Liquid Biopsy-Based Novel Modality for Postoperative Management of Lung Cancer
NCT ID: NCT06930807
Last Updated: 2025-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1000 participants
INTERVENTIONAL
2025-03-25
2028-07-31
Brief Summary
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* 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?
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Detailed Description
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This study aims to develop a novel multidimensional approach for non-invasive postoperative recurrence monitoring in lung cancer and establish an MRD-guided adjuvant therapy model to optimize precision treatment and MRD-stratified follow-up protocols for lung cancer patients. This study will evaluate the sensitivity and specificity of novel monitoring methods and further compare emerging non-invasive recurrence monitoring approaches with conventional ctDNA-based techniques, driving continuous advancements in lung cancer research.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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).
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.
standard clinical postoperative management group
These participants will receive standard postoperative adjuvant therapy and routine follow-up.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Non-small cell lung cancer with pathologic stage IIIB-IV (8th edition TNM classification)
* Pathology results confirmed not to be non-small cell lung cancer
* History of malignancies other than non-small cell lung cancer in the past 5 years
18 Years
ALL
No
Sponsors
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Peking University
OTHER
Guangdong Provincial People's Hospital
OTHER
Jiangsu Cancer Institute & Hospital
OTHER
Shanghai Chest Hospital
OTHER
Shandong Cancer Hospital and Institute
OTHER
Shenzhen Third People's Hospital
OTHER
Second Xiangya Hospital of Central South University
OTHER
Shanghai Zhongshan Hospital
OTHER
Peking University First Hospital
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
National Institute for Occupational Safety and Health (NIOSH/CDC)
FED
Peking University People's Hospital
OTHER
Responsible Party
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Chen KeZhong
Professor
Principal Investigators
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Kezhong Chen, MD
Role: STUDY_CHAIR
Peking University People's Hospital
Guangxi Wang, PhD
Role: STUDY_DIRECTOR
Peking University
Jiatao Zhang, MD
Role: STUDY_DIRECTOR
Guangdong Provincial People's Hospital
Rong Yin, MD
Role: STUDY_DIRECTOR
Jiangsu Cancer Institute & Hospital
Ziming Li, MD
Role: STUDY_DIRECTOR
Shanghai Chest Hospital
Yintao Li, MD
Role: PRINCIPAL_INVESTIGATOR
Shandong Cancer Hospital and Institute
Zizi Zhou, MD
Role: PRINCIPAL_INVESTIGATOR
Shenzhen Third People's Hospital
Fang Wu, MD
Role: PRINCIPAL_INVESTIGATOR
Second Xiangya Hospital of Central South University
Jun Yin, MD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Zhongshan Hospital
Yuan Cheng, MD
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Quanfu Huang, MD
Role: PRINCIPAL_INVESTIGATOR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Xiaojun Zhu, PhD
Role: PRINCIPAL_INVESTIGATOR
China National Institute for Occupational Safety and Health (NIOSH/CDC)
Locations
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Peking University People's Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023ZD0501900
Identifier Type: -
Identifier Source: org_study_id
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