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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021878
Receipt No. R000025225
Scientific Title Development and validation of the novel recurrence risk stratification for initial non-muscle invasive bladder cancer
Date of disclosure of the study information 2016/04/12
Last modified on 2016/04/12

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Basic information
Public title Development and validation of the novel recurrence risk stratification for initial non-muscle invasive bladder cancer
Acronym Development and validation of the novel recurrence risk stratification for initial non-muscle invasive bladder cancer
Scientific Title Development and validation of the novel recurrence risk stratification for initial non-muscle invasive bladder cancer
Scientific Title:Acronym 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

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

Public contact
1st name of contact person
1st name
Middle name
Last name Takeshi Ieda
Organization Juntendo University, Graduate School of Medicine
Division name Department of Urology
Zip code
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

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)

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 04 Month 12 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 Completed
Date of protocol fixation
2000 Year 01 Month 01 Day
Date of IRB
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

Other
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-open-bin/ctr_e/ctr_view.cgi?recptno=R000025225

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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