UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035673 |
|---|---|
| Receipt number | R000040635 |
| Scientific Title | Exploratory study for biomarkers in semen predicting the malignancy of prostate cancer |
| Date of disclosure of the study information | 2019/11/30 |
| Last modified on | 2022/01/26 09:39:29 |
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Basic information
Public title
Exploratory study for biomarkers in semen predicting the malignancy of prostate cancer
Acronym
Exploratory study for biomarkers in semen predicting the malignancy of prostate cancer
Scientific Title
Exploratory study for biomarkers in semen predicting the malignancy of prostate cancer
Scientific Title:Acronym
Exploratory study for biomarkers in semen predicting the malignancy of prostate cancer
Region
| Japan |
Condition
Condition
Prostate Cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In patients undergoing prostate biopsies and radical prostatectomy, exploration of the biomarkers in semen detected in highly malignant cancer
Basic objectives2
Others
Basic objectives -Others
Application to diagnostic treatment and prognosis for prostate cancer with a biomarker predicting high-grade prostate cancer
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PROS1 in semen measured by ELISA method
Key secondary outcomes
LTBP1 and 8-OHdG in semen measured by ELISA method
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
| 80 | years-old | >= |
Gender
Male
Key inclusion criteria
Patients treated with Prostate biopsy or prostate cancer patients who undergo prostatectomy
Key exclusion criteria
Patients with cancer other than in the prostate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shigeo |
| Middle name | |
| Last name | Horie |
Organization
Juntendo University, Graduate School of Medicine
Division name
Department of Urology
Zip code
113-8431
Address
3-1-3,Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5802-1227
shorie@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Shigeo |
| Middle name | |
| Last name | Horie |
Organization
Juntendo University, Graduate School of Medicine
Division name
Department of Urology
Zip code
113-8431
Address
3-1-3,Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5802-1227
Homepage URL
shorie@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
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
Juntendo University
Address
3-1-3,Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5802-1584
kenkyu5858@juntendo.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
| 2019 | Year | 11 | Month | 30 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 11 | Month | 30 | Day |
Other
Other related information
At the semen examination, we measure semen volume, sperm concentration, total sperm count, sperm motility rate, sperm normal morphology rate, sperm survival rate, white blood cell count, Spermatic malformation rate.
Management information
Registered date
| 2019 | Year | 01 | Month | 25 | Day |
Last modified on
| 2022 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040635
