Gastro-Intestinal DisorderNCT05200325
Clinical Utility Evidence for TissueCypher®
A study testing Educational materials for TissueCypher in people with Gastro-Intestinal Disorder and Barrett Esophagus, run by Qure Healthcare, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastro-Intestinal Disorder, Barrett Esophagus
- What is being tested?
- Educational materials for TissueCypher
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2021to 15 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Gastro-Intestinal Disorder, Barrett Esophagus
- Being tested
- Educational materials for TissueCypher
- Medical subject headings
- Digestive System Diseases, Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational materials for TissueCypherOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Educational materials for TissueCypher |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.)
Measured: 1 month
Secondary outcomes (2)
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
Measured: 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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start6 Jun 2021
- Primary completion15 Dec 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastro-Intestinal DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qure Healthcare, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200325
- Sponsor's protocol ID
- Pro00056136
- Status last verified
- Nov 2023
- First submitted
- 9 Dec 2021
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37767993
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Clinical Utility Evidence to Support Coverage and Reimbursement for TissueCypher®: A CPV® Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05200325
- Acronym / sponsor ID
- Pro00056136
- Conditions
- Gastro-Intestinal Disorder, Barrett Esophagus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Qure Healthcare, LLCIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Educational materials for TissueCypherIntervention 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. |
| Intervention Group 2 | Experimental | Other: Educational materials for TissueCypherIntervention 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational materials for TissueCypherThese materials detail what the test does, how it is used, the validity and specifications of the test, and how to read its test report. | Other | Intervention Group 1, Intervention Group 2 |
Primary outcome
Clinical Performance and Value (CPV)-measured change in physician behavior
Time frame: 4 months
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.
CPV-measured evidence based management decisions
Time frame: 4 months
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.
CPV-measured cost savings
Time frame: 1 month
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.)
2 secondary outcomes
CPV-measured baseline levels of variation
Time frame: 4 months
CPV-measured use case analysis
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Derived from this study: PubMed 37767993Peabody 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational materials for TissueCypher in people with Gastro-Intestinal Disorder and Barrett Esophagus, run by Qure Healthcare, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Performance and Value (CPV)-measured change in physician behavior (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05200325, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.