Establishing Clinical Utility Evidence to Support Coverage and Reimbursement for Venn Biosciences' Dawn Test

NCT05603299 | Withdrawn

• 1 other identifier: Pro00062590
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

QURE will use its CPV technology in a randomized controlled trial to measure how InterVenn Biosciences diagnostic test changes clinical practice and improves patient outcomes.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• CPV-measured clinical score difference

  Pre- and post-difference in the overall and the diagnostic and treatment quality scores between control physicians using standard of care diagnostic tools and intervention physicians using the Dawn™ test. In each CPV, participants' care recommendations are evaluated against evidence-based care scoring criteria which can sum from 0 to a high potential score of up to 100 percent in each domain, where higher scores mean better outcomes. The investigators will measure the overall change in the evidence-based physician behavior including physical exam, workup, diagnosis, and treatment of lung cancer in the CPV patient simulations.

  [6 months]

• CPV-measured cost difference

  Change in cost of related care for patients with lung cancer when comparing the control to the intervention group. (This cost is modeled in part by measuring differential rates of medical interventions selected by each arm and multiplying by average Medicare reimbursement rates for these interventions. The cost is also modeled by examining average per annum costs for patients suffering from lung cancer and multiplying by the percent of patients whose workup and interventions for cancer risks are significantly reduced following the intervention.)

  [6 months]

Secondary Outcomes (2)

• CPV-measured baseline clinical variation levels

  [6 months]

• CPV-measured assessment of use case types

  [6 months]

Study Arms (3)

Control Group

NO INTERVENTION

The Control group treats their simulated patients using standard practice and have no introduction to the new test.

Intervention Group 1 - Test Results Given

EXPERIMENTAL

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.

Other: Educational Materials on the Dawn test

Intervention Group 2 - Test Results Optional

EXPERIMENTAL

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.

Other: Educational Materials on the Dawn test

Interventions

Educational Materials on the Dawn test OTHER

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 1 - Test Results Given; Intervention Group 2 - Test Results Optional

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Board-certified medical oncologists 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 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

You may not qualify if:

• Not board-certified in oncology
• 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

Sponsors & Collaborators

• Qure Healthcare, LLC: lead
• Venn Biosciences Corporation: collaborator

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• John W Peabody, MD, PhD

  QURE Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 2, 2022
• Study Start: June 21, 2023
• Primary Completion: December 18, 2023
• Study Completion: December 18, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06