Clinical Utility Evidence for TissueCypher®

NCT ID: NCT05200325

Last Updated: 2023-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-06

Study Completion Date

2021-12-15

Brief Summary

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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.

Detailed Description

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Conditions

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Gastro-Intestinal Disorder Barrett Esophagus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Caregivers
Participants, who are care providers, do not know what study arm they are included in.

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Educational materials for TissueCypher

Intervention Type 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 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.

Group Type EXPERIMENTAL

Educational materials for TissueCypher

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qure Healthcare, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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QURE Healthcare

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37767993 (View on PubMed)

Other Identifiers

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Pro00056136

Identifier Type: -

Identifier Source: org_study_id