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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010992
Receipt No. R000012814
Scientific Title Observational study on late effects and quality of life (QOL) in long-term survivors after allogeneic hematopoietic stem cell transplantation.
Date of disclosure of the study information 2013/06/19
Last modified on 2018/08/15

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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
Middle name
Last name Makoto Murata
Organization Nagoya University Hospital
Division name Department of Hematology
Zip code
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
Middle name
Last name Makoto Murata
Organization Nagoya University Hospital
Division name Department of Hematology
Zip code
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
Address
Tel
Email

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
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
2018 Year 08 Month 15 Day


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

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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