NCT06358222 Predicting Non-small Cell Lung Cancer (NSCLC) Lymph Node Metastasis: Integrating Circulating Tumor DNA (ctDNA) Mutation/ Methylation Profiling With Positron Emission Tomography-computed Tomography (PET-CT) Scan
| NCT ID | NCT06358222 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Chest Hospital |
| Condition | Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-12-15 |
| Primary Completion | 2027-12-31 |
Trial Parameters
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Brief Summary
This is a single center, prospective and observational study conducted in three stages to predict the NSCLC lymph node metastasis based on ctDNA/specific methylation molecular features combined with PET-CT imaging features and intervention study.
Eligibility Criteria
Inclusion Criteria: 1. Provision of informed consent prior to study initiation. 2. Age between 18 and 75 years. 3. Preoperative clinical evaluation indicating non-small cell lung cancer (NSCLC) stage I-IIIB (without initial treatment sought). 4. Newly treated patients who have consented to undergo surgery. 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1. Exclusion Criteria: 1. Non-small cell lung cancer (NSCLC) histopathologically determined to be other than stage I-IIIB following surgical evaluation. 2. Presence of other active malignant tumor diseases. 3. Evidence of any serious or uncontrolled systemic illness, including uncontrolled hypertension and active bleeding, as assessed by the investigator, which may contribute to reluctance to participate in the trial or decrease adherence to the study regimen. Additionally, active infectious diseases such as hepatitis B, hepatitis C, and human immunodeficiency virus (HIV) infection are grounds for exclusi