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| Name | Class |
|---|---|
| Geneplus-Beijing Co. Ltd. | INDUSTRY |
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Stratification of postoperative ctDNA status can effectively assess the risk of recurrence in patients. In addition, the multi-node dynamic monitoring of ctDNA is more effective in predicting the recurrence risk of patients. In this study, EGFR/ALK negative potentially resectable Stage III non-small cell lung cancer were enrolled. Baseline tissues, Peripheral blood samples of patients at baseline puncture tissue, after neoadjuvant therapy, after surgery (if any), after adjuvant therapy, and at multiple nodes during follow-up were collected for 1021-MRD analysis through tumor-informed personalized monitoring MRD test kit. This study aim to explore MRD biomarker in patients with potentially resectable stage III non-small cell lung cancer.
In this prospective study, 65 patients with potentially operable non-small cell lung cancer without driving gene EGFR/ALK mutation in stage III were enrolled in this prospective study. peripheral blood samples from multiple nodes after neoadjuvant therapy, postoperative (if any), adjuvant therapy and follow-up were collected and analyzed by high-throughput sequencing in the target region. Patients were enrolled in the study for 1 year, followed up for 2 years, and the study lasted for 3 years. The patients were followed up for 2 years according to the standard diagnosis and treatment path, with a total of 9 times of follow-up, all of which were 3-month follow-up plan of the standard diagnosis and treatment path, and the follow-up examination was conducted in accordance with clinical standards.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arms1:For stage III NSCLC patients who underwent complete resection. | Immunotherapy alone or chemotherapy combined with immunotherapy. Collect patients' baseline puncture tissues, peripheral blood samples from multiple nodes after new adjuvant treatment, surgery (if any), adjuvant treatment, and follow-up, and carry out for 1021-MRD analysis through tumor-informed personalized monitoring MRD test kit. Assigned Interventions:1021-MRD analysis | ||
| Arms 2:For stage III NSCLC patients who underwent concurrent radio-chemotherapy. | Immunotherapy alone or chemotherapy combined with immunotherapy. Collect patients' baseline puncture tissues, peripheral blood samples from multiple nodes after new adjuvant treatment, surgery, adjuvant treatment, and follow-up, and carry out for 1021-MRD analysis through tumor-informed personalized monitoring MRD test kit. Assigned Interventions:1021-MRD analysis |
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| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival (RECIST) | Disease-free survival (RECIST): the survival time from operation or radiation to recurrence | follow-up time: 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| OS | overall survival from the enrollment to death | follow-up for 2 years |
| The prediction of recurrence by positive MRD | Whether the prediction of recurrence by positive MRD is earlier than that confirmed by clinical diagnosis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuyan Wang | Contact | 010-88196497 | wangyuyan1219@aliyun.com | |
| Han Yin | Contact | 01088196084 |
| Name | Affiliation | Role |
|---|---|---|
| Yuyan Wang, doctorate | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yuyan Wang | Recruiting | Beijing | 100142 | China |
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| follow-up for 2 years |
| pCR rate of MRD-negative patient | pCR rate of MRD-negative patient | 2 years |
| Negative MRD rate in pCR patients | Negative MRD rate in pCR patients | follow-up time: 2 years |
| 2-year DFS of ctDNA-negative patients in operation group / inoperable group | 2-year DFS of ctDNA-negative patients in operation group / inoperable group | follow-up time: 2 years |