Monitoring molecular residual disease in lung cancer after surgery
Dynamic Molecular Residual Disease Detection in Stage I-IIIA Non-Small Cell Lung Cancer After Radical Resection
This study looks at patients with early-stage lung cancer who have had surgery to see if testing their blood for leftover cancer DNA can help predict if their cancer will come back.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Guangdong Provincial People's Hospital Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04976296 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with stage I-IIIA non-small cell lung cancer (NSCLC) who have undergone complete surgical resection. It aims to evaluate the prognostic value of molecular residual disease (MRD) by collecting preoperative blood samples, tumor tissue, and dynamic postoperative blood samples for analysis of circulating tumor DNA (ctDNA). Patients will be followed up every 3 to 6 months to assess disease relapse and the predictive value of MRD in this context.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed resectable stage I-IIIA NSCLC who have undergone complete resection.
Not a fit: Patients with mixed small cell and NSCLC histology or those who have had a history of other malignant tumors within the last 5 years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new method for early detection of disease relapse in lung cancer patients post-surgery.
How similar studies have performed: While there is growing interest in MRD evaluation for solid tumors, this specific approach in lung cancer is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of histologically confirmed NSCLC (WHO 2015 classification) with resectable (stage I-IIIA) disease. * Complete resection * Age ≥18 years at the time of screening * Capable of giving signed informed consent Exclusion Criteria: * Mixed small cell and NSCLC histology * Rx, R1 or R2 resection * History of other malignant tumors within 5 years
Where this trial is running
Guangzhou, Guangdong
- Guangdong Lung Cancer Institute & Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Xue-Ning Yang, Ph.D
- Email: yangxuening@gdph.org.cn
- Phone: 020-83827812-51311
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.