National Longitudinal Cohort of Hematological Diseases

NCT04645199 | Recruiting

• 1 other identifier: NICHE-cohort
• Study Type: observational
• Target: 2,300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Leukemia; Aplastic Anemia; Bone Marrow Transplantation; Paroxysmal Nocturnal Hemoglobinuria, PNH; Multiple Myeloma; Acute Myeloid Leukemia; Hemophilia; Hemophilia A; Hemophilia B; Myelodysplastic Syndrome; MDS; Lymphoma; Bleeding Disorder; Blood Disease Infection; Autoimmune Hemolytic Anemia, AIHA; Essential Thrombocythemia, ET; Large Granular Lymphocyte Leukemia, LGLL

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Therapeutic evaluation

  5 years

• Health economic evaluation

  5 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

Related Publications (8)

• 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 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.

  PMID: 38505288 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.

  PMID: 38249329 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.

  PMID: 38170583 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.

  PMID: 37846845 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.

  PMID: 37680953 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.

  PMID: 37534514 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.

  PMID: 36647781 DERIVED

MeSH Terms

Conditions

Multiple Myeloma; Leukemia, Myeloid, Acute; Hemophilia A; Hemophilia B; Myelodysplastic Syndromes; Lymphoma; Leukemia; Anemia, Aplastic; Hemostatic Disorders; Anemia, Hemolytic, Autoimmune; Thrombocythemia, Essential; Leukemia, Large Granular Lymphocytic; Hemoglobinuria, Paroxysmal

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid; Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Coagulation Protein Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked; Bone Marrow Diseases; Lymphatic Diseases; Anemia; Bone Marrow Failure Disorders; Anemia, Hemolytic; Autoimmune Diseases; Thrombocytosis; Blood Platelet Disorders; Myeloproliferative Disorders; Leukemia, T-Cell; Leukemia, Lymphoid

Central Study Contacts

Zhen Song, MD

CONTACT

+86 02223909051; cir@ihcams.ac.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 27, 2020
• Study Start: December 1, 2020
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 12, 2026

Record last verified: 2025-12

Locations

CN (1)