An observational study in Non-Small Cell Lung Cancer and Minimal Residual Disease, sponsored by Eun Hye Lee. Recruiting at 3 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Eun Hye Lee · Observational
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.
Background. Postoperative recurrence is frequent in resected early-stage and locally advanced NSCLC (stage I-IIIA), most often within 2-3 years after surgery. Standard surveillance relies on chest CT and serum tumor markers such as CEA, which cannot detect molecular recurrence at the MRD stage before it appears on imaging. ctDNA-based MRD assessment is being actively investigated in several solid tumors. In early-stage lung cancer, however, plasma ctDNA levels after surgery are very low, which may limit detection sensitivity. Bronchial washing fluid reflects the local tumor environment of the lung, and prior studies suggest it may detect tumor-derived mutations with higher sensitivity than plasma. This study builds a patient-specific, tumor-informed MRD panel for each participant, instead of relying on a fixed generic gene panel, and evaluates plasma and BWF MRD in parallel.
Hypotheses. (1) A patient-specific MRD panel built from resected tumor tissue and normal control specimens can detect postoperative recurrence earlier than conventional imaging-based diagnosis. (2) BWF ctDNA, which reflects the local tumor environment, may show higher MRD detection sensitivity than plasma ctDNA.
Objectives. The primary objective is to evaluate whether MRD positivity in plasma and BWF is associated with subsequent clinical or radiologic recurrence in resected NSCLC. The secondary objectives are (a) to compare MRD detection rates and quantitative values between plasma and BWF and determine which specimen is more sensitive for detecting recurrence, and (b) to explore the lead time of MRD detection relative to recurrence confirmation and compare it with CT and CEA.
Design and procedures. At baseline (first outpatient visit within 1 month after surgery), unstained (10) and stained (1) slides of the surgical pathology specimen are obtained, together with blood for normal control and cfDNA. WES is performed on tumor tissue and buffy coat, and a patient-specific mutation panel is designed. At 6, 12, 18 and 24 months after surgery, 20 mL of blood and 20 mL of BWF (collected by bronchoscopy from the lobe or segment of the original lesion, using saline) are obtained for MRD analysis. Additional blood/BWF MRD assessments may be performed at unscheduled visits when recurrence is clinically suspected. MRD follow-up ends at 24 months, recurrence or death. After 24 months, participants are followed under standard practice (CT and CEA every 3 months) without additional MRD testing. All specimens are shipped under anonymized serial codes to an external laboratory (IMBDx) for analysis and are handled according to the participant's consent regarding retention and secondary use.
Statistical analysis. The main analysis set includes enrolled participants whose patient-specific panel was successfully built and who have at least one evaluable postoperative MRD result. Recurrence-free survival (RFS) of MRD-positive and MRD-negative groups is estimated by the Kaplan-Meier method and compared with the log-rank test. Hazard ratios with 95% confidence intervals are estimated by Cox regression as exploratory analyses. Paired plasma-BWF detection rates are compared with McNemar's test, and paired quantitative values (variant allele frequency) with the paired t-test or Wilcoxon signed-rank test. Sensitivity, specificity, PPV, NPV, ROC curve and AUC are computed exploratorily. Lead time is summarized descriptively. Missing data are not imputed. Because this is a pilot study of 40 participants, results are interpreted by effect sizes and confidence intervals rather than formal significance testing.
Safety and monitoring. MRD results are not used alone to confirm recurrence or change adjuvant therapy. Adverse events related to blood sampling and bronchoscopy are recorded. An independent safety monitor, who is not a member of the study team, will perform two monitoring visits. Serious adverse events are reported according to each institution's IRB requirements. Data from all sites are de-identified, coded, and managed centrally.
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's planned enrollment of 40 is below the median of 160 across 1,148 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →This is the only study on the registry with Eun Hye Lee as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Adult patients (aged 19 years or older) who underwent curative-intent (R0) surgical resection for pathologically confirmed non-small cell lung cancer (NSCLC) with a final pathologic stage of IA3 to IIIA, and who are followed at three tertiary referral hospitals in Korea (Severance Hospital, Gangnam Severance Hospital, and Yongin Severance Hospital). Eligible patients are identified through outpatient and inpatient medical record review and enrolled within 1 month after surgery. A total of 40 participants will be enrolled competitively across the three sites over 2 years.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults who underwent curative-intent (R0) resection for pathologic stage IA3-IIIA NSCLC. Participants undergo patient-specific MRD panel construction and serial plasma and BWF MRD testing at 6, 12, 18 and 24 months after surgery.
Diagnostic Test: Patient-specific tumor-informed MRD assay (plasma and bronchial washing ctDNA) · Procedure: Bronchoscopy with bronchial washing for reserach
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 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.
Recurrence-free survival (RFS) according to MRD status in plasma and/or BWF ctDNA
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.
Time frame: Up to 24 months after surgery
MRD detection rate in plasma ctDNA versus BWF ctDNA
Proportion of MRD-positive results in paired plasma and BWF samples collected at the same time point, compared with McNemar's test.
Time frame: 6, 12, 18 and 24 months after surgery
Quantitative MRD value (variant allele frequency) in plasma versus BWF
ariant allele frequency of patient-specific variants in paired plasma and BWF samples, compared with the paired t-test or Wilcoxon signed-rank test.
Time frame: 6, 12, 18 and 24 months after surgery
Diagnostic performance of MRD for recurrence
Sensitivity, specificity, positive predictive value, negative predictive value, and area under the ROC curve (AUC) of plasma and BWF MRD for detecting recurrence, evaluated exploratorily and compared descriptively with CT and CEA.
Time frame: Up to 24 months after surgery
Lead time of MRD positivity before recurrence confirmation
Interval (months) from first MRD positivity to recurrence confirmed by CT or clinical diagnosis, summarized as mean ± SD or median (IQR), range, and 95% confidence interval, and compared with CT and CEA.
Time frame: Up to 24 months after surgery
Plan to share: No — Data will be de-identified and managed centrally; individual participant data are not planned to be shared at this time.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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