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Background Hematological diseases are disorders of the blood and hematopoietic organs. The current hematological cohorts are mostly based on single-center or multi-center cases, or cohorts with limited sample size in China. There is a lack of comprehensive and large-scale prospective cohort studies in hematology. The purpose of this study is to analyze the incidence and risk factors of major blood diseases, the treatment methods, prognosis and medical expenses of these patients in China.
Method The study will include patients diagnosed with acute myeloid leukemia, multiple myeloma, hemophilia, aplastic anemia, leukemia, myelodysplastic syndrome, lymphoma, bleeding disorders, autoimmune hemolytic anemia, large granular lymphocyte leukemia, essential thrombocythemia, blood infection or received bone marrow transplantation in the investigating hospitals from January 1, 2020, and collect basic information, diagnostic and treatment information, prognosis information, as well as medical expense information from medical records. In its current form, the NICHE registry incorporates historical data (collected from 2000) and is systematically collecting prospective data in two phases with broadening reach, and prospectively follow-up to collect the prognosis information.
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence and distribution | To describe the incidence and population characteristics of hematological diseases in China, such as: leukemia, multiple myeloma, hemophilia, aplastic anemia, myelodysplastic syndrome, lymphoma, bleeding disorders, blood disease infection, et al., and analyze the risk factors associated with these diseases. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic evaluation | To analyze the therapeutic efficacy and long-term prognosis of patients with hematological diseases, such as: leukemia, multiple myeloma, hemophilia, aplastic anemia, myelodysplastic syndrome, lymphoma, bleeding disorders, blood disease infection, et al. | 5 years |
| Health economic evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who were diagnosed with acute myeloid leukemia, multiple myeloma, hemophilia, aplastic anemia, leukemia, myelodysplastic syndrome, lymphoma, bleeding disorders or received bone marrow transplantation in the investigating hospitals from January 1, 2020.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhen Song, MD | Contact | +86 02223909051 | cir@ihcams.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital | Recruiting | Tianjin | Tianjin Municipality | 300000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40353947 | Derived | Lu N, Liu L, Cao Y, Zhang R, Zhai W, Chen X, Ma Q, Yang D, Pang A, Wei J, He Y, Feng S, Han M, Jiang E. Efficacy and safety of mitoxantrone hydrochloride liposome-containing regimens in treating refractory/relapsed acute myeloid leukemia. Discov Oncol. 2025 May 12;16(1):727. doi: 10.1007/s12672-025-02526-y. | |
| 39095502 | Derived |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: NICHE-AML | Jul 30, 2020 | Nov 18, 2020 |
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To conduct health economic evaluation on patients with hematological diseases, such as: leukemia, multiple myeloma, hemophilia, aplastic anemia, myelodysplastic syndrome, lymphoma, bleeding disorders, blood disease infection, et al. |
| 5 years |
| Yan W, Shi L, Xu J, Li L, Cui J, Liu Y, Zhou J, Du C, Yu T, Zhang S, Lv R, Sui W, Deng S, Li X, Du X, Xu Y, Zou D, Qiu L, Hao M, An G. Clinical implications of residual normal plasma cells within bone marrow across various disease stages in multiple myeloma. Leukemia. 2024 Oct;38(10):2235-2245. doi: 10.1038/s41375-024-02366-9. Epub 2024 Aug 2. |
| 38505288 | Derived | Gao H, Wang J, Zheng X, Pei X, Zheng Y, Zhai W, Zhang R, Chen X, Ma Q, Wei J, Yang D, Pang A, He Y, Feng S, Cao Y, Jiang E. Ursodeoxycholic acid does not reduce SARS-CoV-2 infection in newly allogeneic hematopoietic stem cell transplantation recipients: a prospective NICHE cohort. Front Cell Infect Microbiol. 2024 Mar 5;14:1324019. doi: 10.3389/fcimb.2024.1324019. eCollection 2024. |
| 38249329 | Derived | Cui J, Yu T, Lv R, Liu J, Fan H, Yan W, Xu J, Du C, Deng S, Sui W, Ho M, Xu Y, Anderson KC, Dong X, Qiu L, An G. Longitudinal genetically detectable minimal residual disease by fluorescence in situ hybridization confers a poor prognosis in myeloma. Ther Adv Med Oncol. 2024 Jan 19;16:17588359231221340. doi: 10.1177/17588359231221340. eCollection 2024. |
| 38170583 | Derived | Fan H, Wang B, Shi L, Pan N, Yan W, Xu J, Gong L, Li L, Liu Y, Du C, Cui J, Zhu G, Deng S, Sui W, Xu Y, Yi S, Hao M, Zou D, Chen X, Qiu L, An G. Monitoring Minimal Residual Disease in Patients with Multiple Myeloma by Targeted Tracking Serum M-Protein Using Mass Spectrometry (EasyM). Clin Cancer Res. 2024 Mar 15;30(6):1131-1142. doi: 10.1158/1078-0432.CCR-23-2767. |
| 37846845 | Derived | Yan W, Xu J, Fan H, Li L, Cui J, Du C, Deng S, Sui W, Xu Y, Hao M, Anderson KC, Zou D, Qiu L, An G. Early relapse within 18 months is a powerful dynamic predictor for prognosis and could revise static risk distribution in multiple myeloma. Cancer. 2024 Feb 1;130(3):421-432. doi: 10.1002/cncr.35056. Epub 2023 Oct 17. |
| 37680953 | Derived | Liu J, Yan W, Fan H, Xu J, Li L, Du C, Mao X, Yan Y, Xu Y, Sui W, Deng S, Yi S, Anderson KC, Qiu L, Zou D, An G. Clinical Benefit of Autologous Stem Cell Transplantation for Patients with Multiple Myeloma Achieving Undetectable Minimal Residual Disease after Induction Treatment. Cancer Res Commun. 2023 Sep 6;3(9):1770-1780. doi: 10.1158/2767-9764.CRC-23-0185. eCollection 2023 Sep. |
| 37534514 | Derived | Cui J, Lv R, Yu T, Yan W, Xu J, Fan H, Li L, Liu Y, Du C, Deng S, Sui W, Xu Y, Yi S, Zou D, Qiu L, An G. Minor clone of del(17p) provides a reservoir for relapse in multiple myeloma. Haematologica. 2024 Feb 1;109(2):591-603. doi: 10.3324/haematol.2023.283533. |
| 36647781 | Derived | Fan H, Wang W, Zhang Y, Wang J, Cheng T, Qiu L, Wang X, Xia Z, An G. Current treatment paradigm and survival outcomes among patients with newly diagnosed multiple myeloma in China: a retrospective multicenter study. Cancer Biol Med. 2023 Jan 12;20(1):77-87. doi: 10.20892/j.issn.2095-3941.2022.0612. |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: NICHE-MM | Jul 30, 2020 | Nov 18, 2020 | Prot_001.pdf |
| Prot | Yes | No | No | Study Protocol: NICHE-Hemophilia | Aug 27, 2020 | Nov 19, 2020 | Prot_002.pdf |
| Prot | Yes | No | No | Study Protocol: NICHE-AA | Dec 4, 2020 | Jun 22, 2021 | Prot_003.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: NICHE-Leukemia/MDS/Lymphoma/BD | Feb 9, 2021 | Dec 21, 2021 | Prot_SAP_004.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: NICHE-BMT/Pediatrics | Dec 15, 2020 | Jan 11, 2022 | Prot_SAP_005.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: NICHE-BDI | Dec 7, 2022 | Mar 8, 2023 | Prot_SAP_007.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: NICHE-AA/Hemophilia/AML/MM_SAP | Dec 4, 2020 | Jan 11, 2022 | SAP_006.pdf |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D015470 | Leukemia, Myeloid, Acute |
| D006467 | Hemophilia A |
| D002836 | Hemophilia B |
| D009190 | Myelodysplastic Syndromes |
| D008223 | Lymphoma |
| D007938 | Leukemia |
| D000741 | Anemia, Aplastic |
| D020141 | Hemostatic Disorders |
| D000744 | Anemia, Hemolytic, Autoimmune |
| D013920 | Thrombocythemia, Essential |
| D054066 | Leukemia, Large Granular Lymphocytic |
| D006457 | Hemoglobinuria, Paroxysmal |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007951 | Leukemia, Myeloid |
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D020147 | Coagulation Protein Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |
| D001855 | Bone Marrow Diseases |
| D008206 | Lymphatic Diseases |
| D000740 | Anemia |
| D000080983 | Bone Marrow Failure Disorders |
| D000743 | Anemia, Hemolytic |
| D001327 | Autoimmune Diseases |
| D013922 | Thrombocytosis |
| D001791 | Blood Platelet Disorders |
| D009196 | Myeloproliferative Disorders |
| D015458 | Leukemia, T-Cell |
| D007945 | Leukemia, Lymphoid |
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