Clinical Utility Evidence for TissueCypher®

Establishing Clinical Utility Evidence to Support Coverage and Reimbursement for TissueCypher®: A CPV® Randomized Controlled Trial

Cernostics has developed a new diagnostic test, and this study will measure how gastroenterologists and foregut surgeons make diagnostic and treatment decisions when presented with different information in the context of simulated clinical cases. 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 provided to all participating physicians and submitted to a national journal for publication. The study plans to enroll up to 249 physicians.

Study Overview

• Status: Completed
• Conditions: Barrett Esophagus; Gastro-Intestinal Disorder
• Intervention / Treatment: Other: Educational materials for TissueCypher

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94133
      • QURE Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Board-certified gastroenterologist or GI surgeon for at least two years
• Averages at least 20 hours per week of clinical and patient care duties over the last six months
• performs either diagnostic endoscopy, interventional endoscopy, upper GI surgery, or bariatric surgery
• practicing in the US
• english speaking
• access to the internet
• informed and voluntarily consented to be in the study

Exclusion Criteria:

• non-English speaking
• unable to access the internet
• not practicing in the US
• not averaging at least 20 hours per week of clinical or patient care duties over the last six months
• does not perform either diagnostic endoscopy, interventional endoscopy, upper GI surgery, or bariatric surgery
• does not voluntarily consent to be in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; The control group does not receive educational materials about the TissueCypher diagnostic test and will treat their simulated patients with the current standard of care tools.
Experimental: Intervention Group 1; Intervention group 1 receives educational materials about the TissueCypher diagnostic test. 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. This intervention group is then forced to use the test results in treating their simulated patients.	Other: Educational materials for TissueCypher; 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.
Experimental: Intervention Group 2; Intervention group 2 receives educational materials about the TissueCypher diagnostic test. 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. This intervention group then gets to decide whether or not they want to use the TissueCypher test results for their simulated patients.	Other: Educational materials for TissueCypher; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Performance and Value (CPV)-measured change in physician behavior	Change in the overall and the diagnostic and treatment evidence-based quality scores in the CPV patient simulations: difference-in-differences regression analysis between the control and the intervention groups' diagnosis and treatment of risk progression in patients with Barrett's esophagus, as measured by the participants diagnostic and treatment CPV case domain scores. In each domain of a CPV (history, physical exam, workup, diagnosis and treatment), 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.	4 months
CPV-measured evidence based management decisions	Evidence-based management decisions based on patient's TissueCypher® test result: Once the intervention group is exposed to the intervention, education materials on the TissueCypher (a validated diagnostic test for predicting risk progression of BE patients), the scores are measured, on a scale of 0% to 100% from round 1 (pre-exposure) to round 2 (post-exposure) and observe how the evidence-based TissueCypher results influence physicians' management decisions.	4 months
CPV-measured cost savings	Change in cost of BE-related care. (This cost is modeled in part by measuring differential rates of endoscopic work up/interventions/levels of care selected by each arm, and multiplying by average Medicare reimbursement rates for these workups/interventions/levels of care. The cost is also modeled by examining average per annum costs for patients suffering from BE, and multiplying by the percent of patients whose workup or therapeutic management is significantly reduced following the intervention.)	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CPV-measured baseline levels of variation	Participants completing the simulated cases, or CPVs, receive scores, on a scale from 0% to 100%, based upon the quality of care they provide. This measure will assess the baseline levels of variation in the care of pain patients among all participants, including by use case types. Baseline levels of variation will be measured in the surveillance, management and treatment of patients with Barrett's esophagus among all participants	4 months
CPV-measured use case analysis	Difference in the overall, and the diagnostic and treatment quality scores between control and intervention participants. Diagnostic and treatment scores are calculated as the percent correct on CPVs, and the overall score is an average score of the subcategory scores (percent correct). The score is reported on a scale from 0% to 100%. This will be examined for each of the use cases to determine in which case(s) CPV scores most improved.	4 months

Collaborators and Investigators

• Sponsor: Qure Healthcare, LLC

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2021
• Primary Completion (Actual): December 15, 2021
• Study Completion (Actual): December 15, 2021

Study Registration Dates

• First Submitted: December 9, 2021
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Estimated): December 4, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Esophageal Diseases; Precancerous Conditions; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Barrett Esophagus
• Other Study ID Numbers: Pro00056136

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No