Development and Validation of Non-Invasive Monitoring Techniques for Postoperative Recurrence and Novel Adjuvant Therapeutic Strategies in Lung Cancer

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this study is to develop new techniques for minimal residual disease(MRD) monitoring and to confirm the efficacy and safety of MRD-guided postoperative management for early stage non-small cell lung cancer. The main questions this study aims to answer are: * How to develop multi-omics-based high-sensitivity detection methods to accurately capture MRD and monitor postoperative recurrence in lung cancer? * Is adaptive treatment guided by ctDNA-MRD for lung cancer patients superior to traditional clinical management and effectively improves survival? * Do heterogeneous patient populations (grouped by stages, histopathological subtypes, driver mutations, and treatment histories) show differences in effects under ctDNA-MRD guided postoperative management strategies?

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Non-small cell lung cancer with stage IA-IIIA (8th edition TNM classification) planning to undergo curative surgery or to undergo neoadjuvant therapy

• Solid nodules \>1 cm or ground-glass nodules \>1.5 cm on imaging

• No history of malignancies other than non-small cell lung cancer in the past 5 years

• Specimens are well preserved and imaging documents are accessible.

Locations
Other Locations
China
Peking University People's Hospital
RECRUITING
Beijing
Contact Information
Primary
Kezhong Chen, MD
mdkzchen@163.com
+86-010-88325983
Backup
Xiaoqiu Yuan
YuanXQ_pkuphxw@foxmail.com
+86-010-88325983
Time Frame
Start Date: 2025-03-25
Estimated Completion Date: 2028-07-31
Participants
Target number of participants: 1000
Treatments
Experimental: adaptive postoperative management group
For those who don't receive neoadjuvant therapy, if the MRD testing results after surgery keep negative, postoperative adjuvant therapy will be waived.~For those who receive neoadjuvant therapy, if the efficacy reaches pathological complete response(pCR) and MRD testing results keep negative, postoperative adjuvant therapy will be waived.~Otherwise, participants will receive a customized treatment plan based on Multi-disciplinary Treatment (MDT).
No_intervention: standard clinical postoperative management group
These participants will receive standard postoperative adjuvant therapy and routine follow-up.
Sponsors
Collaborators: Shanghai Chest Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Shandong Cancer Hospital and Institute, National Institute for Occupational Safety and Health (NIOSH/CDC), Peking University First Hospital, Guangdong Provincial People's Hospital, Jiangsu Cancer Institute & Hospital, Second Xiangya Hospital of Central South University, Shanghai Zhongshan Hospital, Shenzhen Third People's Hospital, Peking University
Leads: Peking University People's Hospital

This content was sourced from clinicaltrials.gov