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

NCT ID: NCT06930807

Last Updated: 2025-04-16

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-25

Study Completion Date

2028-07-31

Brief Summary

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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?

Detailed Description

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Approximately 30% of early-stage lung cancer patients experience recurrence after curative surgery. However, the clinical utility of routine chest CT surveillance remains limited. Emerging evidence has demonstrated that liquid biopsy-based minimal residual disease (MRD) detection may serve as a more sensitive monitoring strategy. Longitudinal ctDNA dynamics analysis further enables real-time assessment of tumor progression and early detection of molecular relapse.

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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Non-small Cell Lung Cancer Minimal Residual Disease Adaptive Treatment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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).

Group Type EXPERIMENTAL

Adaptive postoperative management based on minimal residual disease

Intervention Type OTHER

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.

Group Type NO_INTERVENTION

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Age\<18 years old
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University

OTHER

Sponsor Role collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role collaborator

Jiangsu Cancer Institute & Hospital

OTHER

Sponsor Role collaborator

Shanghai Chest Hospital

OTHER

Sponsor Role collaborator

Shandong Cancer Hospital and Institute

OTHER

Sponsor Role collaborator

Shenzhen Third People's Hospital

OTHER

Sponsor Role collaborator

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role collaborator

Peking University First Hospital

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role collaborator

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

FED

Sponsor Role collaborator

Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chen KeZhong

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Kezhong Chen, MD

Role: CONTACT

+86-010-88325983

Xiaoqiu Yuan

Role: CONTACT

+86-010-88325983

Facility Contacts

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Kezhong Chen, MD

Role: primary

+86-010-88325983

Other Identifiers

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2023ZD0501900

Identifier Type: -

Identifier Source: org_study_id

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