EpiDetect Study: Clinical Validation Of A Pancreatic Cancer Detection Test In New-Onset Diabetes Patients

Study Overview

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 ⋞tected" 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.

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 ⋞tected", 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 ⋞tected" and will undergo MRI imaging.

Pancreatic Cancer

DEVICE: Early detection pancreatic cancer test
DEVICE: Early detection pancreatic cancer test and MRI Imaging

EpiDetect

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-12-27	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-12-27
First Submitted that Met QC Criteria 2021-12-27	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-01-12
First Posted (ACTUAL) 2022-01-12	Results First Posted N/A	Last Verified 2021-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Screening

Allocation:
Randomized

Interventional Model:
Sequential

Masking:
None

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 a	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=20	DEVICE: Early detection pancreatic cancer test and MRI Imaging Blood collection and pancreatic cancer early detection testing with return of results and MRI Imaging

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 a

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=20

DEVICE: Early detection pancreatic cancer test and MRI Imaging

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

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Anna Bergamaschi, PhD

Phone Number: 650-714-9212

Email: [email protected]

Study Contact Backup

Name: Judy Sheard, MPH, CCRA

Phone Number: 858-342-4493

Email: [email protected]

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
50 Years

Accepts Healthy Volunteers:

≥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)

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Kelly Bethel, MD, Bluestar Genomics

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record