MRD Monitoring in Lung Cancer After Resection

Study Overview
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Brief Summary
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The conception of molecular residual disease (MRD) extending from hematologic tumor to solid tumors. Evidences supporting MRD evaluation for lung cancer by liquid biopsy has gradually accumulated, especially circulating tumor DNA (ctDNA). In this observational study, the investigators prospectively enroll stage I-IIIA non-small cell lung cancer (NSCLC) patients who underwent complete resection. Preoperative blood sample, tumor tissue and dynamic postoperative blood samples are collected continuously for MRD detection. This study aim to explore the prognostic value of MRD for stage I-IIIA NSCLC patients after complete resection.

Detailed Description
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There will be a rapid surge in research about molecular residual disease (MRD) for solid cancer in the near future. However, MRD differed significantly between tumor types and between contexts; there continues to be a considerable lack of awareness and knowledge about using MRD in lung cancer. Hence, this study aims to investigate the value of MRD in NSCLC patients who underwent complete resection. Preoperative blood sample (20ml), tumor tissue and dynamic postoperative blood samples (20ml) are collected continuously for MRD detection. The follow-up was performed once every 3 to 6 months. The primary objective of this study is to assess the prognostic value of MRD for stage I-IIIA NSCLC patients after complete resection.

Official Title
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Dynamic Molecular Residual Disease Detection in Stage I-IIIA Non-Small Cell Lung Cancer After Radical Resection

Conditions
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Lung Cancer

Intervention / Treatment
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* Diagnostic Test: MRD detection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of histologically confirmed NSCLC (WHO 2015 classification) with resectable (stage I-IIIA) disease. Complete resection Age ≥18 years at the time of screening Capable of giving signed informed consent Exclusion Criteria: Mixed small cell and NSCLC histology Rx, R1 or R2 resection History of other malignant tumors within 5 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stage I-IIIA NSCLC patients after complete resection<br>For stage I-IIIA NSCLC patients who underwent complete resection. | Diagnostic Test: MRD detection<br>* The Geneplus OncoMRD lung assay is used to detect the MRD status.<br>* Other names: Geneplus OncoMRD lung assay;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prognostic value of MRD | The survival difference between MRD positive and MRD negative patients. | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The predictive value of MRD | The separative value adjuvant chemotherapy or target therapy in MRD positive population and MRD negative population. | 5 year | 
| The lead time of MRD | The median lead time of detectable MRD before regular imaging finding. | 5 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Molecular residual disease, Circulating tumor DNA, Disease relapse, Predictive value