National Longitudinal Cohort of Hematological Diseases

NCT ID: NCT04645199

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-01

Study Completion Date

2030-12-01

Brief Summary

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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, 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.

Detailed Description

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Conditions

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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 Blood Disease Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhen Song, MD

Role: CONTACT

Phone: +86 02223909051

Email: [email protected]

Facility Contacts

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Zhen Song, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 40353947 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38505288 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38249329 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38170583 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37846845 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37680953 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37534514 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36647781 (View on PubMed)

Provided Documents

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Document Type: Study Protocol: NICHE-AML

View Document

Document Type: Study Protocol: NICHE-MM

View Document

Document Type: Study Protocol: NICHE-Hemophilia

View Document

Document Type: Study Protocol: NICHE-AA

View Document

Document Type: Study Protocol and Statistical Analysis Plan: NICHE-Leukemia/MDS/Lymphoma/BD

View Document

Document Type: Study Protocol and Statistical Analysis Plan: NICHE-BMT/Pediatrics

View Document

Document Type: Study Protocol and Statistical Analysis Plan: NICHE-BDI

View Document

Document Type: Statistical Analysis Plan: NICHE-AA/Hemophilia/AML/MM_SAP

View Document

Other Identifiers

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NICHE-cohort

Identifier Type: -

Identifier Source: org_study_id