Clinical trial NCT05188573: EpiDetect Study: Clinical Validation of a Pancreatic Cancer Detection Test in New-Onset Diabetes Patients
Official title: EpiDetect Study: Clinical Validation of a Pancreatic Cancer Detection Test in New-Onset Diabetes Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Cancer
Keywords: Pancreatic cancer; Early pancreatic cancer detection
Lead sponsor: ClearNote Health
Sponsor class: INDUSTRY
First posted: 2022-01-12
Enrollment: 10000
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SCREENING

Brief summary: Bluestar Genomics has developed a non-invasive test that aids in the qualitative 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 validate the performance of Bluestar Genomics early-detection pancreatic cancer test. The study is prospective, longitudinal and interventional; tests will be ordered and results returned to site-investigators. If the assay 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 10,000 newly diagnosed type II 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 10,000 male and female, ≥ 50 years of age and newly diagnosed with type II diabetes (within 90 days prior to enrollment). The study population will target 70% of subjects over 65 years old, 53% males and will target to enroll at least 50% of subjects with a BMI \<32.

Each subject can undergo to up to 3 blood draws; at the time of enrollment (T0), at 6 months (T1) and 12 months (T2) from diabetes diagnosis. If test result is "detected", MRI imaging will be performed to further assess the pancreas. If the MRI 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. After 24 months from diabetes diagnosis, a review of the electronic medical records (EMR) will be performed for all subjects with a "not detected" test result.

The study will also include an Bluestar Genomics's test "not detected" imaging arm (negative control imaging arm) for each time point. Subjects included in the negative imaging arm will be pre-specified and randomly selected among the Bluestar Genomics "not detected" cases gender ratio and age matched to Bluestar Genomics "detected" and will undergo MRI imaging.

Eligibility criteria: Inclusion Criteria:

* ≥50 years of age or older at the time of enrollment
* Willing to provide and 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 without meeting DM criteria
* Must be willing to provide several tubes of blood without endangering health
* No history of pancreatic cancer
* No history of IPMNs, other neoplastic cysts and pancreatitis
* 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 carcinomas)

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
* 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: Clinical performance of test: pancreatic cancer sensitivity
timeFrame: 24 months or until diagnostic resolution
measure: Clinical performance of test: IPMNs sensitivity
timeFrame: 24 months or until diagnostic resolution
measure: Clinical performance of test: Specificity
timeFrame: 24 months or until diagnostic resolution
Secondary outcomes:
measure: Positive Predictive Value
timeFrame: 24 months or until diagnostic resolution
measure: Negative Predictive Value
timeFrame: 24 months or until diagnostic resolution
measure: Stage Shift
timeFrame: 24 months or until diagnostic resolution
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Bluestar Genomics, Inc.
state: California
Study officials:
affiliation: Bluestar Genomics
name: Kelly Bethel, MD
role: PRINCIPAL_INVESTIGATOR
References: