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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05188573
Recruitment Status : Not yet recruiting
First Posted : January 12, 2022
Last Update Posted : January 12, 2022
Sponsor:
Information provided by (Responsible Party):
ClearNote Health

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Device: Early detection pancreatic cancer test Device: Early detection pancreatic cancer test and MRI Imaging Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10000 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: EpiDetect Study: Clinical Validation of a Pancreatic Cancer Detection Test in New-Onset Diabetes Patients
Estimated Study Start Date : June 1, 2022
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : May 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Clinical performance of test: pancreatic cancer sensitivity [ Time Frame: 24 months or until diagnostic resolution ]
    Test sensitivity (Sn) for histopathology confirmed pancreatic cancer (ground truth)

  2. Clinical performance of test: IPMNs sensitivity [ Time Frame: 24 months or until diagnostic resolution ]
    Test sensitivity (Sn) for intraductal papillary mucinous neoplasms (IPMNs)

  3. Clinical performance of test: Specificity [ Time Frame: 24 months or until diagnostic resolution ]
    Test specificity (Sp) for pancreatic neoplasia.


Secondary Outcome Measures :
  1. Positive Predictive Value [ Time Frame: 24 months or until diagnostic resolution ]
    PPV for pancreatic neoplasia

  2. Negative Predictive Value [ Time Frame: 24 months or until diagnostic resolution ]
    NPV

  3. Stage Shift [ Time Frame: 24 months or until diagnostic resolution ]
    Evaluation of stage at diagnosis


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05188573


Contacts
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Contact: Anna Bergamaschi, PhD 650-714-9212 abergamaschi@bluestargenomics.com
Contact: Judy Sheard, MPH, CCRA 858-342-4493 jsheard@bluestargenomics.com

Locations
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United States, California
Bluestar Genomics, Inc.
San Diego, California, United States, 92121
Sponsors and Collaborators
ClearNote Health
Investigators
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Principal Investigator: Kelly Bethel, MD Bluestar Genomics
More Information
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Responsible Party: ClearNote Health
ClinicalTrials.gov Identifier: NCT05188573    
Other Study ID Numbers: EpiDetect
First Posted: January 12, 2022    Key Record Dates
Last Update Posted: January 12, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by ClearNote Health:
Pancreatic cancer; Early pancreatic cancer detection
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases