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In the past few years, circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), microRNAs, autoantibodies, and T-cell receptor repertoire are new biomarkers of liquid biopsy in cancer, which has been demonstrated to have a great value in diagnostics, treatment evaluation, and prognosis prediction. However, most of previous data were based on late stage tumor patients. This study plans to utilize the minimally invasive method to detect the changes of numbers of CTCs, ctDNA hot spot mutations and methylation signals, microRNAs, autoantibodies, and T-cell receptor repertoire in early stage lung cancer patients before and after pulmonary nodule biopsy, during therapeutic and follow-up periods, in order to evaluate the clinical values of above tumor-related biomarkers.
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| Measure | Description | Time Frame |
|---|---|---|
| Death or survival | Death or survival | Baseline and every three- or six-month follow-up within two years for each patient. |
| Disease progress | Complete Response(CR), Partial Response(PR), Stable Disease(SD), Progressive Disease(PD) | Baseline and every three- or six-month follow-up within two years for each patient. |
| Reasons of study termination | Complete the study, Lost to follow-up, Withdrawal of informed consent, Terminated by the investigator, Severe adverse event(SAE). | Baseline and every three- or six-month follow-up within two years for each patient. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with pulmonary nodules (single or multiple) by CT scans.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jieping LEI, Ph.D. | Contact | 010-84206408 | jiepinglei@126.com | |
| Sinan WU, M.D. | Contact | 010-84206408 | tks0423@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Chen WANG, Ph.D. | China-Japan Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Recruiting | Beijing | Beijing Municipality | 100029 | China |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Blood and tissue
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |