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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014412
Receipt No. R000016766
Scientific Title Evaluation of oxidative stress markers in hematopoietic stem cell transplantation patients
Date of disclosure of the study information 2014/06/29
Last modified on 2020/01/04

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Basic information
Public title Evaluation of oxidative stress markers in hematopoietic stem cell transplantation patients
Acronym Oxidative stress in HCT
Scientific Title Evaluation of oxidative stress markers in hematopoietic stem cell transplantation patients
Scientific Title:Acronym Oxidative stress in HCT
Region
Japan

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

Objectives
Narrative objectives1 to clarify the significance of oxidative stress markers in hematopoietic stem cell transplantation patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes relationship between oxidative stress markers and GVHD.
Key secondary outcomes 1) relationship between oxidative stress markers and other transplant-related complications.
2) relationship between oxidative stress markers and survival
3) relationship between oxidative stress markers and transplant-related mortality (TRM).
4) relationship between oxidative stress markers and total body irradiation (TBI).

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Candidates for hematopoietic stem cell transplantation.
Key exclusion criteria Patients who could not obtain written consent.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Tomonori
Middle name
Last name Nakazato
Organization Yokohama Municipal Citizen's Hospital
Division name Department of Hematology
Zip code 2408555
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 Tomonori
Middle name
Last name Nakazato
Organization Yokohama Municipal Citizen's Hospital
Division name Department of Hematology
Zip code 2408555
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
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Yokohama Municipal Citizen's Hospital
Address 56 Okazawa-cho, Hodogaya-ku, Yokohama, Japan
Tel 0453311961
Email n-tomo@eurus.dti.ne.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 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 http://yokohama-shiminhosp.jp/
Publication of results Published

Result
URL related to results and publications http://yokohama-shiminhosp.jp/
Number of participants that the trial has enrolled 32
Results 19 male and 13 female patients with a median age of 58 years.
In 20 allo-HSCT patients, the urinary 8-OHdG levels at 1 week after the transplant were significantly higher than the pre-conditioning levels and the levels in healthy controls. In 12 auto-HSCT patients, the urinary 8-OHdG levels at Week 1 were also higher than the pre-conditioning levels. The relative increase in the urinary-8OHdG levels from pre- to post-transplant at Week 1 was associated with a poor overall survival in the allo-HSCT patients.
Results date posted
2020 Year 01 Month 04 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics The patients were 19 male and 13 female patients with a median age of 58 years (27-68 years). Twenty patients received allogeneic HSCT and 12 patients received autologous HSCT.
Participant flow After informed consent was obatained from each patient, urine samples were collected
We measured urinary 8-hydroxydeoxyguanosine (8-OHdG) by competitive immunochromatography using a novel automatic oxidative stress analyzer, ICR-001.
Adverse events none
Outcome measures 1-year OS, high 8-OHdG group: 12.5% vs. low 8-OHdG group: 60.0%; P=0.005.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 08 Month 23 Day
Date of IRB
2012 Year 01 Month 16 Day
Anticipated trial start date
2012 Year 02 Month 14 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
2015 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information serum and urine oxidative stress markers are measured before and after hematopoietic stem cell transplantation.

Management information
Registered date
2014 Year 06 Month 29 Day
Last modified on
2020 Year 01 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016766

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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