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| Name | Class |
|---|---|
| Peking University People's Hospital | OTHER |
| Tianjin Medical University General Hospital | OTHER |
| Tianjin Medical University Cancer Institute and Hospital | OTHER |
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Conduct a prospective study in multicenter to confirm the value of circulating tumor DNA in longitudinal monitoring of stage III-IV lung cancer patients.
The study consists of two phases, the first stage is the exploratory stage of blood collection point which is the appropriate effective time after chemotherapy, radiotherapy, targeted therapy. The second phase, which is the expansion of the first phase, is to determine the precise leading time of ctDNA relative to tumor biomarkers or image evaluation in determining the efficacy of advanced NSCLC cancer therapy. Both stages were divided into three subgroups: the chemotherapy group, the radiotherapy group, and the targeted therapy group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The chemotherapy cohort | Blood samples for ctDNA and biomarkers analysis are collected at before chemotherapy and at a series of scheduled time-points after chemotherapy , with serial two-weekly blood samples collected from a subset of patients. Meanwhile, imaging technology such as CT scan detection would be performed. | ||
| The radiotherapy cohort | Blood samples for ctDNA and biomarkers analysis are collected at before radiotherapy and at a series of scheduled time-points after radiotherapy, with serial two-weekly blood samples collected from a subset of patients. Meanwhile, imaging technology such as CT scan detection would be performed. | ||
| The targeted therapy cohort | Blood samples for ctDNA and biomarkers analysis are collected at before targeted therapy and at a series of scheduled time-points after targeted therapy, with serial two-weekly blood samples collected from a subset of patients. Meanwhile, imaging technology such as CT scan detection would be performed. |
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| Measure | Description | Time Frame |
|---|---|---|
| ctDNA effective time | To explore the appropriate chemo/ radio/ target effective time (CET/RET/TET) through measurement and monitoring of ctDNA after anti-cancer therapies in advanced NSCLC. | 6 months |
| ctDNA leading time | To investigate the precise leading time for ctDNA compared to conventional biomarker or image evaluation in detecting disease recurrence after radiotherapy, chemotherapy, or targeted therapy respectively. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the accuracy of ctDNA | To assess the accuracy of ctDNA when imaging undetectable or difficult to assess | 1 year |
| Compared to conventional image | Compared to conventional image evaluation, to determine the consistency of ctDNA in treatment response of measurable lesion after radiotherapy, chemotherapy, or targeted therapy respectively |
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Inclusion Criteria:
Exclusion Criteria:
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The population will be drawn from Oncology Department of multicenters. The enrolled patients must be patients with stage III-IV NSCLC according to the 8th edition of the TNM Classification of the International Association for the Study of Lung Cancer (IASLC), must be greater than 18 years old and must have the tissue specimens (fresh or wax blocks) before this treatment. The exclusion criteria are as followed: (1) Multiple primary lung cancer;(2) Incorporating any unstable systemic disease; (3) Histology is not NSCLC; (4)Unqualified blood samples; (5) Patients lacking any one of the detection points. All of the patients signing informed consent were not involved in the recruitment and conduct of the study
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Zhang, M.D. | Contact | 17603119607 | +86 | 13315978836@163.com |
| Kezhong Chen, M.D. | Contact | 13488752289 | +86 | mdkzchen@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yan Zhang, M.D. | The First Hospital of Shijiazhuang | Principal Investigator |
| Jun Wang, M.D. | Peking University People's Hospital | Study Chair |
| Kezhong Chen, M.D. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D002283 | Carcinoma, Bronchogenic |
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| Affiliated Hospital of Hebei University |
| OTHER |
| Hebei Medical University Fourth Hospital | OTHER |
| Xingtai People's Hospital | OTHER |
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Fresh tumor tissue and blood samples were collected from each patient. Histological specimens (fresh or paraffin blocks) of all enrolled patients before treatment need to be obtained, and according to different adjuvant therapy, blood samples were collected at a series of specific scheduled time-points
| 1 year |
| Compared to traditional tumor markers | To explore the consistency for ctDNA in determining the efficacy of advanced NSCLC compared to tumor markers after radiotherapy, chemotherapy, or targeted therapy respectively | 6 months |
| Peking University People's Hospital |
| Study Director |
| Affiliated Hospital of Hebei University | Recruiting | Baoding | Hebei | 071000 | China |
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| Hebei Medical University Fourth Hospital | Recruiting | Shijiazhuang | Hebei | 050011 | China |
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| The First Hospital of Shijiazhuang | Recruiting | Shijiazhuang | Hebei | 050011 | China |
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| Xingtai People's Hospital | Recruiting | Xingtai | Hebei | 054031 | China |
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| Handan Downtown Hospital | Recruiting | Handan | Heibe | 056001 | China |
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| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | Tianjin Municipality | 300000 | China |
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| Tianjin Medical University General Hospital | Recruiting | Tianjin | Tianjin Municipality | 300052 | China |
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| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |