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
Recruiting · NCT06358222 · Observational (researchers observe without assigning treatment) · Lead sponsor: Shanghai Chest Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Blood ctDNA + methylation + PET-CT and Postoperative pathologyIntraoperative lymph node dissectionMRD+ methylation (or combined with PET-CT) and Invasive mediastinoscopy /EBUS-TBNA
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1.
Exclusion criteria
- 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.
- 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 is running
1 location listed.
- Shanghai Chest Hospital - Shanghai, China