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NCT Number: NCT04645199

National Longitudinal Cohort of Hematological Diseases

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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Key information

Conditions

Multiple Myeloma Acute Myeloid Leukemia Anemia Anemia, Aplastic Anemia, Hemolytic Anemia, Hemolytic, Autoimmune Aplastic Anemia Autoimmune Diseases Autoimmune Hemolytic Anemia, AIHA Bleeding Disorder Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Blood Disease Infection Blood Platelet Disorders Blood Protein Disorders Bone Marrow Diseases Bone Marrow Failure Disorders Bone Marrow Transplantation Cardiovascular Diseases Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Essential Thrombocythemia, ET Genetic Diseases, Inborn Genetic Diseases, X-Linked Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinuria, Paroxysmal Hemophilia Hemophilia A Hemophilia B Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Large Granular Lymphocyte Leukemia, LGLL Leukemia Leukemia, Large Granular Lymphocytic Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia, T-Cell Lymphatic Diseases Lymphoma Lymphoproliferative Disorders MDS Myelodysplastic Syndrome Myelodysplastic Syndromes Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Paroxysmal Nocturnal Hemoglobinuria, PNH Thrombocythemia, Essential Thrombocytosis Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, 300000, China

Location status: Recruiting

Location contact

Zhen Song, MD

CONTACT

[email protected]

022-23909051

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Incidence and distribution

    Time frame: 5 years

    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.

Secondary outcomes

  1. Therapeutic evaluation

    Time frame: 5 years

    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.

  2. Health economic evaluation

    Time frame: 5 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhen Song, MD

CONTACT

[email protected]

+86 02223909051

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study title

National Longitudinal Cohort of Hematological Diseases (NICHE)

Acronym: NICHE

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Nov 27, 2020
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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