UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the accuracy of prostate cancer diagnosis with carbohydrate biomarker test
Acronym	Evaluation of the accuracy of prostate cancer diagnosis with carbohydrate biomarker test
Scientific Title	Evaluation of the accuracy of prostate cancer diagnosis with carbohydrate biomarker test
Scientific Title:Acronym	Evaluation of the accuracy of prostate cancer diagnosis with carbohydrate biomarker test
Region	Japan

Condition
Condition	Suspected prostate cancer
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the usefulness in the detection of prostate cancer with serum PSA level and magnetic resonance imaging.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationship between PSA Gi, serum PSA level, MRI finding, and pathological findings of the prostate biopsy
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	Not applicable
Gender	Male
Key inclusion criteria	1. Prostate cancer suspected person whose serum PSA level with and larger than 0.1ng/mL. 2. Prostate cancer suspected person who are able to be receive MRI-TRUS fusion image-guided biopsy. 3. Prostate cancer suspected person who agree with informed consent.
Key exclusion criteria	1. Person who are considered as worsen their health condition due to blood test. 2. Person who are regarded as inappropriate for the study by the researcher.
Target sample size	204

Research contact person
Name of lead principal investigator	1st name Sunao Middle name Last name Shoji
Organization	Tokai University
Division name	School of Medicine
Zip code	259-1193
Address	143 Shimokasuya, Isehara, Kanagawa
TEL	0463-93-1121
Email	sunashoj@mail.goo.ne.jp

Public contact
Name of contact person	1st name Sunao Middle name Last name Shoji
Organization	Tokai University
Division name	School of Medicine
Zip code	259-1193
Address	143 Shimokasuya, Isehara, Kanagawa
TEL	0463-93-1121
Homepage URL
Email	sunashoj@mail.goo.ne.jp

Sponsor
Institute	Tokai University
Institute
Department

Funding Source
Organization	Tokai 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	Institutional Review Board for Clinical Research, Tokai University
Address	143 Shimokasuya, Isehara, Kanagawa
Tel	0463-93-1121
Email	tokai-rinsho@ml.tokai-u.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 07 Month 25 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	No longer recruiting
Date of protocol fixation	2018 Year 10 Month 10 Day
Date of IRB	2018 Year 10 Month 20 Day
Anticipated trial start date	2018 Year 10 Month 10 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2020 Year 07 Month 25 Day
Last modified on	2022 Year 04 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047056