UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014411 |
|---|---|
| Receipt number | R000016765 |
| Scientific Title | Evaluation of oxidative stress markers in hematologic diseases |
| Date of disclosure of the study information | 2014/06/29 |
| Last modified on | 2020/01/04 01:13:19 |
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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
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
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
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
n-tomo@eurus.dti.ne.jp
Sponsor or person
Institute
Yokohama Municipal Citizen's Hospital
Institute
Department
Personal name
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
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.
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 | 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016765
