Patient-Specific MRD Liquid Biopsy in Resected NSCLC: Plasma and Bronchial Washing ctDNA

NCT07921888 · tracked via the Priya Life Science South Korea tracker

Sponsor

Eun Hye Lee

Phase

Observational

Started

2026-09-28

Last updated

2026-11-12

Condition(s) studied

Non-Small Cell Lung CancerMinimal Residual Disease

Investigational drug(s) / intervention(s)

Patient-specific tumor-informed MRD assay (plasma and bronchial washing ctDNA)Bronchoscopy with bronchial washing for reserach

Patient-specific tumor-informed MRD assay (plasma and bronchial washing ctDNA): WES of surgical tumor tissue and matched normal blood to design a patient-specific mutation panel, followed by MRD detection in plasma ctDNA and BWF ctDNA at 6, 12, 18 and 24 months after surgery and at unscheduled visits if recurrence is suspected. Results are not used for treatment decisions.

Bronchoscopy with bronchial washing for reserach: Bronchoscopy performed by the treating pulmonologist, with 20 mL saline bronchial washing from the lobe or segment of the original tumor, at 6, 12, 18 and 24 months after surgery.

Study 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 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.

Eligibility

Sex

ALL

Min age

19 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Adults aged 19 years or older * Pathologically confirmed non-small cell lung cancer who underwent curative-intent complete (R0) surgical resection * Final pathologic stage IA3 (tumor size \>2 cm) to IIIA after surgery * Able to attend the first outpatient visit within 1 month after surgery, and agrees to research blood sampling, provision of surgical tissue slides, and long-term follow-up * Provided voluntary written informed consent after adequate explanation of the study purpose and methods Exclusion Criteria: * Pathologic stage IA1 or IA2 (tumor size ≤2 cm), stage IV, or confirmed distant metastasis * Incomplete resection (non-R0) or clear residual tumor after surgery * History of other malignancy, including synchronous malignancy in another organ, that may confound interpretation of MRD results (cancers judged cured for more than 5 years may be included) * Poor performance status or other conditions making repeated blood sampling or bronchoscopy difficult * Unstable cardiopulmonary function, or high risk with sedation or additional procedures, in the judgment of the treating physician * Unable to provide informed consent, or judged unable to comply with regular follow-up during the study period

Primary outcome measure(s)

Recurrence-free survival (RFS) according to MRD status in plasma and/or BWF ctDNA — Up to 24 months after surgery
RFS of MRD-positive versus MRD-negative participants, defined as the time from surgery to first clinical or radiologic recurrence (or death, if applicable). Estimated by the Kaplan-Meier method and compared with the log-rank test. Hazard ratio with 95% confidence interval estimated exploratorily by Cox regression.

Trial sites (3)

Facility	City	Region	Status
Yongin Severance Hospital	Yongin-si	Gyeonggi-do	Recruiting
Severance Hospital	Seoul	South Korea	Not Yet Recruiting
Gangnam Severance Hospital	Seoul	South Korea	Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07921888 on ClinicalTrials.gov ↗ ← All trials in South Korea