UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021878 |
|---|---|
| Receipt number | 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 00:24:59 |
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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
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
tieda@juntendo.ac.jp
Public contact
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
tieda@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University, Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025225
