UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010992 |
|---|---|
| Receipt number | 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 | 2021/12/24 09:11:03 |
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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 | 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
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
mmurata@med.nagoya-u.ac.jp
Sponsor or person
Institute
Reserch group for LTFU
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012814
