National Longitudinal Cohort of Hematological Diseases

Recruiting

• Conditions: Myeloid Leukemias, Acute; MDS; Lymphoma; Blood Disease Infection; Leukemias, Acute Myeloid; Hemophilia As; Hemophilia Bs; Bone Marrow Transplantation; Myeloma, Multiple; Myelomas, Multiple

• Registration Number: NCT04645199
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

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, 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-13
• Study First Submitted QC: 2020-11-19
• Study First Posted: 2020-11-27
• Study Start: 2020-12-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11
• Primary Completion: 2025-12-01
• Study Completion: 2030-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence and distribution	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 Outcome Measures

Name	Time	Method
Therapeutic evaluation	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.
Health economic evaluation	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.

Trial Locations

Locations (1)

Institute of Hematology & Blood Diseases Hospital; 🇨🇳 Tianjin, Tianjin, China