UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025498
Receipt number 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 10:17:56

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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 or person

Institute

Hirosaki University

Institute

Department

Personal name



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

Value
https://center6.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