UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of marker assoriated with iron and inflammation in allogeneic cell transplantation: multicenter prospecitve study
Title of the study (Brief title)	II-HCT
Region	Japan

Condition
Condition	Hematologic disease
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the prognostic significance of iron and inflammation markers in allogeneic cell transplantation
Basic objectives2	Others
Basic objectives -Others	To evaluated the clinical significance of iron and inflammation markers in post-transplant period.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	overall survival at 2 year according to makers
Key secondary outcomes	(1)disease-free survival, non-relapse mortality, and relapse at 2 year according to makers (2)corelation between ferritin and other markers (3)relation between markers and transplant-related complications

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)age more than 16 year old (2)First allogeneic cell transplantaion (3)acute leukemia, myelodysplastic syndrome, aplastic anemia, chronic leukemia, adult T-cell leukemia/lymphoma, malicnant lynphoma, multiple myeloma (4)informed consent
Key exclusion criteria	(1)history of allogeneic cell transplantation (2) decised unsuitable by associated doctor
Target sample size	140

Research contact person
Name of lead principal investigator	Takayoshi Tachibana
Organization	Yokohama City University
Division name	Internal medicine and clinical immunology
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL	045-787-2800
Email	tcbnt@yokohama-cu.ac.jp

Public contact
Name of contact person	Takayoshi Tachibana
Organization	Yokohama City University
Division name	Internal medicine and clinical immunology
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL	045-787-2800
Homepage URL
Email	tcbnt@yokohama-cu.ac.jp

Sponsor
Institute	Department of Internal Medicine and Clinical Immunology, Yokohama City University Graduate of School of Medicine, Yokohama, Japan
Institute
Department

Funding Source
Organization	NA
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2014 Year 03 Month 25 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 03 Month 20 Day
Anticipated trial start date	2014 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Under registration

Management information
Registered date	2014 Year 03 Month 25 Day
Last modified on	2017 Year 01 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015782