UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of oxidative stress markers in hematologic diseases
Acronym	Evaluation of oxidative stress markers in hematologic diseases
Scientific Title	Evaluation of oxidative stress markers in hematologic diseases
Scientific Title:Acronym	Evaluation of oxidative stress markers in hematologic diseases
Region	Japan

Condition
Condition	Hematologic diseases
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	to evaluate the usefulness of oxidative stress markers as novel biomarkers in hematologic diseases.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	comparison of oxidative stress marker levels between healthy control and patients with hematologic diseases.
Key secondary outcomes	1)relationship between oxidative stress markers and various prognostic factors. 2)relationship between oxidative stress markers and response rare(RR). 3)relationship between oxidative stress markers and overall survival.

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
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Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	newly diagnosed patients with hematologic diseases. healthy volunteers as normal control.
Key exclusion criteria	1)Patients with double cancer. 2)Patients with severe active infection. 3)Patients with urinary tract infection. 4)Patients with gross hematuria. 5)Patients with severe mental disorder. 6)Patients who are considered unsuitable for the study by attending physician.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tomonori Nakazato
Organization	Yokohama Municipal Citizen's Hospital
Division name	Department of Hematology
Zip code
Address	56 Okazawacho, Hodogaya-ku, Yokohama, Kanagawa
TEL	045-331-1961
Email	n-tomo@eurus.dti.ne.jp

Public contact
Name of contact person	1st name Middle name Last name Tomonori Nakazato
Organization	Yokohama Municipal Citizen's Hospital
Division name	Department of Hematology
Zip code
Address	56 Okazawacho, Hodogaya-ku, Yokohama, Kanagawa
TEL	045-331-1961
Homepage URL
Email	n-tomo@eurus.dti.ne.jp

Sponsor
Institute	Yokohama Municipal Citizen's Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
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IRB Contact (For public release)
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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	横浜市立市民病院

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 29 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	Oxidative stress marker levels in patients with hematologic diseases were significantly elevated compared with normal controls.
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Baseline Characteristics
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IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 01 Month 30 Day
Date of IRB	2012 Year 01 Month 16 Day
Anticipated trial start date	2012 Year 02 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Oxidative stress marker levels in patients with hematologic diseases were significantly elevated compared with normal controls.

Management information
Registered date	2014 Year 06 Month 28 Day
Last modified on	2020 Year 01 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016765

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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