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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000014411 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Hematologic diseases | |
Classification by specialty |
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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 | |
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Interventions/Control_6 | |
Interventions/Control_7 | |
Interventions/Control_8 | |
Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | newly diagnosed patients with hematologic diseases.
healthy volunteers as normal control. |
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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. |
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Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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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 | |
Registered date | File name |
Research case data | |
Registered date | File name |