UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Recruitment status Terminated
Unique ID issued by UMIN UMIN000011569
Receipt No. R000013532
Official scientific title of the study Levels of urinary OAB biomarker and voiding symptom score in bladder cancer patients recieving intravesical BCG therapy
Date of disclosure of the study information 2013/09/01
Last modified on 2018/02/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study Levels of urinary OAB biomarker and voiding symptom score in bladder cancer patients recieving intravesical BCG therapy
Title of the study (Brief title) Urinary biomarker study of BCG-induced OAB
Region
Japan

Condition
Condition overactive bladder
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify the urinary OAB biomarkers which correlates with voiding symptom scores in patients recieving intravesical BCG therapy
Basic objectives2 Others
Basic objectives -Others biomarker study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Validated questionnaire such as OABSS, IPSS and CLSS.
Urinary NGF and BDNF levels.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria High-risk nonmuscle-invasive bladder cancer patients receiving intravesical BCG therapy after TURBT
Key exclusion criteria Residual urine >100ml
Urinary infection
Gross hematuria
Target sample size 40

Research contact person
Name of lead principal investigator Eiji Kikuchi
Organization Keio University School of Medicine
Division name Department of Urology
Address 35 Shinanomachi, Shinjyuku, Tokyo
TEL 03-3353-1211
Email eiji-k@kb3.so-net.ne.jp

Public contact
Name of contact person Katsura Ishioka
Organization Keio University School of Medicine
Division name Department of Urology
Address 35 Shinanomachi, Shinjyuku, Tokyo
TEL 03-3353-1211
Homepage URL
Email katsuran-h@a5.keio.jp

Sponsor
Institute Keio University School of Medicine,
Department of Urology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Keio University School of Medicine,
Department of Urology
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

Other administrative information
Date of disclosure of the study information
2013 Year 09 Month 01 Day

Progress
Recruitment status Terminated
Date of protocol fixation
2013 Year 08 Month 01 Day
Anticipated trial start date
2013 Year 08 Month 23 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 terminated

Management information
Registered date
2013 Year 08 Month 23 Day
Last modified on
2018 Year 02 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013532


Contact us.