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
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
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
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
