National Longitudinal Cohort of Hematological Diseases

Multiple Myeloma Clinical Trial

— NICHE  

Official title:

National Longitudinal Cohort of Hematological Diseases (NICHE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04645199
• Other study ID #: IHBDH-IIT2020025
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: December 1, 2030

Study information

• Verified date: April 2023
• Source: Institute of Hematology & Blood Diseases Hospital
• Contact: Zhen Song, MD
• Phone: +86 02223909051
• Email: cir[@]ihcams.ac.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 or received bone marrow transplantation in the investigating hospitals from January 1, 2020, and collect basic information, diagnostic and treatment 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. The study will use questionnaire to measure the exposure of patients, and prospectively follow-up to collect the prognosis information.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2300
• Est. completion date: December 1, 2030
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Disease
• Acute Myeloid Leukemia
• Anemia, Aplastic
• Aplastic Anemia
• Bleeding Disorder
• Blood Coagulation Disorders
• Bone Marrow Transplantation
• Hematologic Diseases
• Hemophilia
• Hemophilia A
• Hemophilia As
• Hemophilia B
• Hemophilia Bs
• Hemostatic Disorders
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Leukemias, Acute Myeloid
• Lymphoma
• MDS
• Multiple Myeloma
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Myeloid Leukemias, Acute
• Myeloma, Multiple
• Myelomas, Multiple
• Neoplasms, Plasma Cell

Locations

Country	Name	City	State
China	Institute of Hematology & Blood Diseases Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Hematology & Blood Diseases Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Therapeutic evaluation	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.	5 years
Secondary	Health economic evaluation	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.	5 years