UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031565 |
|---|---|
| Receipt number | R000036040 |
| Scientific Title | Analysis of personality, treatment choice and QOL in patients with localized prostate cancer in Japan |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2023/03/19 13:57:02 |
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Basic information
Public title
Analysis of personality, treatment choice and QOL in patients with localized prostate cancer in Japan
Acronym
Analysis of personality and QOL in patients with localized prostate cancer
Scientific Title
Analysis of personality, treatment choice and QOL in patients with localized prostate cancer in Japan
Scientific Title:Acronym
Analysis of personality and QOL in patients with localized prostate cancer
Region
| Japan |
Condition
Condition
Localized prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the association personality questionnaire with treatment decision making for localized prostate cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Personality analysis
Key secondary outcomes
Longitudinal QOL assessment
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
| 45 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male
Key inclusion criteria
mpMRI <T3
PSA<20 ng/ml
No distant metastsis
Key exclusion criteria
None
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Sasaki |
Organization
Jikei University School of Medicine
Division name
Urology
Zip code
1058461
Address
3-25-8, Nishishinbashi, Minato-ku, Tokyo
TEL
03-3433-1111
hs06@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Sasaki |
Organization
Jikei University School of Medicine
Division name
Urology
Zip code
1058461
Address
3-25-8, Nishishinbashi, Minato-ku, Tokyo
TEL
03-3433-1111
Homepage URL
hs06@jikei.ac.jp
Sponsor or person
Institute
Jikei University School of Medicne
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
Jikei University IRB
Address
3-25-8, Nishi-shinbashi, Minatoku, Tokyo
Tel
03-3433-1111
rinri@jikei.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
慈恵医大附属病院
Other administrative information
Date of disclosure of the study information
| 2018 | 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
200
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
| 2017 | Year | 03 | Month | 12 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 06 | Month | 30 | Day |
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 03 | Month | 04 | Day |
Last modified on
| 2023 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036040
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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