UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development and validation of the novel recurrence risk stratification for initial non-muscle invasive bladder cancer
Title of the study (Brief title)	Development and validation of the novel recurrence risk stratification for initial non-muscle invasive bladder cancer
Region	Japan

Condition
Condition	non-muscle invasive bladder cancer
Classification by specialty	Urology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Some risk classifications to estimate the prognosis of non muscle bladder cancer (NMIBC) patients have disadvantages in clinical use. To investigate whether the EORTC(European Organazation for Research and Treatment of Cancer) risk stratification is useful to predict recurrence and progression in Japanese patients with NMIBC. In addition, we developed and validated the novel, and simple risk classification of recurrence.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Recurrence free survival rate
Key secondary outcomes	Progression disease, and death of bladder cancer

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	23 years-old <=
Age-upper limit	99 years-old >=
Gender	Male and Female
Key inclusion criteria	In this multicentre retrospective cohort study, we analyzed data from patients with NMIBC who underwent initial TUR-Bt at 4 Juntendo University Hospitals and Teikyo University Hospital between 2000 and 2013 (JT cohort). To achieve adequate pathological staging, the complete resection aimed to include the muscle layer of the bladder wall.
Key exclusion criteria	Patients with any of the following were excluded from this analysis: (i) non-Urothelial carcinoma histology, (ii) follow-up periods < 3 months: (iii) history of muscle-invasive or metastatic bladder cancer; (iv) history of carcinoma of the urethra, prostate (ducts or stroma), or upper urinary tract; (v) history of local radiation therapy to the pelvis; (vi) history of every kind of chemotherapy; (vii) history of previous bacillus Calmette-Guerin (BCG) therapy.
Target sample size	856

Research contact person
Name of lead principal investigator	Shigeo Horie
Organization	Juntendo University, Graduate School of Medicine
Division name	Department of Urology
Address	2-1-1, Bunkyo-ku Hongo,Tokyo
TEL	03-3813-3111
Email	tieda@juntendo.ac.jp

Public contact
Name of contact person	Takeshi Ieda
Organization	Juntendo University, Graduate School of Medicine
Division name	Department of Urology
Address	2-1-1, Bunkyo-ku Hongo,Tokyo
TEL	03-3813-3111
Homepage URL
Email	tieda@juntendo.ac.jp

Sponsor
Institute	Juntendo University, Graduate School of Medicine
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	Juntendo 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)

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 04 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2000 Year 01 Month 01 Day
Anticipated trial start date	2013 Year 12 Month 31 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	There are no significant differences in RFS rates and PFS rated between groups according to EORTC risk classification. We constructed a novel risk model predicting recurrence that classified patients into 3 groups using 4 independent prognostic factors to predict tumor recurrence based on Cox proportional hazards regression analysis. There was a significant difference in 3 year RFS rate among 3 groups.

Management information
Registered date	2016 Year 04 Month 12 Day
Last modified on	2016 Year 04 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000025225