NICHE: National Longitudinal Cohort of Hematological Diseases

Sponsor

Institute of Hematology & Blood Diseases Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04645199

Collaborator

(none)

2,300

Enrollment

Location

120

Anticipated Duration (Months)

19.2

Patients Per Site Per Month

Study Details

Study Description

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 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. The study will use questionnaire to measure the exposure of patients, and prospectively follow-up to collect the prognosis information.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma Myeloma, Multiple Myelomas, Multiple Acute Myeloid Leukemia Leukemias, Acute Myeloid Myeloid Leukemias, Acute Hemophilia Hemophilia A Hemophilia As Hemophilia B Hemophilia Bs Myelodysplastic Syndrome MDS Lymphoma Leukemia Aplastic Anemia Bleeding Disorder Bone Marrow Transplantation

Study Design

Study Type:

Observational

Anticipated Enrollment :

2300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

National Longitudinal Cohort of Hematological Diseases (NICHE)

Actual Study Start Date :

Dec 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2030

Outcome Measures

Primary Outcome Measures

Incidence and distribution [5 years]
To describe the incidence and population characteristics of acute myeloid leukemia, multiple myeloma, and hemophilia in China, and analyze the risk factors associated with these diseases.

Secondary Outcome Measures

Therapeutic evaluation [5 years]
To analyze the therapeutic efficacy and long-term prognosis of patients with acute myeloid leukemia, multiple myeloma, and hemophilia.
Health economic evaluation [5 years]
To conduct health economic evaluation on patients with acute myeloid leukemia, multiple myeloma, and hemophilia.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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,

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.