UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030023 |
|---|---|
| Receipt number | 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 | 2022/05/23 16:59:15 |
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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 | Akira |
| Middle name | |
| Last name | Morimoto |
Organization
Jichi Medical University
Division name
Pediatrics
Zip code
329-0498
Address
3311-1, Yakushiji, Shimotsuke, Tochigi
TEL
0285-58-7366
akira@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Morimoto |
Organization
Jichi Medical University
Division name
Pediatrics
Zip code
3290498
Address
3311-1, Yakushiji, Shimotsuke, Tochigi
TEL
0285-58-7366
Homepage URL
http://www.jlsg.jp/c_research/for_patients.html
info@jlsg.jp
Sponsor or person
Institute
Japan LCH Study Group
Institute
Department
Personal name
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
Section of Research Support, Jichi Medical University
Address
3311-1Yakushiji, Shimotsuke, Tochigi
Tel
0285442111
shien@jichi.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
| 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
| 2022 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034282
| 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 |
