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

Withdrawn before enrolling · Not applicable

Conditions studied: Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT05188573

Run by

ClearNote Health

People needed

0

Starts

2022-06-01

Expected to finish

2025-05-31

Last updated by the study team

2026-03-27

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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)

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

Where it is running

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

Full record on ClinicalTrials.gov

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