Clinical trial NCT04645199: National Longitudinal Cohort of Hematological Diseases
Official title: National Longitudinal Cohort of Hematological Diseases (NICHE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
Blood Disease Infection
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2020-11-27
Enrollment: 2300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence and distribution
timeFrame: 5 years
Secondary outcomes:
measure: Therapeutic evaluation
timeFrame: 5 years
measure: Health economic evaluation
timeFrame: 5 years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital
state: Tianjin
Study officials:
References: