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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000013087
Receipt No. 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

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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
Email 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
Email nakajima.13011@kanagawa-pho.jp

Sponsor
Institute Kanagawa Children's Medical Center
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015222

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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