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

Launched by SHANGHAI CHEST HOSPITAL · Apr 6, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how to better predict whether non-small cell lung cancer (NSCLC) has spread to the lymph nodes. Researchers are combining information from a special blood test that checks for cancer DNA (called ctDNA) with imaging scans (PET-CT) to see if they can get a clearer picture of the cancer's status before surgery. The goal is to improve how doctors assess the disease and tailor treatment options for patients.

To be eligible for this trial, participants should be between 18 and 75 years old, have not yet received treatment for their NSCLC, and be planning to have surgery. They will need to provide consent to take part and be in good health overall. If you join the study, you can expect to undergo some tests and imaging to help determine the best approach for your treatment. It's important to note that individuals with certain health issues or other active cancers will not be able to participate in this trial.

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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 exclusion.
• • 4. History of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid therapy, or any indication of clinically active ILD.
• • 5. Patients considered by the investigator to be unable to comply with the study protocol, restrictions, and requirements, or those facing circumstances at the investigator's discretion that would impede their participation in the study.