UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Cohort study to investigate the clinical factors associated with the prognosis of high risk myelodysplastic syndrome (MDS) and MDS/secondary AML
Title of the study (Brief title)	Cohort study for the prognosis of high risk MDS and MDS/secondary AML
Region	Japan

Condition
Condition	High risk myelodysplastic syndrome and MDS/secondary AML
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To analyze the various factors associated with the prognosis of high risk MDS and MDS/secondary AML
Basic objectives2	Others
Basic objectives -Others	Survival limiting factors
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Efficacy of allo-stem cell transplantation in the survival of high risk MDS and MDS/secondary AML
Key secondary outcomes

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	15 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with high risk MDS and MDS/secondary AML Age above 15 years old
Key exclusion criteria	none
Target sample size	250

Research contact person
Name of lead principal investigator	Mitsuhiro Matsuda, MD, PhD
Organization	Kinki University School of Medicine
Division name	Department of Hematology
Address	377-2 Ohno-Higashi, Osaka-Sayama, Osaka
TEL	072-366-0221
Email

Public contact
Name of contact person	Mitsuhiro Matsuda, MD, PhD
Organization	JALSG MDS206 study office
Division name	Department of Hematology, Kinki University School of Medicine
Address	377-2 Ohno-Higashi, Osaka-Sayama, Osaka
TEL	072-366-0221
Homepage URL
Email	mmatsuda@med.kindai.ac.jp

Sponsor
Institute	Japan Adult Leukemia Study Group
Institute
Department

Funding Source
Organization	Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2006 Year 04 Month 17 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2006 Year 04 Month 05 Day
Anticipated trial start date	2006 Year 04 Month 05 Day
Last follow-up date	2011 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	The aim of this study is to analyze the various clinical factors such as chemotherapy, stem cell transplantation associated with the prognosis of high risk MDS and MDS/secondary MDS.

Management information
Registered date	2006 Year 04 Month 08 Day
Last modified on	2018 Year 10 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000459