UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042278
Receipt number R000048269
Scientific Title Health-related quality of life in testicular cancer patients in Japan: A multi-institutional, longitudinal study using the Japanese version of the EORTC QLQ-TC26
Date of disclosure of the study information 2020/10/29
Last modified on 2023/05/02 12:16:33

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Basic information

Public title

QOL in testicular cancer patients using the EORTC QLQ-TC26 questionnaire

Acronym

QOL in testicular cancer patients

Scientific Title

Health-related quality of life in testicular cancer patients in Japan: A multi-institutional, longitudinal study using the Japanese version of the EORTC QLQ-TC26

Scientific Title:Acronym

Health-related quality of life in testicular cancer patients in a longitudinal study

Region

Japan


Condition

Condition

Testicular cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the health-related quality of life of testicular cancer patients using the Japanese version of the EORTC QLQ-TC26 questionnaire in a multi-institutional, longitudinal study

Basic objectives2

Others

Basic objectives -Others

QOL in testicular cancer patients

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change in QOL

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


Not applicable

Gender

Male

Key inclusion criteria

The participant is diagnosed as testicular cancer.
The participant is able to understand and respond to the questionnaires in Japanese. Informed consent is obtained from the participant.

Key exclusion criteria

The patient is assessed to be unfit by an investigator.

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Shinichi
Middle name
Last name Yamashita

Organization

Tohoku University Graduate School of Medicine

Division name

Urology

Zip code

980-8574

Address

1-1 Seiryo-machi, Aoba-ku, Sendai

TEL

022-717-7278

Email

yamashita@uro.med.tohoku.ac.jp


Public contact

Name of contact person

1st name Shinichi
Middle name
Last name Yamashita

Organization

Tohoku University Graduate School of Medicine

Division name

Urology

Zip code

980-8574

Address

1-1 Seiryo-machi, Aoba-ku, Sendai

TEL

022-717-7278

Homepage URL


Email

yamashita@uro.med.tohoku.ac.jp


Sponsor or person

Institute

Department of Urology, Tohoku University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee Tohoku University Graduate School of Medicine

Address

2-1 Seiryo-machi, Aoba-ku, Sendai

Tel

022-717-8007

Email

med-kenkyo@grp.tohoku.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

2020 Year 10 Month 29 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

No longer recruiting

Date of protocol fixation

2020 Year 10 Month 26 Day

Date of IRB

2020 Year 10 Month 26 Day

Anticipated trial start date

2021 Year 01 Month 01 Day

Last follow-up date

2023 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Survey on QOL


Management information

Registered date

2020 Year 10 Month 29 Day

Last modified on

2023 Year 05 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048269


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name