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

NCT05188573 | Withdrawn FDA Device

• 1 other identifier: EpiDetect
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

Pancreatic cancer; Early pancreatic cancer detection

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Positive Predictive Value

  24 months or until diagnostic resolution

• Negative Predictive Value

  24 months or until diagnostic resolution

• Stage Shift

  24 months or until diagnostic resolution

Study Arms (2)

EpiDetect Arm

EXPERIMENTAL

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

EpiDetect "not detected" MRI Arm

EXPERIMENTAL

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

Interventions

Early detection pancreatic cancer test DEVICE

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

EpiDetect Arm

Early detection pancreatic cancer test and MRI Imaging DEVICE

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

EpiDetect "not detected" MRI Arm

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 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
• 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)

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
• 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 (1)

Bluestar Genomics, Inc.

San Diego, California, 92121, 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

• Kelly Bethel, MD

  Bluestar Genomics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: 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: June 1, 2022
• Primary Completion: March 31, 2025
• Study Completion: May 31, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)