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• W4387248894 abstract "SESSION TITLE: Lung Cancer Posters 3 SESSION TYPE: Original Investigation Posters PRESENTED ON: 10/10/2023 12:00 pm - 12:45 pm PURPOSE: Risk assessment of pulmonary nodules (PN) can be challenging due to their diverse characteristics and potential for malignancy. A blood-based integrated classifier (IC) designed to rule-out benign conditions has been demonstrated to reduce the rates of unnecessary invasive diagnostic procedures. The performance of this biomarker across nodule densities has not been defined, therefore the purpose of this exploratory analysis is to determine if use of the IC can lead to a reduction in invasive procedures on benign PNs across nodule densities (solid, part solid, and ground glass opacity [GGO]) as compared to an untested control population. METHODS: ORACLE (NCT03766958) is a multicenter observational study designed to evaluate the impact of an IC on physician decision-making when used in the clinical management of a recently identified PNs with a probability of cancer (pCA) ≤50% by Mayo SPN, age >40, 8-30mm in diameter and no history of lung cancer or other cancer within 5 years. A total 280 IC Tested and 278 control patients met the intended use criteria. To ensure comparability between the two groups, they were propensity score matched (PSM), resulting in two groups of equal size (n=197 each) and cancer prevalence (18%). Outcomes were based on biopsy proven cancer or CT stability/resolution at ≥12 months of follow up. RESULTS: The proportions of nodule densities in the PSM groups were: 67% and 66% solid (p=0.2); 15% and 13% part-solid (p=0.2); 17% and 21% GGO (p=0.7) for the IC Tested and control groups, respectively. Furthermore, the clinical characteristics and cancer prevalence among the IC tested and control PN density groups were balanced and did not differ significantly, except for smoking status in the GGOs. Evaluation of the rate of invasive procedures on benign PNs by nodule type demonstrated a significant reduction in invasive procedures in the IC tested group compared to the control group across all nodule density categories. In the overall PSM groups, there was a -14% absolute reduction (8/162 vs. 30/161, p=<0.001) in invasive procedures on benign nodules between the IC Tested and control groups, respectively. When assessed by PN density, the absolute reduction was -9.7% (7/109 vs. 16/99, p=0.044) for solid PNs, -17% for part-solid PNs (1/23 vs. 5/23, p=0.2), and -23% for GGO PNs (0/30 vs. 9/39, p=0.014). CONCLUSIONS: The use of a blood-based IC biomarker can lead to a reduction in unnecessary invasive procedures on benign PNs regardless of density. These results suggest that the IC can change physician decision-making and reduce unnecessary invasive procedures on benign PNs. CLINICAL IMPLICATIONS: The use of a biomarker to rule out low-to-intermediate probability pulmonary nodules can reduce the number of unnecessary procedures in benign nodules, and this clinical benefit is consistent across nodule types. DISCLOSURES: No disclosure on file for Mark Bowling Speaker/Speaker's Bureau relationship with Biodesix Please note: 2018 - present by Jonathan Kurman, value=Honoraria Consultant relationship with Pentax Please note: 2022-present Added 12/03/2022 by Jonathan Kurman, source=Web Response, value=Consulting fee Consultant relationship with Novascan Please note: 2022-present Added 12/03/2022 by Jonathan Kurman, source=Web Response, value=Consulting fee Consultant relationship with Merit Please note: 2022-present Added 12/03/2022 by Jonathan Kurman, source=Web Response, value=Consulting fee Consultant relationship with Explorer Surgical Please note: 2022-present Added 03/30/2023 by Jonathan Kurman, source=Web Response, value=Honoraria Speaker/Speaker's Bureau relationship with Veracyte Please note: 2021-present by Jonathan Kurman, value=Honoraria Consultant relationship with Ambu Please note: 2022-present by Jonathan Kurman, value=Consulting fee Consultant relationship with Pulmonx Please note: 2020 - present by Jonathan Kurman, value=Consulting fee Speaker/Speaker's Bureau relationship with Erbe Please note: 2021 - present by Jonathan Kurman, value=Honoraria Consultant relationship with Cook Medical Please note: 2021 - present by Jonathan Kurman, value=Consulting fee Consultant relationship with Boston Scientific Please note: 2021 - present by Jonathan Kurman, value=Consulting fee Consultant relationship with Pinnacle Biologics Please note: 2020 - present by Jonathan Kurman, value=Consulting fee Consultant relationship with Medtronic Please note: 2020 - present by Jonathan Kurman, value=Consulting fee Consultant relationship with Level Ex Please note: 2018 - present by Jonathan Kurman, value=Consulting fee Speaker relationship with Intuitive Please note: Since December 2019 by Michael Pritchett, value=Consulting fee Consultant relationship with Medtronic Please note: Since 2014 by Michael Pritchett, value=Consulting fee Consultant relationship with Johnson&Johnson Please note: Since December 2018 by Michael Pritchett, value=Consulting fee Consultant relationship with Philips Please note: Since 2019 by Michael Pritchett, value=Consulting fee" @default.
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• W4387248894 date "2023-10-01" @default.
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• W4387248894 title "REAL-WORLD IMPACT OF A BLOOD-BASED INTEGRATED CLASSIFIER ON THE MANAGEMENT OF BENIGN SOLID, PART-SOLID, AND GROUND GLASS PULMONARY NODULES" @default.
• W4387248894 doi "https://doi.org/10.1016/j.chest.2023.07.2713" @default.
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