UMIN-CTR Clinical Trial

Basic information
Public title	A prospective observational study for a validation of National Institutes of Health criteria for late-acute and chronic GVHD (KSGCT1201 / NIH-GVHD STUDY)
Acronym	KSGCT1201 / NIH-GVHD STUDY
Scientific Title	A prospective observational study for a validation of National Institutes of Health criteria for late-acute and chronic GVHD (KSGCT1201 / NIH-GVHD STUDY)
Scientific Title:Acronym	KSGCT1201 / NIH-GVHD STUDY
Region	Japan

Condition
Condition	Allogeneic hematopoietic stem cell transplantation
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Prospectively assess the incidence of late-acute and chronic GVHD by revised NIH criteria (NIH-GVHD) and evaluate the impact of those on the outcome of stem cell transplantation.
Basic objectives2	Others
Basic objectives -Others	Describe the incidence and distribution of NIH-GVHD, and assess whether they predict the mortality and survival.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluate weather global severity of NIH-GVHD associates with GVHD specific survival and the time to immunosuppressant withdrawal.
Key secondary outcomes	Evaluate the association of classification and global severity of NIH-GVHD with following parameters; Overall survival Evaluate the association of classification and global severity of NIH-GVHD with following parameters; Overall survival Non-relapse mortality Relapse rate Incidence of secondary malignancy Cumulative incidence of NIH-GVHD Distribution of organ specific severity Risk factor for the onset of NIH-GVHD Treatment outcome of NIH-GVHD

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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients who undergo allogeneic stem cell transplantation for the first time 2. Age 16 or over at transplantation 3. Provided written informed consent in accordance with the Declaration of Helsinki.
Key exclusion criteria	Patients without written informed consent.
Target sample size	400

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Shinichiro Okamoto
Organization	Kanto Study Group for Cell Therapy
Division name	Chairman
Zip code
Address	Tokyo
TEL	03-6225-2040
Email	ksgctdc@ksgct.net

Public contact
1st name of contact person	1st name Middle name Last name Chikako Ohwada
Organization	Kanto Study Group for Cell Therapy
Division name	Trial Office
Zip code
Address	rm.B 4nd fl. Heiwa Building, 3-3-13, Kyobashi, Chuo-ku, Tokyo, 104-0031, Japan
TEL	03-6225-2040
Homepage URL
Email	chikako_ohwada@faculty.chiba-u.jp

Sponsor
Institute	Kanto Study Group for Cell Therapy
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	2012 Year 04 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	Completed
Date of protocol fixation	2012 Year 03 Month 07 Day
Date of IRB	2012 Year 03 Month 09 Day
Anticipated trial start date	2012 Year 04 Month 01 Day
Last follow-up date	2017 Year 04 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	NIH-GVHD

Management information
Registered date	2012 Year 04 Month 20 Day
Last modified on	2019 Year 04 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009183