UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043489 |
|---|---|
| Receipt number | R000049660 |
| Scientific Title | study of PROstate cancer, gut MicrobIome, and lifeStylE in JAPAN (PROMISE-JAPAN) |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2021/03/05 09:16:43 |
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Basic information
Public title
study of PROstate cancer, gut MicrobIome, and lifeStylE in JAPAN (PROMISE-JAPAN)
Acronym
study of PROstate cancer, gut MicrobIome, and lifeStylE in JAPAN (PROMISE-JAPAN)
Scientific Title
study of PROstate cancer, gut MicrobIome, and lifeStylE in JAPAN (PROMISE-JAPAN)
Scientific Title:Acronym
study of PROstate cancer, gut MicrobIome, and lifeStylE in JAPAN (PROMISE-JAPAN)
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Assess the association of microbiome, prostate cancer and genetic background
Basic objectives2
Others
Basic objectives -Others
Assess the association with lifestyle
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identify Microbiome associated with prostate cancer
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
Patients with prostate cancer or suspicious prostate cancer who is above 20 years old
Key exclusion criteria
receiving Antibiotics
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Uemura |
| Middle name | |
| Last name | Hirotsugu |
Organization
Kindai University Faculty of Medicine
Division name
Department of Urology
Zip code
589-8511
Address
377-2 Oono-higashi, Osakasayama,
TEL
072-366-0221
huemura@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Fujita |
| Middle name | |
| Last name | Kazutoshi |
Organization
Kindai University Faculty of Medicine
Division name
Department of Urology
Zip code
589-8511
Address
377-2 Oono-higashi, Osakasayama,
TEL
072-366-0221
Homepage URL
kfujita@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Kindai Hospital IRB
Address
377-2 Oono-higashi, Osakasayama
Tel
072-366-0221
zizen@med.kindai.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
| 2021 | 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
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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 03 | Month | 02 | Day |
Last modified on
| 2021 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049660
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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