UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020039
Receipt number R000023141
Scientific Title Clinical features, prognostic factors and outcomes of urothelial cancer: Retrospective study
Date of disclosure of the study information 2016/01/01
Last modified on 2018/06/04 14:14:38

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Basic information

Public title

Clinical features, prognostic factors and outcomes of urothelial cancer: Retrospective study

Acronym

Retrospective registration study on urothelial cancer

Scientific Title

Clinical features, prognostic factors and outcomes of urothelial cancer: Retrospective study

Scientific Title:Acronym

Retrospective registration study on urothelial cancer

Region

Japan


Condition

Condition

urothelial cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Investigating an impact of clinicopathological features on oncological outcomes of urothelial cancers in Gunma University Hospital.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Outcomes in terms of complete resection, recurrence, progression to invasive cancer or metastatic cancer, cause-specific survival and overall survival

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

Patients diagnosed with urothelial cancer in Gunma University Hospital between January 1st, 2005 and December 31, 2020

Key exclusion criteria

1) Men who refuse to participate in the study
2) Men whom researchers judge to inappropriate to participate in the study

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhiro Suzuki

Organization

Gunma University Hospital

Division name

Urology

Zip code


Address

3-39-22, Showa-machi, Maebashi, Gunma, Japan

TEL

027-220-8303

Email

kazu@gunma-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Atusuko Ohyama

Organization

Gunma University Graduate School of Medicine

Division name

Urology

Zip code


Address

3-39-22, Showa-machi, Maebashi, Gunma, Japan

TEL

027-220-8303

Homepage URL


Email

a-ohyama@gunma-u.ac.jp


Sponsor or person

Institute

Department of Urology, Gunma University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Urology, Gunma University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Other

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



Other administrative information

Date of disclosure of the study information

2016 Year 01 Month 01 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

Preinitiation

Date of protocol fixation

2015 Year 12 Month 22 Day

Date of IRB


Anticipated trial start date

2016 Year 01 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

The purpose of the present retrospective study is investigating an impact of clinicopathological features on oncological outcomes of urothelial cancers in Gunma University Hospital
Declare outcomes and complications of urothelial cancer in Gunma University Hospital and exploring prognostic factors of urothelial cancer may contribute progress in medicine in this field.


Management information

Registered date

2015 Year 12 Month 02 Day

Last modified on

2018 Year 06 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023141


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name