National Longitudinal Cohort of Hematological Diseases

Официальное название

National Longitudinal Cohort of Hematological Diseases (NICHE)

Обзор

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.

Первичные конечные точки

• Incidence and distribution [Срок оценки: 5 years]

Вторичные конечные точки (2)

• Therapeutic evaluation [Срок оценки: 5 years]
• Health economic evaluation [Срок оценки: 5 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Long-term follow-up information for patients is not available for any reason, such as not being available or having a serious concomitant disease.
• Alcohol and drug addictions affect their ability to comply with study requirements.
• According to the investigator, there are conditions that may endanger the patient's safety or affect his/her compliance.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Institute of Hematology & Blood Diseases Hospital — Тяньцзинь

Публикации

• 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. PMID 40353947
• 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. PMID 39095502
• 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. PMID 38505288
• 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. PMID 38249329
• 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. PMID 38170583
• 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. PMID 37846845
• 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. PMID 37680953
• 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. PMID 37534514

Идентификаторы

NCT: NCT04645199 · NICHE-cohort

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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