Predicting lymph node metastasis in non-small cell lung cancer using blood tests and imaging

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 observational study aims to predict lymph node metastasis in patients with non-small cell lung cancer (NSCLC) by integrating circulating tumor DNA (ctDNA) mutation and methylation profiling with PET-CT imaging. It consists of three stages: the first involves enrolling patients scheduled for lobectomy to establish ctDNA methylation signatures associated with lymph node metastasis. The second stage assesses the detection rate of lymph node metastasis in patients requiring further invasive procedures based on their ctDNA profiles and imaging results. The final stage compares outcomes of patients with negative preoperative testing to evaluate the effectiveness of lymph node dissection.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai Chest Hospital
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Feng Yao, PhD
• Email: yaofeng@shsmu.edu.cn
• Phone: 021-2220000

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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.