UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017549
Receipt number R000020344
Scientific Title Staging in urothelial carcinoma by using optical coherence tomography
Date of disclosure of the study information 2015/05/13
Last modified on 2015/05/13 21:35:09

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Basic information

Public title

Staging in urothelial carcinoma by using optical coherence tomography

Acronym

Staging by OCT in Urothelial carcinoma

Scientific Title

Staging in urothelial carcinoma by using optical coherence tomography

Scientific Title:Acronym

Staging by OCT in Urothelial carcinoma

Region

Japan


Condition

Condition

Urothelial carcinoma

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Development of staging method for urothelical carcinoma by OCT.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Safety

Key secondary outcomes



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

Diagnosis

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

OCT

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

20 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

Patinets with urothelial carcinoma.

Key exclusion criteria

Difficult in performing ureteroscopy.

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Haruki, KUME

Organization

The University of Tokyo

Division name

Urology

Zip code


Address

Bunkyo-ku, Hongo, 7-3-1

TEL

+81-3-5800-8753

Email

ezy04707@nifty.com


Public contact

Name of contact person

1st name
Middle name
Last name Haruki, KUME

Organization

The University of Tokyo

Division name

Urology

Zip code


Address

Bunkyo-ku, Hongo, 7-3-1

TEL

+81-3-5800-8753

Homepage URL


Email

ezy04707@nifty.com


Sponsor or person

Institute

Dept. of Urology, The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

Dept. of Urology, The University of Tokyo

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

2015 Year 05 Month 13 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 02 Month 26 Day

Date of IRB


Anticipated trial start date

2015 Year 05 Month 15 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 05 Month 13 Day

Last modified on

2015 Year 05 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020344


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name