Establishing Clinical Utility Evidence to Support Coverage and Reimbursement for Venn Biosciences' Dawn Test
NCT ID: NCT05603299
Last Updated: 2023-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
NA
INTERVENTIONAL
2023-06-21
2023-12-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical Evaluation of a COVID-19 Antigen Self-Test (CoviDx™)
NCT05403346
Validation of Point of Care Liver Function Tests
NCT03800069
Generation of Positive Biological Samples to Epoetin for Doping Control.
NCT02920372
Bias Source of Signal in SCOUT DS
NCT01550328
One Touch VerioIQ US Clinical Outcomes Study
NCT01627899
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
VennBio hopes to make Dawn™'s glycoproteomic solution widely available and is looking to accelerate the adoption of the test in patients with advanced/metastatic NSCLC. To make the test available to more patients, VennBio is looking for established, innovative approaches to gather high-quality prospective clinical utility data quickly. These data will be essential to increase access to the test and to gain coverage and reimbursement.
Accordingly, the proposed study will collect high-quality randomized controlled data from a nationally representative sample of practicing medical oncologists. The primary purposes of this study will be to 1) determine how these physicians currently choose therapy for advanced (i.e., locally advanced, unresectable, or metastatic) NSCLC patients, 2) ascertain if introducing the Dawn™ test will improve clinical decision-making, and 3) observe how the educational materials affect physician uptake of the Dawn™ test and treatment of their patients, particularly in assigning immunotherapy (e.g., IO monotherapy vs combination treatment with chemotherapy). Data from this study will investigate the best use case (type of patient) optimally served by Dawn™ testing (and thus the greatest clinical utility) and what physician characteristics (e.g., age, practice setting, training) and practice characteristics (e.g., multi-specialty, private practice, etc.) are associated with these practice changes.
QURE Healthcare is a team of clinicians and researchers that conducts randomized-controlled trials using Clinical Performance and Value (CPV®) patient simulations to generate high-quality clinical utility evidence. CPVs are QURE's scientifically-validated measurement tool, first described in the Journal of American Medical Association (JAMA) in 2000 and now used in scores of scientific investigations. In this research and derivative peer-reviewed publications, QURE's CPV studies efficiently measure clinical practice patterns among active physicians to determine if there is the value of new technologies to payers.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control Group
The Control group treats their simulated patients using standard practice and have no introduction to the new test.
No interventions assigned to this group
Intervention Group 1 - Test Results Given
Receiving educational materials describing the clinical validation and use cases of a predefined Dawn™ test and is given specific Dawn™ test results in Round 2 of CPV administration, whether they order the test or not.
Educational Materials on the Dawn test
Receive educational materials and sample test results replicating what physicians would receive in the real-world market as they learn about the probability of IO therapy response from the Dawn™ test.
Intervention Group 2 - Test Results Optional
Receiving educational materials describing the clinical validation and use cases of a predefined Dawn™ test and is given specific Dawn™ test results in Round 2 of CPV administration, only if they choose to order the test.
Educational Materials on the Dawn test
Receive educational materials and sample test results replicating what physicians would receive in the real-world market as they learn about the probability of IO therapy response from the Dawn™ test.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Educational Materials on the Dawn test
Receive educational materials and sample test results replicating what physicians would receive in the real-world market as they learn about the probability of IO therapy response from the Dawn™ test.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Averaging at least 20 hours per week of clinical and patient care duties over the last six months
* Routinely evaluate patients with advanced/metastatic NSCLC in their practice
* Prescribe IO therapies for their advanced/metastatic NSCLC patients
* Practice in either an academic, non-academic, or network hospital setting
* Practicing in the U.S.
* English speaking
* Access to the internet
* Informed, signed, and voluntarily consented to be in the study
Exclusion Criteria
* Not English speaking
* Not averaging at least 20 hours per week of clinical and patient care duties over the last six months
* Not practicing in the U.S.
* No access to the internet
* Did not voluntarily consent to be in the study
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Venn Biosciences Corporation
INDUSTRY
Qure Healthcare, LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
John W Peabody, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
QURE Healthcare
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Pro00062590
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.