Pancreas CancerNCT05702385
Clinical Utility Study for Exo-PDAC
A study testing Educational Materials for a new diagnostic test in people with Pancreas Cancer, run by Qure Healthcare, LLC at 1 site in United States.
Trial summary
This is a national-level research study of oncologists, interventional gastroenterologists, and primary care providers. The purpose of this study is to assess the clinical evaluation and management (drug, procedures, counseling and other) of a subset of common patient care indications. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- Educational Materials for a new diagnostic test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 31 Oct 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Board-certified for at least two years
- Averaging at least 20 hours per week of clinical and patient care duties over the last six months
- Routinely evaluate patients at risk for pancreatic cancer in their practice
- Practicing in the U.S.
- English speaking
- Access to the internet
- Informed, signed, and voluntarily consented to be in the study
Who cannot join
- Non-English speaking
- Unable to access the internet
- Not practicing in the U.S.
- Not averaging at least 20 hours per week of clinical or patient care duties over the last six months
- Previous exposure to the test
- Do not voluntarily consent to be in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Establishing Clinical Utility Evidence to Support Coverage and Reimbursement for Biological Dynamic's Exo-PDAC Test: A CPV® Randomized Controlled Trial
This is a national-level research study of oncologists, interventional gastroenterologists, and primary care providers. The purpose of this study is to assess the clinical evaluation and management (drug, procedures, counseling and other) of a subset of common patient care indications.
Read the detailed description
The results of this study could contribute to improved quality of care for patients by encouraging better care practices and adherence to evidence-based guidance. The data from this study will be submitted to a national journal for publication. The study plans to enroll up to 250 physicians.
Upon consenting and agreeing to participate in this study, participants will be asked to care for 3 simulated patient cases, known as Clinical Performance and Value Vignettes (CPV®). CPV®s describe patients physicians typically encounter in their daily practice and are not meant to be difficult. In each vignette, physicians are asked to share their expected care through 5 domains: 1) history, 2) physical exam, 3) diagnostic workup, 4) diagnosis and 5) treatment and follow-up. Each case takes approximately 15-20 minutes to complete and we estimate the time commitment for each round of CPV® administration to be approximately 45 - 60 minutes. All responses to the cases will be completed online and will be kept confidential. Over 2 CPV® administration rounds, the total time to care for the simulated patients is estimated at 1.5-2 hours.
If physicians are randomized to an intervention group in this study, they will receive educational materials on a novel diagnostic test after the first round of CPV® administration. They are asked to review these materials before moving to the next CPV® administration round. The time to review educational materials is estimated to be approximately 15 minutes.
- Conditions
- Pancreas Cancer
- Being tested
- Educational Materials for a new diagnostic test
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Materials for a new diagnostic testOther
These materials detail what the test does, how it is used, the validity and specifications of the test, and how to read its test report.
| Study group | Role | What they receive |
|---|---|---|
| Standard Practice | No intervention | The control group treats their simulated patients using standard practice and has no introduction to the new diagnostic test. |
| Intervention Group 1 - Test Results Given | Experimental | Intervention Group 1 will receive information regarding the test and will be given the test results, whether selected or not, in Round 2 of CPV administration. Receives: Other: Educational Materials for a new diagnostic test |
| Intervention Group 2 - Test Results Optional | Experimental | Intervention Group 2 will receive information regarding the test and will be given the test results if selected in Round 2 of CPV administration. Receives: Other: Educational Materials for a new diagnostic test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Performance and Value (CPV)-measured variation in Assessment
Measure variation in the number and quality of clinical decisions among practicing oncologists, primary care physicians, and interventional gastroenterologists in the assessment, surveillance, and management of patients at high risk of developing PDAC. The number and quality of clinical decisions will be measured on a scale of 0-100 where higher numbers represent closer adherence to evidence base national guidelines.
Measured: [4 months]
CPV-measured change in treatment Quality
Measure of the difference in quality of overall diagnostic scores between control physicians using standard of care diagnostic tools and intervention physicians using the diagnostic test.
Measured: [4 months]
CPV-measured variation in evidence based decisions between control and intervention arms
Measure of the difference in number of evidence-based decisions made by intervention physicians versus control physicians, while controlling for physician and practice characteristics, between rounds 1 and 2.
Measured: [4 months]
CPV-measured variation in evidence based decisions between intervention arms
Measure the differences in amount of evidence-based decisions made by intervention group one physicians versus intervention group two physicians to assess whether the choice to order the test impacts the overall patient care and outcomes.
Measured: [4 months]
CPV-measured rate of adoption for the diagnostic test
Rate of adoption of the test after receiving educational materials on the benefits of testing in patients who are at risk.
Measured: [4 months]
CPV-measured differences in cost of care between control and intervention arms
Difference in the cost of care between control and intervention physicians (Cost will be calculated by measuring differential rates of medical interventions/levels of care selected by each arm, and multiplying by Medicare reimbursement rates for these interventions, and/or by modeling the incidence of expected complications and calculating associated costs per above).
Measured: [4 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start1 Sep 2023
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Why it stopped: The study sponsor did not wish to proceed with the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will enroll oncologists, interventional gastroenterologists, and primary care providers practicing in the US. Participants are randomly assigned to either control, intervention 1, or intervention 2 arms upon enrollment. All eligible and consented participants will complete two rounds of three patient simulations. Intervention 1 and intervention 2 arms only will receive educational material about the diagnostic test in between these two rounds. Intervention 1 arm participants only will receive the test results whether they select it or not, and Intervention 2 participants will receive the test results only if they select it in the second round of simulated cases
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qure Healthcare, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702385
- Sponsor's protocol ID
- Pro00068105
- Status last verified
- Nov 2023
- First submitted
- 18 Jan 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Clinical Utility Evidence to Support Coverage and Reimbursement for Biological Dynamic's Exo-PDAC Test: A CPV® Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05702385
- Acronym / sponsor ID
- Pro00068105
- Conditions
- Pancreas Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study sponsor did not wish to proceed with the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Qure Healthcare, LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 27 Jan 2023 (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.
This is a national-level research study of oncologists, interventional gastroenterologists, and primary care providers. The purpose of this study is to assess the clinical evaluation and management (drug, procedures, counseling and other) of a subset of common patient care indications.
Detailed description
The results of this study could contribute to improved quality of care for patients by encouraging better care practices and adherence to evidence-based guidance. The data from this study will be submitted to a national journal for publication. The study plans to enroll up to 250 physicians.
Upon consenting and agreeing to participate in this study, participants will be asked to care for 3 simulated patient cases, known as Clinical Performance and Value Vignettes (CPV®). CPV®s describe patients physicians typically encounter in their daily practice and are not meant to be difficult. In each vignette, physicians are asked to share their expected care through 5 domains: 1) history, 2) physical exam, 3) diagnostic workup, 4) diagnosis and 5) treatment and follow-up. Each case takes approximately 15-20 minutes to complete and we estimate the time commitment for each round of CPV® administration to be approximately 45 - 60 minutes. All responses to the cases will be completed online and will be kept confidential. Over 2 CPV® administration rounds, the total time to care for the simulated patients is estimated at 1.5-2 hours.
If physicians are randomized to an intervention group in this study, they will receive educational materials on a novel diagnostic test after the first round of CPV® administration. They are asked to review these materials before moving to the next CPV® administration round. The time to review educational materials is estimated to be approximately 15 minutes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study will enroll oncologists, interventional gastroenterologists, and primary care providers practicing in the US. Participants are randomly assigned to either control, intervention 1, or intervention 2 arms upon enrollment. All eligible and consented participants will complete two rounds of three patient simulations. Intervention 1 and intervention 2 arms only will receive educational material about the diagnostic test in between these two rounds. Intervention 1 arm participants only will receive the test results whether they select it or not, and Intervention 2 participants will receive the test results only if they select it in the second round of simulated cases
| Arm | Type | Receives |
|---|---|---|
| Standard Practice | No intervention | –The control group treats their simulated patients using standard practice and has no introduction to the new diagnostic test. |
| Intervention Group 1 - Test Results Given | Experimental | Other: Educational Materials for a new diagnostic testIntervention Group 1 will receive information regarding the test and will be given the test results, whether selected or not, in Round 2 of CPV administration. |
| Intervention Group 2 - Test Results Optional | Experimental | Other: Educational Materials for a new diagnostic testIntervention Group 2 will receive information regarding the test and will be given the test results if selected in Round 2 of CPV administration. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Board-certified for at least two years
- Averaging at least 20 hours per week of clinical and patient care duties over the last six months
- Routinely evaluate patients at risk for pancreatic cancer in their practice
- Practicing in the U.S.
- English speaking
Key exclusion criteria (6 listed)
- Non-English speaking
- Unable to access the internet
- Not practicing in the U.S.
- Not averaging at least 20 hours per week of clinical or patient care duties over the last six months
- Previous exposure to the test
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 |
|---|---|---|
| Educational Materials for a new diagnostic testThese materials detail what the test does, how it is used, the validity and specifications of the test, and how to read its test report. | Other | Intervention Group 1 - Test Results Given, Intervention Group 2 - Test Results Optional |
Primary outcome
Clinical Performance and Value (CPV)-measured variation in Assessment
Time frame: [4 months]
Measure variation in the number and quality of clinical decisions among practicing oncologists, primary care physicians, and interventional gastroenterologists in the assessment, surveillance, and management of patients at high risk of developing PDAC. The number and quality of clinical decisions will be measured on a scale of 0-100 where higher numbers represent closer adherence to evidence base national guidelines.
CPV-measured change in treatment Quality
Time frame: [4 months]
Measure of the difference in quality of overall diagnostic scores between control physicians using standard of care diagnostic tools and intervention physicians using the diagnostic test.
CPV-measured variation in evidence based decisions between control and intervention arms
Time frame: [4 months]
Measure of the difference in number of evidence-based decisions made by intervention physicians versus control physicians, while controlling for physician and practice characteristics, between rounds 1 and 2.
CPV-measured variation in evidence based decisions between intervention arms
Time frame: [4 months]
Measure the differences in amount of evidence-based decisions made by intervention group one physicians versus intervention group two physicians to assess whether the choice to order the test impacts the overall patient care and outcomes.
CPV-measured rate of adoption for the diagnostic test
Time frame: [4 months]
Rate of adoption of the test after receiving educational materials on the benefits of testing in patients who are at risk.
CPV-measured differences in cost of care between control and intervention arms
Time frame: [4 months]
Difference in the cost of care between control and intervention physicians (Cost will be calculated by measuring differential rates of medical interventions/levels of care selected by each arm, and multiplying by Medicare reimbursement rates for these interventions, and/or by modeling the incidence of expected complications and calculating associated costs per above).
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 7 Dec 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Materials for a new diagnostic test in people with Pancreas Cancer, run by Qure Healthcare, LLC 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 7 inclusion and 6 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 7 Dec 2023. 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 and Value (CPV)-measured variation in Assessment (time frame: [4 months]). The study lists 6 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 7 Dec 2023.