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| Name | Class |
|---|---|
| Optellum Ltd. | UNKNOWN |
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This study is a multi-centre prospective observational cohort study recruiting patients with 5-30mm solid and part-solid pulmonary nodules that have been detected on CT chest scans performed as part of routine practice. The aim is to determine whether physician decision making with the AI-based LCP tool, generates clinical and health-economic benefits over the current standard of care of these patients.
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| Measure | Description | Time Frame |
|---|---|---|
| Determine the potential effect of the LCP on discharge | Measured difference between standard care, LCP and LCP-guided care for:
| up to 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the potential effect of the LCP on overall clinical management, as well as scan and procedure utilization. | Percentage of cancer patients for whom there would have been a change in clinical management by LCP and LCP-guided care compared with the actual (standard) care (correctly by more aggressive management and incorrectly for less aggressive management). Percentage of benign-nodule patients for whom there would have been a change in clinical management by LCP and LCP-guided care compared with the actual (standard) care (incorrectly by more aggressive management and correctly for less aggressive management). Measured difference between standard care, LCP and LCP-guided care for:
|
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Inclusion Criteria:
Patients are eligible for the study if all of the following apply:
Are aged 35 years or above
Have baseline CT study with at least one incidentally detected solid or part-solid (must have a solid component >=80%) pulmonary nodule that:
Have baseline CT study that includes at least one series that meets all of the following (training for this will be provided):
Exclusion Criteria:
Patients will be excluded from the study if any of the following apply:
Have received a diagnosis for cancer in the last 5 years
Have thoracic implants that impact the image appearance of the nodule
Have more than five reported pulmonary nodules of any size or type excluding fully calcified nodules (this criterion is used as a proxy due to the risk of being an infection or metastasis)
Have one or more additional nodules where any of the following applies:
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The CT scans of patients for whom a pulmonary nodule has been identified will be reviewed for study eligibility by a member of the local site's clinical team for the patient.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Betsi Cadwaladr University Health Board | Recruiting | Bangor | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38176863 | Derived | O'Dowd E, Berovic M, Callister M, Chalitsios CV, Chopra D, Das I, Draper A, Garner JL, Gleeson F, Janes S, Kennedy M, Lee R, Mauri F, McKeever TM, McNulty W, Murray J, Nair A, Park J, Rawlinson J, Sagoo GS, Scarsbrook A, Shah P, Sudhir R, Talwar A, Thakrar R, Watkins J, Baldwin DR. Determining the impact of an artificial intelligence tool on the management of pulmonary nodules detected incidentally on CT (DOLCE) study protocol: a prospective, non-interventional multicentre UK study. BMJ Open. 2024 Jan 4;14(1):e077747. doi: 10.1136/bmjopen-2023-077747. |
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| up to 1 year. |
| Determine the potential effect of the hypothetical LCP-informed care versus standard care on patient outcomes. | Measured difference between standard care, LCP and LCP-guided care for:
| up to 1 year. |
| Determine the potential health-economic effect of the hypothetical LCP-informed care versus standard care | Measured difference between standard care, LCP and LCP-guided care for:
| up to 1 year. |
| Determine the potential effect of the LCP on possible adherence to clinical guidelines. | Measured difference between standard care and LCP-guided care for : Number and percentage of patients for whom a validated risk model (Brock or LCP) is used to guide the next clinical management step (i.e., counting the instances where Brock is not used, or where LCP is not possible to compute or it is ignored). | up to 1 year. |
| Frimley Health NHS Foundation Trust (Wexham Park Hospital) | Recruiting | Frimley | United Kingdom |
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| Leeds Teaching Hospitals NHS Trust | Recruiting | Leeds | United Kingdom |
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| King's College Hospital NHS Foundation Trust | Recruiting | London | United Kingdom |
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| Royal Free Hospital | Recruiting | London | United Kingdom |
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| St. George's University Hospitals NHS Foundation Trust | Recruiting | London | United Kingdom |
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| The Royal Marsden NHS Foundation Trust | Recruiting | London | United Kingdom |
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| University College London Hospitals NHS Foundation Trust | Recruiting | London | United Kingdom |
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| Nottingham University Hospitals NHS Trust | Recruiting | Nottingham | United Kingdom |
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| Oxford University Hospitals NHS Foundation Trust | Recruiting | Oxford | United Kingdom |
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| ID | Term |
|---|---|
| D003074 | Solitary Pulmonary Nodule |
| D055613 | Multiple Pulmonary Nodules |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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