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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030447
Receipt No. R000034763
Scientific Title Detection of new biomarker for genitourinary diseases by metabolomics
Date of disclosure of the study information 2017/12/25
Last modified on 2018/12/19

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Basic information
Public title Detection of new biomarker for genitourinary diseases by metabolomics
Acronym Detection of new biomarker in blood and urine for genitourinary diseases by metabolomics
Scientific Title Detection of new biomarker for genitourinary diseases by metabolomics
Scientific Title:Acronym Detection of new biomarker in blood and urine for genitourinary diseases by metabolomics
Region
Japan

Condition
Condition genitourinary diseases
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To detect new biomarkers of genitourinary diseases (kidney cancer, prostate cancer, bladder cancer, testicular cancer and adrenal cancer), we investigate metabolites of blood and urine between normal volunteers and patients.
Basic objectives2 Others
Basic objectives -Others metabolomics by the mass analyzer
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of metabolites including blood and urine with normal volunteers and patients with genitourinary diseases
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Normal volunteers and patients with genitourinary diseases (kidney cancer, prostate cancer, bladder cancer, tesuticular cancer and adrenal tumors) who approved storing thier blood and urine for our studies
Key exclusion criteria Those who did not approve storing thier blood and urine for our studies
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshhide Kawasaki
Organization Tohoku University Graduate School of Medicine
Division name Department of Urology
Zip code
Address Seiryo-Machi 1-1 Aoba-Ku Sendai
TEL 022-717-7278
Email kawasaki@uro.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihide Kawasaki
Organization Tohoku University Graduate School of Medicine
Division name Department of Urology
Zip code
Address Seiryo-Machi 1-1 Aoba-Ku Sendai
TEL 022-717-7278
Homepage URL
Email kawasaki@uro.med.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization Self funding
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
Email

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
2017 Year 12 Month 25 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
Our study is going ahead on schedule with sufficient enrolled patients. Currently some pilot analyses for thsese patients have been done to obtain research results.
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 Enrolling by invitation
Date of protocol fixation
2017 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We will diclose the final results as soon as possible.

Management information
Registered date
2017 Year 12 Month 18 Day
Last modified on
2018 Year 12 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034763

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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