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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030023
Receipt No. R000034282
Scientific Title Multicenter cohort study on late complications of Langerhans cell histiocytosis patients
Date of disclosure of the study information 2017/11/20
Last modified on 2017/11/17

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Basic information
Public title Multicenter cohort study on late complications of Langerhans cell histiocytosis patients
Acronym Observational study on late complication of LCH
Scientific Title Multicenter cohort study on late complications of Langerhans cell histiocytosis patients
Scientific Title:Acronym Observational study on late complication of LCH
Region
Japan

Condition
Condition Langerhans cell histiocytosis
Classification by specialty
Pediatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the incidence, clinical courses and risk factors of late complications in patients with Langerhans cell histiocytosis (LCH) by long term follow-up.
Basic objectives2 Others
Basic objectives -Others To clarify the incidence, clinical courses and risk factors of late complications in LCH patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of late complications over time
Key secondary outcomes Risk factors for late complications
Evaluation of clinical course of central nervous degenerative LCH

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 were diagnosed as LCH between 1996 and 2009, and have been followed up at the facility participating in the Japan LCH Study Group.
Key exclusion criteria 1. Patients who are not proved to have LCH by histological examination
2. Patients who died within 3 years after diagnosis
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Morimoto
Organization Jichi Medical University
Division name Pediatrics
Zip code
Address 3311-1, Yakushiji, Shimotsuke, Tochigi
TEL 0285-58-7366
Email akira@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Morimoto
Organization Jichi Medical University
Division name Pediatrics
Zip code
Address 3311-1, Yakushiji, Shimotsuke, Tochigi
TEL 0285-58-7366
Homepage URL http://www.jlsg.jp/c_research/for_patients.html
Email info@jlsg.jp

Sponsor
Institute Japan LCH Study Group
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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
2017 Year 11 Month 20 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 Enrolling by invitation
Date of protocol fixation
2016 Year 03 Month 22 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design: cohort study
How to recruit subjects: All patients who are followed by the facility and meet the inclusion criteria
Items to be measured: presence or absence of late complications, presence or absence of recurrence, presence or absence of active lesions, recurrence, survival data, radiologic image findings, clinical symptoms, performance status

Management information
Registered date
2017 Year 11 Month 17 Day
Last modified on
2017 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034282

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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