UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035673
Receipt No. 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 2019/12/02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email shorie@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

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
Email 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 Open public recruiting
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 01 Month 19 Day
Last follow-up date
2022 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2019 Year 12 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040635

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.