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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

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

Email

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

Email

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

Email

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