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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030398
Receipt No. R000034705
Scientific Title The prediction of post-operative metastasis using for the ISYNA1 expression analysis in primary renal cancer.
Date of disclosure of the study information 2017/12/21
Last modified on 2017/12/14

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Basic information
Public title The prediction of post-operative metastasis using for the ISYNA1 expression analysis in primary renal cancer.
Acronym The prediction of post-operative metastasis using for the ISYNA1 expression analysis in primary renal cancer.
Scientific Title The prediction of post-operative metastasis using for the ISYNA1 expression analysis in primary renal cancer.
Scientific Title:Acronym The prediction of post-operative metastasis using for the ISYNA1 expression analysis in primary renal cancer.
Region
Japan

Condition
Condition Renal cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine whether the ISYNA1 expression in primary renal cancer of surgery patients can predict the appearance of post-operative metastasis.
Basic objectives2 Others
Basic objectives -Others The period until appearance of post-operative metastasis.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The period until appearance of post-operative metastasis.
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 Study participants were selected from the patient who was operated for renal cancer at the Fukushima Medical University Hospital from November, 2012
Key exclusion criteria Patient with preoperative metastasis
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiyuki Kojima
Organization Fukushima Medical University School of Medicine
Division name Department of Urology
Zip code
Address 1 Hikarigaoka, Fukushima-shi, Fukushima, Japan
TEL 024-543-1316
Email ykojima@fmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoyuki Koguchi
Organization Fukushima Medical University School of Medicine
Division name Department of Urology
Zip code
Address 1 Hikarigaoka, Fukushima-shi, Fukushima, Japan
TEL 024-543-1316
Homepage URL
Email gucchii@fmu.ac.jp

Sponsor
Institute Department of Urology, Fukushima Medical University School of Medicine
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
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 福島県立医科大学病院(福島県)、太田西ノ内病院(福島県)、竹田綜合病院(福島県)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 21 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
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 Open public recruiting
Date of protocol fixation
2012 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To examine whether the ISYNA1 expression in primary renal cancer of surgery patients can predict the appearance of post-operative metastasis.

Management information
Registered date
2017 Year 12 Month 14 Day
Last modified on
2017 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034705

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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