National Longitudinal Cohort of Hematological Diseases (NICHE)
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| ClinicalTrials.gov Identifier: NCT04645199 |
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Recruitment Status :
Recruiting
First Posted : November 27, 2020
Last Update Posted : January 14, 2022
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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 |
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| 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 Type : | Observational |
| Estimated Enrollment : | 2300 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | National Longitudinal Cohort of Hematological Diseases (NICHE) |
| Actual Study Start Date : | December 1, 2020 |
| Estimated Primary Completion Date : | December 1, 2025 |
| Estimated Study Completion Date : | December 1, 2030 |
- Incidence and distribution [ Time Frame: 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.
- Therapeutic evaluation [ Time Frame: 5 years ]To analyze the therapeutic efficacy and long-term prognosis of patients with acute myeloid leukemia, multiple myeloma, and hemophilia.
- Health economic evaluation [ Time Frame: 5 years ]To conduct health economic evaluation on patients with acute myeloid leukemia, multiple myeloma, and hemophilia.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04645199
| Contact: Zhen Song, MD | +86 02223909051 | cir@ihcams.ac.cn |
| China, Tianjin | |
| Institute of Hematology & Blood Diseases Hospital | Recruiting |
| Tianjin, Tianjin, China, 300000 | |
| Contact: Zhen Song, MD 022-23909051 songzhen@ihcams.ac.cn | |
Documents provided by Chengtao, Institute of Hematology & Blood Diseases Hospital:
| Responsible Party: | Chengtao, Director of Institute of Hematology & Blood Diseases Hospital, Institute of Hematology & Blood Diseases Hospital |
| ClinicalTrials.gov Identifier: | NCT04645199 |
| Other Study ID Numbers: |
IHBDH-IIT2020025 |
| First Posted: | November 27, 2020 Key Record Dates |
| Last Update Posted: | January 14, 2022 |
| Last Verified: | January 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Leukemia Leukemia, Myeloid Multiple Myeloma Neoplasms, Plasma Cell Leukemia, Myeloid, Acute Hemostatic Disorders Myelodysplastic Syndromes Hemophilia A Anemia, Aplastic Hemophilia B Blood Coagulation Disorders Hematologic Diseases Acute Disease Neoplasms by Histologic Type Neoplasms |
Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Bone Marrow Diseases Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Genetic Diseases, Inborn Anemia Bone Marrow Failure Disorders Genetic Diseases, X-Linked |