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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028975
Receipt No. R000033086
Scientific Title A longitudinal study of quality of life in hematopoietic stem cell transplant recipients
Date of disclosure of the study information 2017/09/02
Last modified on 2021/03/25

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Basic information
Public title A longitudinal study of quality of life in hematopoietic stem cell transplant recipients
Acronym A longitudinal study of quality of life in hematopoietic stem cell transplant recipients
Scientific Title A longitudinal study of quality of life in hematopoietic stem cell transplant recipients
Scientific Title:Acronym A longitudinal study of quality of life in hematopoietic stem cell transplant recipients
Region
Japan

Condition
Condition Hematological disorders
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The longitudinal evaluation of QOL and the identification of factors affecting QOL in hematopoietic stem cell transplant recipients
Basic objectives2 Others
Basic objectives -Others QOL
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes QOL changes over time after hematopoietic stem cell transplantation
Key secondary outcomes Factors affecting QOL after hematopoietic stem cell transplantation

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Adult hematological patients who underwent hematopoietic stem cell transplantation at Toranomon Hospital
2. Patients who can answer the QOL questionnaire written in Japanese
3. Patients from whom written informed consent has been obtained
Key exclusion criteria Patients who are deemed ineligible by the treating physician
Target sample size 700

Research contact person
Name of lead principal investigator
1st name Shuichi
Middle name
Last name Taniguchi
Organization Toranomon Hospital
Division name Department of Hematology
Zip code 105-8470
Address 2-2-2, Toranomon, Minato-ku, Tokyo, 105-8470, Japan
TEL 03-3588-1111
Email taniguchi-s@toranomon.gr.jp

Public contact
Name of contact person
1st name Yuki
Middle name
Last name Asano-Mori
Organization Toranomon Hospital
Division name Department of Hematology
Zip code 105-8470
Address 2-2-2, Toranomon, Minato-ku, Tokyo, 105-8470, Japan
TEL 03-3588-1111
Homepage URL
Email yukia-tky@umin.net

Sponsor
Institute Toranomon Hospital
Institute
Department

Funding Source
Organization Okinaka Memorial Institute for Medical Research
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Family Nursing, Division of Health Science and Nursing, Graduate School of Medicine, The University of Tokyo
Name of secondary funder(s)

IRB Contact (For public release)
Organization Department of Clinical Trial and Research
Address 2-2-2, Toranomon, Minato-ku, Tokyo, 105-8470, Japan
Tel 03-3588-1111
Email chiken-jim@toranomon.gr.jp

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
2017 Year 09 Month 02 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2010 Year 05 Month 17 Day
Date of IRB
2010 Year 05 Month 17 Day
Anticipated trial start date
2010 Year 07 Month 12 Day
Last follow-up date
2022 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A single-center longitudinal study, to analyze QOL changes over time and factors associated with QOL after hematopoietic stem cell transplantation

Management information
Registered date
2017 Year 09 Month 02 Day
Last modified on
2021 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033086

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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