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National Longitudinal Cohort of Hematological Diseases

National Longitudinal Cohort of Hematological Diseases (NICHE)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04645199
Acronym
NICHE
Enrollment
2300
Registered
2020-11-27
Start date
2020-12-01
Completion date
2030-12-01
Last updated
2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Sponsors

Institute of Hematology & Blood Diseases Hospital, China
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence and distribution5 yearsTo 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

MeasureTime frameDescription
Therapeutic evaluation5 yearsTo 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.
Health economic evaluation5 yearsTo 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.

Countries

China

Contacts

CONTACTZhen Song, MD
cir@ihcams.ac.cn+86 02223909051

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026