Patient-specific MRD liquid biopsy for resected NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective observational pilot cohort uses a tumor-informed MRD panel created from each patient’s resected tumor and normal blood. ctDNA is measured in plasma and bronchial washing fluid at 6, 12, 18, and 24 months after surgery to see if MRD positivity associates with later recurrence. The study compares MRD detection rates and quantities between plasma and bronchial washing ctDNA and explores lead time versus standard imaging and serum markers. No MRD results are used to guide treatment decisions; routine clinical management follows standard care. It focuses on early-stage to locally advanced NSCLC (IA3–IIIA) after curative resection.

Why it matters

Who can join: the full rules

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

Where it's running

• Yongin Severance Hospital
  Yongin-si, Gyeonggi-do, South Korea Recruiting
• Severance Hospital
  Seoul, South Korea Not yet recruiting
• Gangnam Severance Hospital
  Seoul, South Korea Not yet recruiting

Study contacts

• Principal investigator: LEE Eunhye, Ph.D.Course of Medical Science — Division of Pulmonology, Allergy and Critical Care Medicine, Department of Internal Medicine, Yongin Severance Hospital, Yonsei University College of Medicine
• Study coordinator: LEE Eunhye, Ph.D.Course of Medical Science
• Email: hieunhye@yuhs.ac
• Phone: +82-10-4099-3780

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.