UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002286 |
|---|---|
| Receipt number | R000002779 |
| Scientific Title | Clinical significance of novel serum markers for the diagnosis, staging, and the prediction of prognosis in patients with renal cell carcinoma |
| Date of disclosure of the study information | 2009/08/15 |
| Last modified on | 2020/08/14 10:04:34 |
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Basic information
Public title
Clinical significance of novel serum markers for the diagnosis, staging, and the prediction of prognosis in patients with renal cell carcinoma
Acronym
Clinical significance of novel serum markers in renal cell carcinoma
Scientific Title
Clinical significance of novel serum markers for the diagnosis, staging, and the prediction of prognosis in patients with renal cell carcinoma
Scientific Title:Acronym
Clinical significance of novel serum markers in renal cell carcinoma
Region
| Japan |
Condition
Condition
Renal cell carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
It would be economically of great benefit to find predictors for renal cell carcinoma diagnosis, staging, and prognosis more accurately. The aim of our study is to evaluate the utility of serum marker such as cytokines, MMPs and angiogenesis-related marker, for improving renal cell carcinoma diagnosis, staging, and prediction of prognosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the association between serum markers and 1)presence or absence of renal cell carcinoma, 2)cinical staging, 3)pathological staging (TNM clasification), 4) prognosis
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who will undergo the operation of renal cell carcinoma and the patients who were followed after the operation of renal cell carcinoma
Key exclusion criteria
The patients who did not agree with the purpose of this study
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Ryucihi |
| Middle name | |
| Last name | Mizuno |
Organization
Keio University School of Medicine
Division name
Department of Urology
Zip code
1608582
Address
35 Shinanomachi Shinjuku-ku, Tokyo
TEL
0333531211
moya3563@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ryuichi |
| Middle name | |
| Last name | Mizuno |
Organization
Keio University School of Medicine
Division name
Department of Urology
Zip code
1608582
Address
35Shinanomachi Shinjuku-ku
TEL
0333531211
Homepage URL
moya3563@yahoo.co.jp
Sponsor or person
Institute
Department of Urology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Keio University School of Medicine
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
Ethics Committee of KEIO
Address
35Shinanomachi Shinjuku-ku
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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
| 2009 | Year | 08 | Month | 15 | Day |
Related information
URL releasing protocol
http://www.keio-urology.jp/
Publication of results
Unpublished
Result
URL related to results and publications
http://www.keio-urology.jp/
Number of participants that the trial has enrolled
0
Results
Not started.
Results date posted
| 2020 | Year | 08 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Not started.
Participant flow
Not started.
Adverse events
Not started.
Outcome measures
Not started.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2009 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2009 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Case control sampling and prospective study
Management information
Registered date
| 2009 | Year | 08 | Month | 03 | Day |
Last modified on
| 2020 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002779
| Research Plan | |
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| 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 |
