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A prospective, observational study that assesses the clinical feasibility of ctDNA-based liquid biopsy in patients with oligometastatic NSCLC receiving surgery.
60 eligible patients will be enrolled. Dynamic blood samples before and after surgery and tissue samples will be obtained for exploratory analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oligometastatic disease | Dynamic blood samples before and after surgery and tissue samples from oligometastatic NSCLC undergone surgery will be obtained for exploratory analysis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ctDNA testing and whole exome sequencing | Genetic | Blood samples will be obtained for ctDNA testing and tumor tissue for whole exome sequencing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Association between perioperative ctDNA-MRD characteristics and rogression-free survival | To explore the potential association among perioperative ctDNA-MRD characteristics and rogression-free survival within 2 years. | 2-year PFS |
| Construction of a survival-prediction model | The survival-prediction model based on clinicopathological and genomic characteristics. | Through study completion, up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Association among ctDNA status before surgery, systemic treatment times, and survival | To explore the potential association among plasma ctDNA status surgery, systemic treatment time duration, PFS and OS. | Through study completion, up to 5 years |
| Genomic characteristics and clonal evolution after systemic treatment |
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Inclusion Criteria:
Oligoresidual after induction therapy: after systemic therapy, distant metastases were stable or reduced, primary lesions were stable or reduced, PET/CT metabolism was reduced, and no more than 5 residual lesions and no more than 3 organs were involved.
Oligoprogression after induction therapy: After systemic therapy, some lesions were stable or reduced, while some original lesions were larger than before.
Oligorelapses after induction therapy: after systemic therapy, systemic lesions were stable or reduced, and new local lesions appeared.]
Exclusion Criteria:
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Stage IV NSCLC patients with oligometastases at initial diagnosis or oligoresidual or oligoprogression or oligorelapses after systemic therapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wen-Zhao Zhong, Ph.D | Contact | +86 02083827812 | syzhongwenzhao@scut.edu.cn | |
| Rui Fu, M.D. | Contact | +86 02083827812 | ruifu66@foxmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Wen-Zhao Zhong, Ph.D | Guangdong Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences | Recruiting | Guangzhou | Guangdong | 510080 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000073359 | Exome Sequencing |
| ID | Term |
|---|---|
| D000073336 | Whole Genome Sequencing |
| D017422 | Sequence Analysis, DNA |
| D017421 | Sequence Analysis |
| D005821 | Genetic Techniques |
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Every ctDNA test will take 20ml peripheral blood for DNA extraction.
Using whole-exome sequencing to identify genomic characteristics and clonal evolution after systemic treatment |
| Through study completion, up to 5 years |
| Potential drug-resistance mechanism identified by plasma ctDNA | Using plasma ctDNA-MRD to identify the potential drug-resistance mechanism. | Through study completion, up to 5 years |
| Assess whether ctDNA-MRD is associated with radiological and pathological response after systematic therapy before surgery | Association among perioperative ctDNA-MRD characteristics, imaging response, and pathological response. | 60 patients underwent surgery |
| Heterogeneity in Genomic and transcriptome between primary and metastatic tumors | Using whole-exome sequencing and whole transcriptome sequencing to identify genomic and transcriptome heterogeneity between primary and metastatic tumors. | 60 patients underwent surgery |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008919 |
| Investigative Techniques |