Predicting lymph node metastasis in non-small cell lung cancer using blood tests and imaging
Predicting NSCLC Lymph Node Metastasis: Integrating ctDNA Mutation/ Methylation Profiling With PET-CT Scan: The LUNon-invasive Study
This study is testing if blood tests and imaging can help predict if non-small cell lung cancer has spread to lymph nodes in patients before surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Chest Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06358222 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with newly diagnosed stage I-IIIB NSCLC who are scheduled for surgery.
Not a fit: Patients with other active malignancies or those with serious uncontrolled systemic illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate predictions of lymph node metastasis, potentially improving surgical outcomes for NSCLC patients.
How similar studies have performed: While similar approaches using ctDNA and imaging have shown promise, this specific integration of methodologies is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai
- Shanghai Chest Hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Feng Yao, PhD
- Email: yaofeng@shsmu.edu.cn
- Phone: 021-2220000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.