Observational studyPloS one2023
Assessing a biomarker's ability to reduce invasive procedures in patients with benign lung nodules: Results from the ORACLE study.
Observational study in PloS one, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03766958 (An Observational Registry Study to Evaluate the Performance of the BDX-XL2 Test), which is not on this map. Cited by 7 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Observational Registry Study to Evaluate the Performance of the BDX-XL2 Test
Who cites it
7 citing papers in PubMed.
- Biomarkers for Lung Nodule Risk Stratification: Are We There Yet?Diagnostics (Basel, Switzerland) · 2026Review
- Validation of a blood-based autoantibody test to assess lung cancer risk in 4-30 mm pulmonary nodules: a retrospective pooled analysis of four cohort studies.Future oncology (London, England) · 2026Article
- Article
- Biomarkers for the diagnosis of indeterminate pulmonary nodules: are we there yet?Journal of thoracic disease · 2025Review
- An integrated proteomic classifier to distinguish benign from malignant pulmonary nodules.Clinical proteomics · 2025Article
- Validation of a High-Specificity Blood Autoantibody Test to Detect Lung Cancer in Pulmonary Nodules.CHEST pulmonary · 2025Article
- Biomarkers in lung cancer diagnosis and bronchoscopy: Current landscape and future directions.Cancer biomarkers : section A of Disease markers · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
A blood-based integrated classifier (IC) has been clinically validated to improve accuracy in assessing probability of cancer risk (pCA) for pulmonary nodules (PN). This study evaluated the clinical utility of this biomarker for its ability to reduce invasive procedures in patients with pre-test pCA ≤ 50%. This was a propensity score matching (PSM) cohort study comparing patients in the ORACLE prospective, multicenter, observational registry to control patients treated with usual care. This study enrolled patients meeting the intended use criteria for IC testing: pCA ≤ 50%, age ≥40 years, nodule diameter 8-30 mm, and no history of lung cancer and/or active cancer (except for non-melanomatous skin cancer) within 5 years. The primary aim of this study was to evaluate invasive procedure use on benign PNs of registry patients as compared to control patients. A total of 280 IC tested, and 278 control patients met eligibility and analysis criteria and 197 were in each group after PSM (IC and control groups). Patients in the IC group were 74% less likely to undergo an invasive procedure as compared to the control group (absolute difference 14%, p <0.001) indicating that for every 7 patients tested, one unnecessary invasive procedure was avoided. Invasive procedure reduction corresponded to a reduction in risk classification, with 71 patients (36%) in the IC group classified as low risk (pCA < 5%). The proportion of IC group patients with malignant PNs sent to surveillance were not statistically different than the control group, 7.5% vs 3.5% for the IC vs. control groups, respectively (absolute difference 3.91%, p 0.075). The IC for patients with a newly discovered PN has demonstrated valuable clinical utility in a real-world setting. Use of this biomarker can change physicians' practice and reduce invasive procedures in patients with benign pulmonary nodules. Trial registration: Clinical trial registration: ClinicalTrials.gov NCT03766958.
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