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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorShanghai Chest Hospital

About this trial

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

Qualifiers

Provision of informed consent prior to study initiation.

Age between 18 and 75 years.

Preoperative clinical evaluation indicating non-small cell lung cancer (NSCLC) stage I-IIIB (without initial treatment sought).

Newly treated patients who have consented to undergo surgery.

Disqualifiers

Non-small cell lung cancer (NSCLC) histopathologically determined to be other than stage I-IIIB following surgical evaluation.

Presence of other active malignant tumor diseases.

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.

History of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid therapy, or any indication of clinically active ILD.

Trial design

Treatments tested in this trial

  • Blood ctDNA + methylation + PET-CT and Postoperative pathology
  • MRD+ methylation (or combined with PET-CT) and Invasive mediastinoscopy /EBUS-TBNA
  • Intraoperative lymph node dissection

Treatment groups

200 Participants
are divided into 3 treatment groups

Sponsors and collaborators