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The purpose of this study is to explore the effect of G-CSF combination with GM-CSF on prevention and treatment of infection in children with malignant tumor.
G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GM-CSF | Experimental | Eligible patients received subcutaneous GM-CSF 5 μg/kg per day when the first time of absolute neutrophil count [ANC] <1.5*10^9/L after chemotherapy. GM-CSF is given daily for at least 5 days and continued until the ANC reached 1.5*10^9/L for two consecutive days. |
|
| G-CSF | Experimental | Eligible patients received subcutaneous G-CSF 5 μg/kg per day when the first time of absolute neutrophil count [ANC] <1.5*10^9/L after chemotherapy. G-CSF is given daily for at least 5 days and continued until the ANC reached 1.5*10^9/L for two consecutive days. |
|
| G-CSF + GM-CSF | Experimental | Eligible patients received subcutaneous a combination of GM-CSF 5 μg/kg per day and G-CSF 5 μg/kg per day when the first time of absolute neutrophil count [ANC] <1.5*10^9/L after chemotherapy. GM-CSF and G-CSF are given daily for at least 5 days and continued until the ANC reached 1.5*10^9/L for two consecutive days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GM-CSF | Biological | Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a hematopoietic CSFs that decrease the duration and severity of neutropenia for patients receiving chemotherapy. GM-CSF is a stimulator of the growth and differentiation of hematopoietic progenitor cells committed to neutrophils, monocytes or eosinophils. |
| Measure | Description | Time Frame |
|---|---|---|
| assess the incidence of infection in patients after chemotherapy | within 20 days after chemotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuan NO Xiaojun, Ph.D | Contact | +86 13817266192 | xhxjyuan@hotmail.com | |
| Zou NO fenfang, scholar | Contact | +86 18959232025 | zoufenfang@amoytop.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuan Xiaojun, Ph.D | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Study Chair |
| Zhai Xiaowen, Ph.D | Children's Hospital of Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated of Xiamen University | Recruiting | Xiamen | Fujian | 350000 | China |
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|
| G-CSF | Biological | Granulocyte colony-stimulating factor (G-CSF) is a hematopoietic CSFs that decrease the duration and severity of neutropenia for patients receiving chemotherapy. G-CSF is a relatively specific stimulator of the growth and differentiation of hematopoietic progenitor cells committed to the neutrophil lineage. |
|
| GM-CSF and G-CSF | Biological | Granulocyte-macrophage colony-stimulating factor (GM-CSF) and granulocyte colony-stimulating factor (G-CSF) are hematopoietic CSFs that decrease the duration and severity of neutropenia for patients receiving chemotherapy. GM-CSF and G-CSF share a number of biologic activities, GM-CSF seems to be more potent against fungi. |
|
| Hu Shaoyan, Ph.D |
| Children's Hospital of Soochow University |
| Principal Investigator |
| Fang Yongjun, Ph.D | Nanjing Children's Hospital | Principal Investigator |
| Wen Hong, Ph.D | The First Affiliated of Xiamen University | Principal Investigator |
| Wang Hongmei, Ph.D | Qianfoshan Hospital | Principal Investigator |
| Sun Lirong, Ph.D | The Affiliated Hospital of Qingdao University | Principal Investigator |
| Li Aimin, Ph.D | Yantai Yuhuangding Hospital | Principal Investigator |
| Gao Fei, Ph.D | Shandong Proincial Hospital | Principal Investigator |
| Liu Wei, Ph.D | Zhengzhou Children's Hospital | Principal Investigator |
| Liang Changda, Master | Jiangxi Proincial Children's Hospital | Principal Investigator |
| Pan Kaili, Master | Northwest Women's Hospital | Principal Investigator |
| Children's Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 210000 | China |
|
| Shandong Province Qianfoshan Hospital | Recruiting | Jinan | Shandong | 250000 | China |
|
| The Affiliated Hospital of Qingdao University | Recruiting | Qingdao | Shandong | 266000 | China |
|
| Children's Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
|
| Xinhua Hospital affiliated to Shanghai Jiaotong University school of medicine | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
|
| Northwest Women's Hospital | Recruiting | Xi'an | Shangxi | 710000 | China |
|
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D008223 | Lymphoma |
| D009447 | Neuroblastoma |
| D018197 | Hepatoblastoma |
| D012175 | Retinoblastoma |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D018193 | Neoplasms, Complex and Mixed |
| D019572 | Retinal Neoplasms |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D012164 | Retinal Diseases |
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| ID | Term |
|---|---|
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| D016179 | Granulocyte Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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