UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038748
Receipt number R000044175
Scientific Title Effect of immunotherapy on oncological and patientst reported outcomes in patients with metastatic renal cell cancer
Date of disclosure of the study information 2019/12/01
Last modified on 2023/03/21 10:19:25

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Basic information

Public title

Effect of immunotherapy on oncological and patientst reported outcomes in patients with metastatic renal cell cancer

Acronym

Effect of immunotherapy on oncological and patientst reported outcomes in patients with metastatic renal cell cancer

Scientific Title

Effect of immunotherapy on oncological and patientst reported outcomes in patients with metastatic renal cell cancer

Scientific Title:Acronym

Effect of immunotherapy on oncological and patientst reported outcomes in patients with metastatic renal cell cancer

Region

Japan


Condition

Condition

Renal cell cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Investigate effects of immunotherapy on oncological and patient reported outcomes inpatients with metastatic renal cell cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Effects of immunotherapy on oncological outcomes inpatients with renal cell cancer

Key secondary outcomes

Effects of immunotherapy on patient reported outcomes inpatients with renal cell cancer


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Treatment group: Patients received immunotherapy for metastatic renal cell cancer

Interventions/Control_2

Control group: Standard tyrosine kinase inhibitors for metastatic renal cell cancer

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

100 years-old >

Gender

Male and Female

Key inclusion criteria

Urothelial cancer who need systemic therapy or immunotherapy

Key exclusion criteria

History of severe cardiac conditions, such as angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study.
History of significant central nervous system (CNS) injuries (including stroke or spinal cord injury) within 6 months of Visit 1. History of drug, alcohol, or substance abuse within the 6 months before Visit 1.
Have any condition, limitation, or disease that could, in the judgment of the investigator, preclude evaluation of response to therapy and QoL

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Shingo
Middle name
Last name Hatakeyama

Organization

Hirosaki Univ.

Division name

Urology

Zip code

036-8562

Address

5 Zaifu-chou, Hirosaki, Japan

TEL

+81172395091

Email

shingoh@hirosaki-u.ac.jp


Public contact

Name of contact person

1st name Shingo
Middle name Hatakeyama
Last name Hatakeyama

Organization

Dept. of Urology, Hirosaki University Graduate School of Medicine

Division name

Urology

Zip code

036-8562

Address

Hirosaki

TEL

+81172395091

Homepage URL


Email

shingoh@hirosaki-u.ac.jp


Sponsor or person

Institute

Dept. of Urology, Hirosaki University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Dept. of Urology, Hirosaki 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

Hirosaki University Graduate School of Medicine

Address

5 Zaifu-chou, Hirosaki, Japan

Tel

0172-33-5111

Email

rinri@hirosaki-u.ac.jp


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

2019 Year 12 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

23

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

Terminated

Date of protocol fixation

2019 Year 11 Month 30 Day

Date of IRB

2018 Year 08 Month 24 Day

Anticipated trial start date

2019 Year 12 Month 01 Day

Last follow-up date

2022 Year 12 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 11 Month 30 Day

Last modified on

2023 Year 03 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044175


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name