Liquid Biopsy-Based Novel Modality for Postoperative Management of Lung Cancer

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?

Conditions

• Non-small Cell Lung Cancer
• Minimal Residual Disease
• Adaptive Treatment

Interventions

OTHER

Adaptive postoperative management based on minimal residual disease

participants will not receive postoperative treatment if (neoadjuvant therapy efficacy reaches pCR and) MRD results keep negative.

Sponsors & Collaborators

• Peking University

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Jiangsu Cancer Institute & Hospital

  collaborator OTHER

• Shanghai Chest Hospital

  collaborator OTHER

• Shandong Cancer Hospital and Institute

  collaborator OTHER

• Shenzhen Third People's Hospital

  collaborator OTHER

• Second Xiangya Hospital of Central South University

  collaborator OTHER

• Shanghai Zhongshan Hospital

  collaborator OTHER

• Peking University First Hospital

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• National Institute for Occupational Safety and Health (NIOSH/CDC)

  collaborator FED

• Peking University People's Hospital

  lead OTHER

Principal Investigators

• Kezhong Chen, MD · Peking University People's Hospital

• Guangxi Wang, PhD · Peking University

• Jiatao Zhang, MD · Guangdong Provincial People's Hospital

• Rong Yin, MD · Jiangsu Cancer Institute & Hospital

• Ziming Li, MD · Shanghai Chest Hospital

• Yintao Li, MD · Shandong Cancer Hospital and Institute

• Zizi Zhou, MD · Shenzhen Third People's Hospital

• Fang Wu, MD · Second Xiangya Hospital of Central South University

• Jun Yin, MD · Shanghai Zhongshan Hospital

• Yuan Cheng, MD · Peking University First Hospital

• Quanfu Huang, MD · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

• Xiaojun Zhu, PhD · China National Institute for Occupational Safety and Health (NIOSH/CDC)

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-25

Primary Completion

2027-07-31

Completion

2028-07-31

Countries

• China

Study Locations