UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013087 |
|---|---|
| Receipt number | R000015222 |
| Scientific Title | Epidemiologic cohort study for partial lipodystrophy following hematopoietic stem cell transplantation |
| Date of disclosure of the study information | 2014/02/10 |
| Last modified on | 2017/05/12 17:19:01 |
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Basic information
Public title
Epidemiologic cohort study for partial lipodystrophy following hematopoietic stem cell transplantation
Acronym
lipodystrophy related with hematopoietic stem cell transplantation
Scientific Title
Epidemiologic cohort study for partial lipodystrophy following hematopoietic stem cell transplantation
Scientific Title:Acronym
lipodystrophy related with hematopoietic stem cell transplantation
Region
| Japan |
Condition
Condition
Childhood cancer
Classification by specialty
| Endocrinology and Metabolism | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We recently identified five CCS (Childhood Cancer Survivor) patients who developed partial lipodystrophy following hematopoietic stem cell transplantation (HSCT). Partial lipodystrophy is characterized by unique distribution pattern of subcutaneous fat, visceral fat accumulation, insulin resistance, and dyslipidemia. We infer that HSCT-related subcutaneous fat-cell damage is the main cause for the development of lipodystrophy. It may be the case that many cases have been left undiagnosed, because partial lipodystrophy is hard to recognize and develops decade after HSCT. The object of this study is to investigate the incidence and to figure out some risk factors for partial lipodystrophy following HSCT.
Basic objectives2
Others
Basic objectives -Others
Epidemiologic study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Estimation of the incidence, time of onset, and the pattern of development of partial lipodystrophy in CCS patients following HSCT.
Key secondary outcomes
1. Identification of risk factor(s) for developing partial lipodystrophy following HSCT
2. Investigation of the relationship between partial lipodystrophy and fatty liver
3. Estimation of the incidence of dyslipidemia and impaired glucose tolerance in CCS patients following HSCT
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent HSCT as a treatment for childhood cancer and are in remission
Key exclusion criteria
none
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanori Adachi |
Organization
Kanagawa Children's Medical Center
Division name
Clinical Research Institute / Department of Endocrinology and Metabolism
Zip code
Address
Mutsukawa 2-138-4, Minami-ku, Yokohama, Japan
TEL
+81-45-711-2351
madachi@mars.sannet.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Nakajima |
Organization
Kanagawa Children's Medical Center
Division name
Executive office of Ethical Committee
Zip code
Address
Mutsukawa 2-138-4, Minami-ku, Yokohama, Japan
TEL
+81-45-711-2351
Homepage URL
nakajima.13011@kanagawa-pho.jp
Sponsor or person
Institute
Kanagawa Children's Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
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
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
神奈川県立こども医療センター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5402311/
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
Main results already published
Date of protocol fixation
| 2014 | Year | 01 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 28 | Day |
Date trial data considered complete
| 2016 | Year | 04 | Month | 28 | Day |
Date analysis concluded
| 2016 | Year | 08 | Month | 01 | Day |
Other
Other related information
Related reference
Adachi M, Asakura Y, Muroya K, Goto H, Kigasawa H. Abnormal adipose tissue distribution with unfavorable metabolic profile in five children following hematopoietic stem cell transplantation: A new etiology for acquired partial lipodystrophy. Clin Pediatr Endocrinol. 2013;22:53-64.
Management information
Registered date
| 2014 | Year | 02 | Month | 06 | Day |
Last modified on
| 2017 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015222
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
