National Longitudinal Cohort of Hematological Diseases (NICHE)

National Longitudinal Cohort of Hematological Diseases (NICHE)

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.

Study Overview

• Status: Recruiting
• Conditions: Lymphoma; Acute Myeloid Leukemia; Leukemia; Hemophilia A; Hemophilia B; Hemophilia; Multiple Myeloma; Myelodysplastic Syndrome; Bone Marrow Transplantation; MDS; Aplastic Anemia; Bleeding Disorder; Myeloma, Multiple; Myelomas, Multiple; Leukemias, Acute Myeloid; Myeloid Leukemias, Acute; Hemophilia As; Hemophilia Bs; Blood Disease Infection

• Study Type: Observational
• Enrollment (Anticipated): 2300

Contacts and Locations

• Study Contact: Name: Zhen Song, MD; Phone Number: +86 02223909051; Email: cir@ihcams.ac.cn

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300000
      • Recruiting
      • Institute of Hematology & Blood Diseases Hospital
      • Contact: Zhen Song, MD; Phone Number: 022-23909051; Email: songzhen@ihcams.ac.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Institute of Hematology & Blood Diseases Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2030

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 27, 2020

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 23, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Disease Attributes; Bone Marrow Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Paraproteinemias; Blood Protein Disorders; Anemia; Bone Marrow Failure Disorders; Myelodysplastic Syndromes; Hemostatic Disorders; Hemophilia A; Hemophilia B; Blood Coagulation Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Hematologic Diseases; Acute Disease; Anemia, Aplastic
• Other Study ID Numbers: IHBDH-IIT2020025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No