endocrinology specialist and Thyroid
state: South Carolina
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
Study officials:
affiliation: ClearNote Health
name: Samuel Levy, PhD
role: PRINCIPAL_INVESTIGATOR
References: