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Investigators established the efficacy evaluation criteria for tumor markers (RecistTM) in the preliminary research. Among patients with advanced non-small cell lung cancer, patients with positive driving genes are more likely to exhibit abnormalities in tumor markers, which suggests that this criteria may be more suitable for evaluating the efficacy of targeted therapy in driving gene positive patients. Moreover, The judgment rules of the prelimary criteria still need further improvement. Therefore, in order to broaden the application scope of the RecistTM criteria, further improve the evaluation rules of RecistTM criteria, and multi-dimensionally confirm the reliability of RecistTM criteria on efficacy evaluation, investigators plan to conduct research on the application of RecistTM criteria in evaluating the efficacy of targeted therapy for advanced non-small cell lung cancer with positive driving genes.
Investigators established the efficacy evaluation criteria for tumor markers (RecistTM) in the preliminary research. The establishment of this criteria makes the application of tumor markers in clinical efficacy evaluation more objective and solves the problem of consistency in clinical efficacy evaluation. Among patients with advanced non-small cell lung cancer, patients with positive driving genes are more likely to exhibit abnormalities in tumor markers, which suggests that this criteria may be more suitable for evaluating the efficacy of targeted therapy in driving gene positive patients. Moreover, The judgment rules of the preliminary criteria still need further improvement. . Therefore, in order to broaden the application scope of the RecistTM criteria, further improve the evaluation rules of RecistTM criteria, and multi-dimensionally confirm the reliability of RecistTM criteria on efficacy evaluation, investigators plan to conduct research on the application of RecistTM criteria in evaluating the efficacy of targeted therapy for advanced non-small cell lung cancer with positive driving genes. Investigators used statistical analysis to assess the consistency of efficacy evaluation between the RecistTM criteria and the RECIST criteria, the correlation between different efficacy and progression free survival (PFS) under the RecistTM, and the correlation between the efficacy of RecistTM criteria and ctDNA level.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RecistTM criteria | Diagnostic Test | RecistTM criteria and RECIST criteria were used to evaluate the efficacy of targeted therapy for NSCLC with positive driving gene. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation consistency | The ratio of the number of patients with the same efficacy evaluated both by RecistTM and Recist criteria to the total number of the patients. | efficacy evaluation at the 1st, 3rd, 6th month after treatment, and every 3 months thereafter up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival (PFS) | The correlation between the efficacy evaluation results of the RecistTM criteria and the RECIST criteria and PFS | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| The correlation between the efficacy evaluation results of the RecistTM criteria and the results of ctDNA testing | The correlation between the efficacy evaluated by the RecistTM criteria and the ctDNA amounts detected by NGS | At the 1st, 3rd, 6th month after treatment, and at the time of disease progression, up to 2 years |
Inclusion Criteria:
Exclusion Criteria:
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NSCLC patients with stage IIIB-IV,Driver gene positive, and any one of the tumor markers is more than three times higher than the normal level,
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xueqin Yang, PhD | Contact | 15923366936 | yangxueqin@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Center, Dapping Hospital, Army Medical Center of PLA | Recruiting | Chongqing | Chongqing Municipality | 400042 | China |
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| ID | Term |
|---|---|
| D066066 | Response Evaluation Criteria in Solid Tumors |
| ID | Term |
|---|---|
| D016896 | Treatment Outcome |
| D011379 | Prognosis |
| D003933 | Diagnosis |
| D017063 | Outcome Assessment, Health Care |
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Patient ctDNA samples are used for NGS detections, with each patient planning to take blood 3-4 times。
| D010043 |
| Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017531 | Health Care Evaluation Mechanisms |
| D017530 | Health Care Quality, Access, and Evaluation |