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| Name | Class |
|---|---|
| Peking University | OTHER |
| Guangdong Provincial People's Hospital | OTHER |
| Jiangsu Cancer Institute & Hospital | OTHER |
| Shanghai Chest Hospital |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adaptive postoperative management group | Experimental | 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). |
|
| standard clinical postoperative management group | No Intervention | These participants will receive standard postoperative adjuvant therapy and routine follow-up. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adaptive postoperative management based on minimal residual disease | Other | participants will not receive postoperative treatment if (neoadjuvant therapy efficacy reaches pCR and) MRD results keep negative. |
| Measure | Description | Time Frame |
|---|---|---|
| Two-year recurrence-free survival rate | The difference in the proportion of patients with (suspected) relapse or metastasis between the intervention group and the control group within two years. | Time from curative surgery to confirmation of clinical progression (recurrence or metastasis) within two years. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The difference in overall survival between the intervention group and the control group. | Time from curative surgery to confirmation of death (any cause)，assessed up to 60 months. |
| Incremental cost effectiveness ratio |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kezhong Chen, MD | Contact | +86-010-88325983 | mdkzchen@163.com | |
| Xiaoqiu Yuan | Contact | +86-010-88325983 | YuanXQ_pkuphxw@foxmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Kezhong Chen, MD | Peking University People's Hospital | Study Chair |
| Guangxi Wang, PhD | Peking University | Study Director |
| Jiatao Zhang, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D018365 | Neoplasm, Residual |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| 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 |
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The cost of lung cancer-related treatment, including the cost of drugs, follow-up treatment, drug management costs (consultation fees, anti-tumor drug allocation fees, intravenous infusion fees, nursing fees, etc.), follow-up costs, laboratory tests and imaging examination costs, and the management costs of adverse reactions (1 cycle is counted as 1 time), and the per capita standard expenses calculated according to the Checkmate816 study protocol and China's expenses were used to calculate ICER.
| 24 months after surgery |
| Timely diagnosis rate by the novel MRD monitoring technique | The proportion of patients with recurrence signals detected by non-invasive methods prior to clinical confirmation of recurrence/metastasis, and quantify the mean lead time. | two years |
| Sensitivity of the novel MRD monitoring approach | Evaluate the sensitivity of the novel MRD-based assay against previous ctDNA-MRD-only approaches. Use receiver operating characteristic (ROC) curves and limit of detection (LoD) analyses for cross-platform comparison. | two years |
| Guangdong Provincial People's Hospital |
| Study Director |
| Rong Yin, MD | Jiangsu Cancer Institute & Hospital | Study Director |
| Ziming Li, MD | Shanghai Chest Hospital | Study Director |
| Yintao Li, MD | Shandong Cancer Hospital and Institute | Principal Investigator |
| Zizi Zhou, MD | Shenzhen Third People's Hospital | Principal Investigator |
| Fang Wu, MD | Second Xiangya Hospital of Central South University | Principal Investigator |
| Jun Yin, MD | Shanghai Zhongshan Hospital | Principal Investigator |
| Yuan Cheng, MD | Peking University First Hospital | Principal Investigator |
| Quanfu Huang, MD | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Principal Investigator |
| Xiaojun Zhu, PhD | China National Institute for Occupational Safety and Health (NIOSH/CDC) | Principal Investigator |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |