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RecruitingNCT04645199NICHEUpdated Feb 12, 2026

National Longitudinal Cohort of Hematological Diseases

An observational study in Multiple Myeloma, Acute Myeloid Leukemia and Hemophilia, sponsored by Institute of Hematology & Blood Diseases Hospital, China. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-02-12.

Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Observational

From the registry’s dates

  • Started Dec 2020; still recruiting 5 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,300
Sex
All
01

Study 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, autoimmune hemolytic anemia, large granular lymphocyte leukemia, essential thrombocythemia, 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.

02

Conditions studied

  • Multiple Myeloma
  • Acute Myeloid Leukemia
  • Hemophilia
  • Hemophilia A
  • Hemophilia B
  • Myelodysplastic Syndrome
  • MDS
  • Lymphoma
  • Leukemia
  • Aplastic Anemia
  • Bleeding Disorder
  • Bone Marrow Transplantation
  • Blood Disease Infection
  • Autoimmune Hemolytic Anemia, AIHA
  • Essential Thrombocythemia, ET
  • Large Granular Lymphocyte Leukemia, LGLL
  • Paroxysmal Nocturnal Hemoglobinuria, PNH
03

In context

Multiple Myeloma

3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.

This study's planned enrollment of 2,300 is above the median of 150 across 486 observational studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China is the lead sponsor of 410 studies on the registry; 291 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,300 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 5 years

Secondary outcomes

  1. 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.

    Time frame: 5 years

  2. 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.

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Lu N, Liu L, Cao Y, Zhang R, Zhai W, Chen X, Ma Q, Yang D, Pang A, Wei J, He Y, Feng S, Han M, Jiang E. Efficacy and safety of mitoxantrone hydrochloride liposome-containing regimens in treating refractory/relapsed acute myeloid leukemia. Discov Oncol. 2025 May 12;16(1):727. doi: 10.1007/s12672-025-02526-y. PubMed 40353947 ↗
  • Yan W, Shi L, Xu J, Li L, Cui J, Liu Y, Zhou J, Du C, Yu T, Zhang S, Lv R, Sui W, Deng S, Li X, Du X, Xu Y, Zou D, Qiu L, Hao M, An G. Clinical implications of residual normal plasma cells within bone marrow across various disease stages in multiple myeloma. Leukemia. 2024 Oct;38(10):2235-2245. doi: 10.1038/s41375-024-02366-9. Epub 2024 Aug 2. PubMed 39095502 ↗
  • Gao H, Wang J, Zheng X, Pei X, Zheng Y, Zhai W, Zhang R, Chen X, Ma Q, Wei J, Yang D, Pang A, He Y, Feng S, Cao Y, Jiang E. Ursodeoxycholic acid does not reduce SARS-CoV-2 infection in newly allogeneic hematopoietic stem cell transplantation recipients: a prospective NICHE cohort. Front Cell Infect Microbiol. 2024 Mar 5;14:1324019. doi: 10.3389/fcimb.2024.1324019. eCollection 2024. PubMed 38505288 ↗
  • Cui J, Yu T, Lv R, Liu J, Fan H, Yan W, Xu J, Du C, Deng S, Sui W, Ho M, Xu Y, Anderson KC, Dong X, Qiu L, An G. Longitudinal genetically detectable minimal residual disease by fluorescence in situ hybridization confers a poor prognosis in myeloma. Ther Adv Med Oncol. 2024 Jan 19;16:17588359231221340. doi: 10.1177/17588359231221340. eCollection 2024. PubMed 38249329 ↗
  • Fan H, Wang B, Shi L, Pan N, Yan W, Xu J, Gong L, Li L, Liu Y, Du C, Cui J, Zhu G, Deng S, Sui W, Xu Y, Yi S, Hao M, Zou D, Chen X, Qiu L, An G. Monitoring Minimal Residual Disease in Patients with Multiple Myeloma by Targeted Tracking Serum M-Protein Using Mass Spectrometry (EasyM). Clin Cancer Res. 2024 Mar 15;30(6):1131-1142. doi: 10.1158/1078-0432.CCR-23-2767. PubMed 38170583 ↗
  • Yan W, Xu J, Fan H, Li L, Cui J, Du C, Deng S, Sui W, Xu Y, Hao M, Anderson KC, Zou D, Qiu L, An G. Early relapse within 18 months is a powerful dynamic predictor for prognosis and could revise static risk distribution in multiple myeloma. Cancer. 2024 Feb 1;130(3):421-432. doi: 10.1002/cncr.35056. Epub 2023 Oct 17. PubMed 37846845 ↗
  • Liu J, Yan W, Fan H, Xu J, Li L, Du C, Mao X, Yan Y, Xu Y, Sui W, Deng S, Yi S, Anderson KC, Qiu L, Zou D, An G. Clinical Benefit of Autologous Stem Cell Transplantation for Patients with Multiple Myeloma Achieving Undetectable Minimal Residual Disease after Induction Treatment. Cancer Res Commun. 2023 Sep 6;3(9):1770-1780. doi: 10.1158/2767-9764.CRC-23-0185. eCollection 2023 Sep. PubMed 37680953 ↗
  • Cui J, Lv R, Yu T, Yan W, Xu J, Fan H, Li L, Liu Y, Du C, Deng S, Sui W, Xu Y, Yi S, Zou D, Qiu L, An G. Minor clone of del(17p) provides a reservoir for relapse in multiple myeloma. Haematologica. 2024 Feb 1;109(2):591-603. doi: 10.3324/haematol.2023.283533. PubMed 37534514 ↗
  • Fan H, Wang W, Zhang Y, Wang J, Cheng T, Qiu L, Wang X, Xia Z, An G. Current treatment paradigm and survival outcomes among patients with newly diagnosed multiple myeloma in China: a retrospective multicenter study. Cancer Biol Med. 2023 Jan 12;20(1):77-87. doi: 10.20892/j.issn.2095-3941.2022.0612. PubMed 36647781 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2020 (actual). Primary completion is estimated for Dec 2030, 120 months after the start.

Of 173 non-industry observational studies under Multiple Myeloma, half reached primary completion within 70 months of starting (the median), counting those still running; a quarter within 33. This study's planned 120 months is above that.

Counting every sponsor, half of 239 studies reached it within 61 months; a quarter within 30 and three quarters within 126.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 13, 2020
First posted
Nov 27, 2020
StartActual
Dec 1, 2020
Primary completionEst.
Dec 1, 2030
CompletionEst.
Dec 1, 2030
Last update
Feb 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04645199
Responsible party
Sponsor
First posted
Nov 27, 2020
Start date
Dec 1, 2020
Primary completion
Dec 1, 2030 (estimated)
Completion
Dec 1, 2030 (estimated)
Last update
Feb 12, 2026

Study contacts

Zhen Song, MD
Contact
cir@ihcams.ac.cn
+86 02223909051

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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