Pancreatic CancerNODMEDNCT05188586
New Onset Diabetes Management for Earlier Detection of Pancreatic Cancer (NODMED)
A study testing MRI/Imaging in people with Pancreatic Cancer, run by ClearNote Health at 5 sites in United States.
Trial summary
Bluestar Genomics has developed a non-invasive test that aids in detection of occult pancreatic cancer in patients with new onset type II diabetes (NOD) who are 50 years old or older. 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?
- MRI/Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 5 sitesUnited States
- Study dates
- 31 Oct 2022to 16 Mar 2023
- 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 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 that did NOT meet DM criteria
- Must be willing to provide several tubes of blood without endangering health
- No history of pancreatic cancer or other known pancreatic neoplasia
- 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 cancers)
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 (aside from diabetes)
- 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
5 sites in 1 country.
5 sites in 1 country
United States5 sites
JEM Research Institute - Headlands - PPDS
Atlantis, Florida, 33462-6631
Prisma Health/Endocrinology specialist and Thyroid
Greenville, South Carolina, 29605-4289
Manassas Clinical Research Center
Manassas, Virginia, 20110-4421
Headlands Research - Scottsdale - PPDS
Scottsdale, Arizona, 85260-6411
Consano Clinical Research, LLC
Shavano Park, Texas, 78231-1281
About this study
Bluestar Genomics has developed a non-invasive test that aids in 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 evaluate the performance of Bluestar Genomics early-detection pancreatic cancer test in a clinical setting. The study is prospective, longitudinal and interventional; tests will be ordered and results returned to site-investigators. If the test 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 6,550 newly diagnosed type 2 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 6,550 male and female, ≥ 50 years of age and newly diagnosed with type II diabetes (within 90 days prior to enrollment). NOD subjects will be assessed for eligibility and consented. Each subject can undergo up to 2 blood draws and electronic medical record search at 12 months from diabetes diagnosis.
The study population will be targeted to enroll a subjects with a BMI < 32. Subjects ≥ 50 years of age will be divided into two cohorts based on age as described below:
Cohort 1 = 65 years old or older Time 0 (T0) = blood draw within 90 days of diabetes diagnosis Time 1 (T1) = blood draw 6 month draw from diabetes diagnosis Time 2 (T2) = 12 months from diabetes diagnosis, no blood draw, only medical record search for all patients for evidence of pancreatic neoplasia developed after T1.
Cohort 2 = 50 - 64 years old Time 0 (T0) = blood draw within 90 days of diabetes diagnosis Time 1 (T1) = blood draw 6 month draw from diabetes diagnosis Time 2 (T2) = 12 months from diabetes diagnosis, no blood draw, only medical record search for all patients for evidence of pancreatic neoplasia developed after T1.
Imaging Strategy MRI imaging (or alternate imaging if subject is unable to undergo MRI) will be performed on subjects whose test result is "detected".
If the 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. If pancreatic cancer or other pancreatic lesion is diagnosed, the diagnostic reports will be collected as part of the study clinical data.
- Conditions
- Pancreatic Cancer
- Being tested
- MRI/Imaging
- Keywords
- Early Detection, New Onset Diabetes
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI/ImagingOther
Blood collection and pancreatic cancer early detection testing with return of results.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic Cancer Signal Detection = Detected | Other | Subjects with test results "detected" will undergo MRI/Imaging Receives: Other: MRI/Imaging |
| Pancreatic Cancer Signal Detection = Not Detected | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Predictive Value (PPV)
defined as the proportion of participants with pancreatic neoplasia diagnosis out of all subjects with pancreatic signal "detected" test result.
Measured: 12 months or until diagnostic resolution
Negative Predictive Value (NPV)
defined as the proportion of participants with no pancreatic neoplasia diagnosis out of all the subjects with pancreatic signal "not detected" test results.
Measured: 12 months or until diagnostic resolution
Specificity
defined as the proportion of participants with pancreatic signal "not detected" results out of all subjects with no pancreatic neoplasia diagnosis.
Measured: 12 months or until diagnostic resolution
Secondary outcomes (2)
Time to pancreatic cancer diagnosis
Median time to pancreatic cancer diagnosis (using Pancreatic Cancer Signal Detection testing) relative to new onset diabetes (NOD) diagnosis compared to Median time to pancreatic cancer diagnosis relative to NOD diagnosis in the absence of Pancreatic Cancer Signal Detection testing, based on published data
Measured: 12 months or until diagnostic resolution
Stage Shift
Stage Shift in NODs with Pancreatic Cancer in subjects that have undergone Pancreatic Cancer Signal Detection testing vs subjects without Pancreatic Cancer Signal Detection testing
Measured: 12 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 start31 Oct 2022
- Primary completion16 Mar 2023
- Study completion16 Mar 2023
Why it stopped: enrollment targets not met
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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- ClearNote Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samuel Levy, PhD, Principal investigator, ClearNote Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188586
- Sponsor's protocol ID
- NODMED
- Acronym
- NODMED
- Status last verified
- Sep 2024
- First submitted
- 27 Dec 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Onset Diabetes Management for Earlier Detection of Pancreatic Cancer (NODMED)
- ClinicalTrials.gov ID
- NCT05188586
- Acronym / sponsor ID
- NODMED / NODMED
- Conditions
- Pancreatic Cancer
- Keywords
- Early Detection, New Onset Diabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: enrollment targets not met
- Enrolment
- 26 participants (actual)
- Lead sponsor
- ClearNote HealthIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 16 Mar 2023 (actual)
- Study completion
- 16 Mar 2023 (actual)
- 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 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 evaluate the performance of Bluestar Genomics early-detection pancreatic cancer test in a clinical setting. The study is prospective, longitudinal and interventional; tests will be ordered and results returned to site-investigators. If the test 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 6,550 newly diagnosed type 2 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 6,550 male and female, ≥ 50 years of age and newly diagnosed with type II diabetes (within 90 days prior to enrollment). NOD subjects will be assessed for eligibility and consented. Each subject can undergo up to 2 blood draws and electronic medical record search at 12 months from diabetes diagnosis.
The study population will be targeted to enroll a subjects with a BMI < 32. Subjects ≥ 50 years of age will be divided into two cohorts based on age as described below:
Cohort 1 = 65 years old or older Time 0 (T0) = blood draw within 90 days of diabetes diagnosis Time 1 (T1) = blood draw 6 month draw from diabetes diagnosis Time 2 (T2) = 12 months from diabetes diagnosis, no blood draw, only medical record search for all patients for evidence of pancreatic neoplasia developed after T1.
Cohort 2 = 50 - 64 years old Time 0 (T0) = blood draw within 90 days of diabetes diagnosis Time 1 (T1) = blood draw 6 month draw from diabetes diagnosis Time 2 (T2) = 12 months from diabetes diagnosis, no blood draw, only medical record search for all patients for evidence of pancreatic neoplasia developed after T1.
Imaging Strategy MRI imaging (or alternate imaging if subject is unable to undergo MRI) will be performed on subjects whose test result is "detected".
If the 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. If pancreatic cancer or other pancreatic lesion is diagnosed, the diagnostic reports will be collected as part of the study clinical data.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pancreatic Cancer Signal Detection = Detected | Other | Other: MRI/ImagingSubjects with test results "detected" will undergo MRI/Imaging |
| Pancreatic Cancer Signal Detection = Not Detected | No intervention | – |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ 50 years of age or older at the time of enrollment
- Willing to 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 that did NOT meet DM criteria
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 (aside from diabetes)
- 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 |
|---|---|---|
| MRI/ImagingBlood collection and pancreatic cancer early detection testing with return of results. | Other | Pancreatic Cancer Signal Detection = Detected |
Primary outcome
Positive Predictive Value (PPV)
Time frame: 12 months or until diagnostic resolution
defined as the proportion of participants with pancreatic neoplasia diagnosis out of all subjects with pancreatic signal "detected" test result.
Negative Predictive Value (NPV)
Time frame: 12 months or until diagnostic resolution
defined as the proportion of participants with no pancreatic neoplasia diagnosis out of all the subjects with pancreatic signal "not detected" test results.
Specificity
Time frame: 12 months or until diagnostic resolution
defined as the proportion of participants with pancreatic signal "not detected" results out of all subjects with no pancreatic neoplasia diagnosis.
2 secondary outcomes
Time to pancreatic cancer diagnosis
Time frame: 12 months or until diagnostic resolution
Stage Shift
Time frame: 12 months or until diagnostic resolution
Results and safety
The study was stopped early (reason given: enrollment targets not met). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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.
Samuel Levy, PhD principal investigator
ClearNote Health
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI/Imaging in people with Pancreatic Cancer, run by ClearNote Health at 5 sites 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 8 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: stopped early, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 stopped early (reason given: enrollment targets not met). Results are not available in the source record.
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?
Positive Predictive Value (PPV) (time frame: 12 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 19 Sep 2024.