UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030447 |
|---|---|
| Receipt number | 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 | 2022/12/22 10:13:34 |
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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 | Yoshhide |
| Middle name | |
| Last name | Kawasaki |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Urology
Zip code
9808574
Address
Seiryo-Machi 1-1 Aoba-Ku Sendai
TEL
022-717-7278
kawasaki@uro.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yoshhide |
| Middle name | |
| Last name | Kawasaki |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Urology
Zip code
9808574
Address
Seiryo-Machi 1-1 Aoba-Ku Sendai
TEL
022-717-7278
Homepage URL
kawasaki@uro.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
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
Tohoku University Graduate School of Medicine
Address
Seiryo-Machi 1-1 Aoba-Ku Sendai
Tel
022-717-7278
kawasaki@uro.med.tohoku.ac.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 25 | Day |
Related information
URL releasing protocol
As published in the paper
Publication of results
Partially published
Result
URL related to results and publications
As published in the paper "Cancer Sci . 2022 Jan;113(1):182-194. doi: 10.1111/cas.15180."
Number of participants that the trial has enrolled
20
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
| 2022 | Year | 12 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
As published in the paper
Participant flow
As published in the paper
Adverse events
No notable adverse events
Outcome measures
As published in the paper
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
| 2018 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
We have reported some of our results in a medical journal.
Accurate quantification of urinary metabolites for predictive models manifests clinicopathology of renal cell carcinoma. Sato T, et al. Cancer Sci. 2020.
We will disclose the final results as soon as possible.
Management information
Registered date
| 2017 | Year | 12 | Month | 18 | Day |
Last modified on
| 2022 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034763
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
