UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039542 |
|---|---|
| Receipt number | R000045073 |
| Scientific Title | Retrospective study of prostate biopsy in patients with suspicion of prostate cancer |
| Date of disclosure of the study information | 2020/02/20 |
| Last modified on | 2020/08/21 14:07:15 |
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Basic information
Public title
Retrospective study of prostate biopsy in patients with suspicion of prostate cancer
Acronym
Retrospective study of prostate biopsy on suspicion of prostate cancer
Scientific Title
Retrospective study of prostate biopsy in patients with suspicion of prostate cancer
Scientific Title:Acronym
Retrospective study of prostate biopsy on suspicion of prostate cancer
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate clinical factors and positive rate of prostate cancer in patients with high level of PSA
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
positive rate of prostate biopsy and associated clinical factors
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
| 85 | years-old | >= |
Gender
Male
Key inclusion criteria
patients who are not diagnosed as prostate cancer previously
patients undergone prostate biopsies between Jan/1st/2016 and Dec/31/2016, between PSA levels 5 to 19.9 ng/mL
Key exclusion criteria
patients who had been diagnosed as prostate cancer
patients with PSA level, PSA<5, >=20 ng/mL
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hiroji |
| Middle name | |
| Last name | Uemura |
Organization
Yokohama City University Medical Center
Division name
Department of Urology & Renal Transplantation
Zip code
232-0024
Address
4-57, Urafune-cho, Minami-ku, Yokohama, 232-0024
TEL
045-261-5656
hu0428@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroji |
| Middle name | |
| Last name | Uemura |
Organization
Yokohama City University Medical Center
Division name
Department of Urology & Renal Transplantation
Zip code
232-0024
Address
4-57, Urafune-cho, Minami-ku, Yokohama, 232-0024
TEL
045-261-5656
Homepage URL
hu0428@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Yokohama City University Medical Center
Address
4-57, Urafune-cho, Minami-ku, Yokohama, 232-0024
Tel
045-261-5656
hu0428@yokohama-cu.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 | 02 | Month | 20 | 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
1000
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
| 2019 | Year | 05 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 19 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Using the data of 977 cases from 6 institutes, retrospective analysis was performed. We investigated the rates of biopsy positive and negative, with or without anti-hypertension (includign ARBs or non-ARBs), PSA trends during follow-up after biopsy (negative case), and the results of repeated biopsy. Retrospective investigation in the cohort with PSA 20 or more has been added.
Management information
Registered date
| 2020 | Year | 02 | Month | 20 | Day |
Last modified on
| 2020 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045073
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2021/03/01 | 200308前立腺癌 後ろ向き試験（20210301）.xlsx |
