Clinical Utility Evidence for TissueCypher®

NCT05200325 | Completed

• 1 other identifier: Pro00056136
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastro-Intestinal Disorder; Barrett Esophagus

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• CPV-measured baseline levels of variation

  4 months

• CPV-measured use case analysis

  4 months

Study Arms (3)

Control Group

NO INTERVENTION

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.

Intervention Group 1

EXPERIMENTAL

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

Intervention Group 2

EXPERIMENTAL

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

Interventions

Educational materials for TissueCypher OTHER

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.

Intervention Group 1; Intervention Group 2

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qure Healthcare, LLC: lead

Study Sites (1)

QURE Healthcare

San Francisco, California, 94133, United States

Location

Related Publications (1)

• Peabody JW, Cruz JDC, Ganesan D, Paculdo D, Critchley-Thorne RJ, Wani S, Shaheen NJ. A Randomized Controlled Study on Clinical Adherence to Evidence-Based Guidelines in the Management of Simulated Patients With Barrett's Esophagus and the Clinical Utility of a Tissue Systems Pathology Test: Results From Q-TAB. Clin Transl Gastroenterol. 2024 Jan 1;15(1):e00644. doi: 10.14309/ctg.0000000000000644.

  PMID: 37767993 DERIVED

MeSH Terms

Conditions

Digestive System Diseases; Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants, who are care providers, do not know what study arm they are included in.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: January 20, 2022
• Study Start: June 6, 2021
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: December 4, 2023

Record last verified: 2023-11

Locations

US (1)