UMIN-CTR Clinical Trial

Basic information
Public title	Observational study on late effects and quality of life (QOL) in long-term survivors after allogeneic hematopoietic stem cell transplantation.
Acronym	Observational study on LTFU
Scientific Title	Observational study on late effects and quality of life (QOL) in long-term survivors after allogeneic hematopoietic stem cell transplantation.
Scientific Title:Acronym	Observational study on LTFU
Region	Japan

Condition
Condition	Hematopoietic stem cell trans- plantation targeted diseases such as hematological diseases
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To prevent, diagnose, and treat early organ dysfunction and late effects after transplantation by analyzing incidence and risk factors of them and to improve QOL in long-term survivors with allogeneic hematopoietic stem cell transplantation.
Basic objectives2	Others
Basic objectives -Others	QOL
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	(1)Incidence and risk factors of organ dysfunction and late effects in long-term survivors after transplantation. (2)Changes of QOL in long-term survivors after transplantation. (3) Influence of organ dysfunction and late effects on QOL and life in patients after transplantation.
Key secondary outcomes

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)Patients who were first transplanted from January 2010.(Patients past of autologous transplantation history in is possible registration, autologous transplantation does not count.) (2)Patients who survived for 150 days and above after last transplantation without relapse at study. (3)Patients who aged 20 or above at transplantation. (4)Patients who were accounted for this study in detail and signed a written informed consents.
Key exclusion criteria	(1) Patients who were unable to read, understand, or reply to FACT-BMT, SF-36, and the questionnaire about life and social environment. (2) Patients who are disqualified by their attending physician.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Last name Murata
Organization	Nagoya University Hospital
Division name	Department of Hematology
Zip code	466-8550
Address	65 Tsurumai-cho, Showa-ku, Nagoya, 466-0065, Japan
TEL	052-744-2145
Email	mmurata@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Murata
Organization	Nagoya University Hospital
Division name	Department of Hematology
Zip code	466-8550
Address	65 Tsurumai-cho, Showa-ku, Nagoya, 466-0065, Japan
TEL	052-744-2145
Homepage URL
Email	mmurata@med.nagoya-u.ac.jp

Sponsor
Institute	Reserch group for LTFU
Institute
Department

Funding Source
Organization	Nagoya BMT Group
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Nagoya University
Address	65 Tsurumai, Showa, Nagoya
Tel	052-744-2423
Email	ethics@med.nagoya-u.ac.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	2013 Year 06 Month 19 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	2013 Year 06 Month 04 Day
Date of IRB	2013 Year 05 Month 13 Day
Anticipated trial start date	2013 Year 06 Month 05 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	multicenter, observational study

Management information
Registered date	2013 Year 06 Month 18 Day
Last modified on	2021 Year 12 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012814