UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Epidemiologic cohort study for partial lipodystrophy following hematopoietic stem cell transplantation
Title of the study (Brief title)	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	Masanori Adachi
Organization	Kanagawa Children's Medical Center
Division name	Clinical Research Institute / Department of Endocrinology and Metabolism
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	Satoshi Nakajima
Organization	Kanagawa Children's Medical Center
Division name	Executive office of Ethical Committee
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 01 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5402311/
Results
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