Pancreatic CancerNCT05188573
EpiDetect Study: Clinical Validation of a Pancreatic Cancer Detection Test in New-Onset Diabetes Patients
A study testing Early detection pancreatic cancer test and Early detection pancreatic cancer test and MRI Imaging in people with Pancreatic Cancer, run by ClearNote Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Early detection pancreatic cancer test and Early detection pancreatic cancer test and MRI Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Show all 12Show fewer
- 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)
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Bluestar Genomics, Inc.
San Diego, California, 92121
About this study
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.
Read the 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.
- Conditions
- Pancreatic Cancer
- Being tested
- Early detection pancreatic cancer test, Early detection pancreatic cancer test and MRI Imaging
- Keywords
- Pancreatic cancer; Early pancreatic cancer detection
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early detection pancreatic cancer testDevice
Blood collection and pancreatic cancer early detection testing with return of results
Early detection pancreatic cancer test and MRI ImagingDevice
Blood collection and pancreatic cancer early detection testing with return of results and MRI Imaging
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Early detection pancreatic cancer test and MRI Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance of test: pancreatic cancer sensitivity
Test sensitivity (Sn) for histopathology confirmed pancreatic cancer (ground truth)
Measured: 24 months or until diagnostic resolution
Clinical performance of test: IPMNs sensitivity
Test sensitivity (Sn) for intraductal papillary mucinous neoplasms (IPMNs)
Measured: 24 months or until diagnostic resolution
Clinical performance of test: Specificity
Test specificity (Sp) for pancreatic neoplasia.
Measured: 24 months or until diagnostic resolution
Secondary outcomes (3)
Positive Predictive Value
PPV for pancreatic neoplasia
Measured: 24 months or until diagnostic resolution
Negative Predictive Value
NPV
Measured: 24 months or until diagnostic resolution
Stage Shift
Evaluation of stage at diagnosis
Measured: 24 months or until diagnostic resolution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start1 Jun 2022 (estimated)
- Primary completion31 Mar 2025 (estimated)
- Study completion31 May 2025 (estimated)
Why it stopped: Study not initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ClearNote Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kelly Bethel, MD, Principal investigator, Bluestar Genomics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188573
- Sponsor's protocol ID
- EpiDetect
- Status last verified
- Mar 2026
- First submitted
- 27 Dec 2021
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EpiDetect Study: Clinical Validation of a Pancreatic Cancer Detection Test in New-Onset Diabetes Patients
- ClinicalTrials.gov ID
- NCT05188573
- Acronym / sponsor ID
- EpiDetect
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic cancer; Early pancreatic cancer detection
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ClearNote HealthIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EpiDetect Arm | Experimental | Device: Early detection pancreatic cancer testEach 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. |
| EpiDetect "not detected" MRI Arm | Experimental | Device: Early detection pancreatic cancer test and MRI ImagingA 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- ≥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%
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early detection pancreatic cancer testBlood collection and pancreatic cancer early detection testing with return of results | Device | EpiDetect Arm |
| Early detection pancreatic cancer test and MRI ImagingBlood collection and pancreatic cancer early detection testing with return of results and MRI Imaging | Device | EpiDetect "not detected" MRI Arm |
Primary outcome
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)
Clinical performance of test: IPMNs sensitivity
Time frame: 24 months or until diagnostic resolution
Test sensitivity (Sn) for intraductal papillary mucinous neoplasms (IPMNs)
Clinical performance of test: Specificity
Time frame: 24 months or until diagnostic resolution
Test specificity (Sp) for pancreatic neoplasia.
3 secondary outcomes
Positive Predictive Value
Time frame: 24 months or until diagnostic resolution
Negative Predictive Value
Time frame: 24 months or until diagnostic resolution
Stage Shift
Time frame: 24 months or until diagnostic resolution
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly Bethel, MD principal investigator
Bluestar Genomics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early detection pancreatic cancer test and Early detection pancreatic cancer test and MRI Imaging in people with Pancreatic Cancer, run by ClearNote Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical performance of test: pancreatic cancer sensitivity (time frame: 24 months or until diagnostic resolution). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.