Monitoring minimal residual disease in stage III lung cancer
Prospective, Observational Study of Molecular Residual, Dynamic Monitoring and Recurrence of Stage III Driver Mutated NSCLC
This study is testing if tracking small amounts of cancer DNA in the blood can help predict if stage III lung cancer will come back and improve treatment for patients with this condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 305 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai Chest Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 11 sites (Xiamen, Fujian and 10 other locations) |
| Trial ID | NCT06443684 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the role of dynamic monitoring of minimal residual disease (MRD) in patients with stage III driver mutated non-small cell lung cancer (NSCLC). It focuses on whether MRD status can predict recurrence events and assess prognosis in these patients. By analyzing peripheral blood samples for driver gene mutations, the study seeks to stratify the risk of recurrence and improve treatment outcomes. The research is particularly relevant given the low survival rates associated with stage III NSCLC.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed stage III non-small cell lung cancer and positive molecular testing for specific driver genes.
Not a fit: Patients with other malignancies within the past five years or those with conditions affecting follow-up may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and treatment strategies for patients with stage III NSCLC, potentially enhancing survival rates.
How similar studies have performed: Previous studies have shown promise in using MRD monitoring for cancer prognosis, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with stage III non-small cell lung cancer were confirmed by imaging and histological biopsy 2. Age≥ 18 3. ECOG PS:0-1 4. Tumor molecular testing by EBUS or biopsy confirmed positive for one or more of the following driver genes:EGFR\\ALK\\ROS1\\RET\\KRAS\\PIK3CA\\BRAF\\HER2\\MET 5. Patients who met and agreed to surgery or radical chemoradiotherapy, and the remaining samples after cutting tissue sections did not affect the possible further clinical treatment of the subject 6. Provide 20 mL peripheral blood samples periodically 7. The subjects volunteered to join the study, and signed the informed consent form, with good compliance, and actively cooperated with the hospital for routine clinical diagnosis and treatment follow-up Exclusion Criteria: 1. Patients with other malignancies within 5 years 2. According to the investigator, the patient also had other diseases that may affect the follow-up and short-term survival 3. The subject had other factors that may lead to the termination of the study, such as other serious diseases (including mental illness), serious laboratory abnormalities, and family or social factors that affected the safety of the subject, or the collection of data and samples
Where this trial is running
Xiamen, Fujian and 10 other locations
- First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (Recruiting)
- The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
- Affiliated Cancer Hospital of Harbin Medical University — Harbin, Heilongjiang, China (Recruiting)
- Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)
- Shandong Provincial Hospital — Jinan, Shandong, China (Recruiting)
- Shanghai Chest hospital — Shanghai, Shanghai Municipality, China (Recruiting)
- Zhongshan Hospital Affiliated to Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
- Shanxi Cancer Hospital — Taiyuan, Shanxi, China (Recruiting)
- The First Affiliated Hospital of Xi 'an Jiaotong University — Xi’an, Shanxi, China (Recruiting)
- The First Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
- Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Shun Lu, M.D. — Shanghai Chest Hospital
- Study coordinator: Ziming Li, M.D.
- Email: liziming1980@hotmail.com
- Phone: 8613764590226
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.