UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The usefulness of extended lymphadenectomy and molecular staging for urothelial carcinoma patients who undergo nephroureterectomy or total cystectomy
Title of the study (Brief title)	The usefulness of extended lymphadenectomy and molecular staging for urothelial carcinoma patients who undergo nephroureterectomy or total cystectomy
Region	Japan

Condition
Condition	Urothelial carcinoma patients who undergo nephroureterectomy or total cystectomy
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We examine whether extended lymphadenectomy for urothelical carcinoma can improve survival or not. We also investigate the usefulness of molecular staging using RT-PCR for removed lymph nodes.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	Disease specific survival Prognostic factor of molecular staging using RT-PCR method

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Extended lymphadenectomy
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	Urothelial carcinoma patients who undergo nephroureterectomy or total cystectomy , had written informed consent
Key exclusion criteria	No informed consent
Target sample size	100

Research contact person
Name of lead principal investigator	Isao Hara
Organization	Wakayama Medical University
Division name	Urology
Address	811-1 KImiidera, Wakayama, Japan
TEL	073-441-0637
Email	hara@wakayama-med.ac.jp

Public contact
Name of contact person	Isco Hara, M.D.
Organization	Wakayama Medical University
Division name	Urology
Address	811-1 KImiidera, Wakayama, Japan
TEL	073-441-0637
Homepage URL
Email	hara@wakayama-med.ac.jp

Sponsor
Institute	Department of Urology, Wakayama Medical University
Institute
Department

Funding Source
Organization	Department of Urology, Wakayama Medical University
Organization
Division
Category of Funding Organization	Local Government
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	和歌山県立医科大学（和歌山県） 東京女子医科大学（東京都） 市立岸和田市民病院（大阪府） 市立泉佐野病院（大阪府） 国立病院機構大阪南医療センター（和歌山県） 和歌山労災病院（和歌山県） 社会保険紀南病院（和歌山県）

Other administrative information
Date of disclosure of the study information	2009 Year 09 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 09 Month 15 Day
Anticipated trial start date	2009 Year 10 Month 01 Day
Last follow-up date	2014 Year 08 Month 01 Day
Date of closure to data entry	2017 Year 07 Month 01 Day
Date trial data considered complete	2017 Year 09 Month 01 Day
Date analysis concluded	2017 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2009 Year 09 Month 17 Day
Last modified on	2018 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000003080