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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025498
Receipt No. R000029342
Scientific Title PD-L1 expression of bladder cancer specimens
Date of disclosure of the study information 2020/04/01
Last modified on 2017/01/03

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Basic information
Public title PD-L1 expression of bladder cancer specimens
Acronym PD-L1 expression of bladder cancer specimens
Scientific Title PD-L1 expression of bladder cancer specimens
Scientific Title:Acronym PD-L1 expression of bladder cancer specimens
Region
Japan

Condition
Condition bladder cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Programmed cell death ligand 1 expression of bladder cancer specimens
Basic objectives2 Others
Basic objectives -Others Relationship between PD-L1 expression and prognosis in bladder cancer patients
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes cause-specific survival
disease-free survival
Key secondary outcomes

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
20 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria bladder cancer patients treated with total cystectomy
Key exclusion criteria Patients that we can not investigate prognostic survey
Target sample size 102

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Hashimoto
Organization Hirosaki University
Division name Department of Urology
Zip code
Address 5 Zaifucho, Hirosaki, Aomori, Japan
TEL 0172-39-5091
Email bikkuri@opal.plala.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuhiro Hashimoto
Organization Hirosaki University
Division name Department of Urology
Zip code
Address 5 Zaifucho, Hirosaki, Aomori, Japan
TEL 0172-39-5091
Homepage URL
Email bikkuri@opal.plala.or.jp

Sponsor
Institute Hirosaki University
Institute
Department

Funding Source
Organization Hirosaki University
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2020 Year 04 Month 01 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 Of the 102 patients, 82 were men (81.0%) and 20 were women (19.0%) (mean age, 60 years, range, 43-84 years). Sixty-six patients (64.8%) had previously undergone neoadjuvant chemotherapy [neoadjuvant (+) group]. During the mean observation period of 54.5 months, 42 patients had recurring disease (41.1%) and 34 died (33.3%). The five-year cause-specific survival rate (CSS) was 66.6%; the five-year disease-free survival rate (DFS) was 59.7%.
In the neoadjuvant (+) group, the 5-year DFS rate was 65.0% for PD-L1 (-) patients and 31.7% for PD-L1 (+) patients (log-rank p = 0.006). In the neoadjuvant (+) groups, the 5-year CSS rate was 69.6% for PD-L1 (-) patients and 48.1% for PD-L1 (+) patients. Differences in CSS and DFS rates between PD-L1 (-) and PD-L1 (+) patients in both treatment groups were statistically significant (log-rank p = 0.006 and 0.039, respectively.)
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
2015 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We enrolled 102 bladder cancer patients treated with cystectomy at the Aomori Prefectural Hospital between April 2004 and May 2014.
We conducted an immunohistochemical examination of PD-L1 expression using the SP142 assay. PD-L1 expression was scored at three diagnostic levels (0/1/2).

Management information
Registered date
2017 Year 01 Month 02 Day
Last modified on
2017 Year 01 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029342

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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