UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The prediction of post-operative metastasis using for the ISYNA1 expression analysis in primary renal cancer.
Title of the study (Brief title)	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	Yoshiyuki Kojima
Organization	Fukushima Medical University School of Medicine
Division name	Department of Urology
Address	1 Hikarigaoka, Fukushima-shi, Fukushima, Japan
TEL	024-543-1316
Email	ykojima@fmu.ac.jp

Public contact
Name of contact person	Tomoyuki Koguchi
Organization	Fukushima Medical University School of Medicine
Division name	Department of Urology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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