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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04645199
Other study ID # IHBDH-IIT2020025
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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