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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022636
Receipt No. R000026097
Scientific Title Clinical trials about the correlation of change and PSA of the MRI (DWI-ADC) after a treatment halfway point and the end of treatment radiotherapy for prostate cancer
Date of disclosure of the study information 2016/06/07
Last modified on 2019/06/29

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Basic information
Public title Clinical trials about the correlation of change and PSA of the MRI (DWI-ADC) after a treatment halfway point and the end of treatment radiotherapy for prostate cancer
Acronym Correlation of change and PSA of the MRI after a treatment halfway point and the end of treatment radiotherapy for prostate cancer
Scientific Title Clinical trials about the correlation of change and PSA of the MRI (DWI-ADC) after a treatment halfway point and the end of treatment radiotherapy for prostate cancer
Scientific Title:Acronym Correlation of change and PSA of the MRI after a treatment halfway point and the end of treatment radiotherapy for prostate cancer
Region
Japan

Condition
Condition prostate cancer
Classification by specialty
Urology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Correlative of examines MRI-ADC and the value with the PSA test in radiotherapy for prostate cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes A correlation is seen in MRI image findings and a value of the blood test PSA
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
50 years-old <=
Age-upper limit
90 years-old >
Gender Male
Key inclusion criteria Performance status is the patient of 0 or 1. The patients that a written consent was obtained.
Key exclusion criteria Patient with no informed consent.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name tanaka
Middle name
Last name Osamu
Organization Gifu Municipal Hospital
Division name Department of Radiation Oncology
Zip code 5008523
Address 7-1 kashima-cho Gifu Japan
TEL 058-251-1101
Email c.bluered@gmail.com

Public contact
Name of contact person
1st name OSAMU
Middle name
Last name TANAKA
Organization Gifu Municipal Hospital
Division name Department of Radiation Oncology
Zip code 5008523
Address Gifu
TEL +819076730893
Homepage URL
Email c.bluered@gmail.com

Sponsor
Institute Gifu Municipal Hospital
Institute
Department

Funding Source
Organization self
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Asahi University
Address 3-23 Hashimoto-cho
Tel +819076730893
Email c.bluered@gmail.com

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
2016 Year 06 Month 07 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 Completed
Date of protocol fixation
2016 Year 05 Month 17 Day
Date of IRB
2016 Year 05 Month 10 Day
Anticipated trial start date
2016 Year 06 Month 07 Day
Last follow-up date
2017 Year 03 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We observe a state of prostate cancer of the patients and a correlation with the blood test PSA using noninvasive MR imaging

Management information
Registered date
2016 Year 06 Month 07 Day
Last modified on
2019 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026097

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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