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Life sciences · Observational Study
ClinicalTrials.gov · November 6, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07921888). This is a study registration, not published results. Lead sponsor: Eun Hye Lee. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 40 participants (ESTIMATED). Conditions: Non-Small Cell Lung Cancer, Minimal Residual Disease. Interventions: DIAGNOSTIC_TEST: Patient-specific tumor-informed MRD assay (plasma and bronchial washing ctDNA); PROCEDURE: Bronchoscopy with bronchial washing for reserach. Primary outcome measures: Recurrence-free survival (RFS) according to MRD status in plasma and/or BWF ctDNA , Up to 24 months after surgery. Brief summary: This is a multicenter, prospective, observational pilot cohort study in patients with surgically resected non-small cell lung cancer (NSCLC, pathologic stage IA3-IIIA). Whole exome sequencing (WES) of each patient's resected tumor tissue and matched normal blood (buffy coat) is used to build a patient-specific (tumor-informed) minimal residual disease (MRD) panel, after excluding germline and clonal hematopoiesis variants. MRD is then assessed in paired plasma circulating tumor DNA (ctDNA) and bronchial washing fluid (BWF) ctDNA collected at 6, 12, 18 and 24 months after surgery. The study evaluates whether MRD positivity in plasma and/or BWF is associated with subsequent clinical or radiologic recurrence, compares MRD detection rates and quantitative values between plasma and BWF, and explores the lead time of MRD detection relative to standard surveillance with chest CT and serum CEA. MRD results are not used to confirm recurrence or to change treatment; all clinical decisions follow standard of care. Forty participants will be enrolled at three Severance hospitals in Korea.