EpiDetect Study: Clinical Validation of a Pancreatic Cancer Detection Test in New-Onset Diabetes Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Device: Early detection pancreatic cancer test; Device: Early detection pancreatic cancer test and MRI Imaging

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Judy Sheard, MPH, CCRA; Phone Number: 858-342-4493; Email: jsheard@bluestargenomics.com

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121
      • Bluestar Genomics, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: EpiDetect Arm; 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. 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.	Device: Early detection pancreatic cancer test; Blood collection and pancreatic cancer early detection testing with return of results
EXPERIMENTAL: EpiDetect "not detected" MRI Arm; A pre-specified number of cases with test results "not detected" will be randomly selected, gender ratio and age matched to subjects with test results "detected" and will undergo MRI imaging at T0 (n=226), at T1 (n=208 ) at T2 (n=208 ) and 24 months (n=208) from diabetes diagnosis.	Device: Early detection pancreatic cancer test and MRI Imaging; Blood collection and pancreatic cancer early detection testing with return of results and MRI Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical performance of test: pancreatic cancer sensitivity	Test sensitivity (Sn) for histopathology confirmed pancreatic cancer (ground truth)	24 months or until diagnostic resolution
Clinical performance of test: IPMNs sensitivity	Test sensitivity (Sn) for intraductal papillary mucinous neoplasms (IPMNs)	24 months or until diagnostic resolution
Clinical performance of test: Specificity	Test specificity (Sp) for pancreatic neoplasia.	24 months or until diagnostic resolution

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive Predictive Value	PPV for pancreatic neoplasia	24 months or until diagnostic resolution
Negative Predictive Value	NPV	24 months or until diagnostic resolution
Stage Shift	Evaluation of stage at diagnosis	24 months or until diagnostic resolution

Collaborators and Investigators

• Sponsor: ClearNote Health

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2022
• Primary Completion (ANTICIPATED): March 31, 2025
• Study Completion (ANTICIPATED): May 31, 2025

Study Registration Dates

• First Submitted: December 27, 2021
• First Submitted That Met QC Criteria: December 27, 2021
• First Posted (ACTUAL): January 12, 2022

Study Record Updates

• Last Update Posted (ACTUAL): January 12, 2022
• Last Update Submitted That Met QC Criteria: December 27, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Pancreatic cancer; Early pancreatic cancer detection
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: EpiDetect

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No