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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002251
Receipt No. R000002756
Scientific Title preliminary study of the efficacy of 5ALA on prostate cancer
Date of disclosure of the study information 2009/08/01
Last modified on 2017/08/04

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Basic information
Public title preliminary study of the efficacy of 5ALA on prostate cancer
Acronym preliminary study of the efficacy of 5ALA on prostate cancer
Scientific Title preliminary study of the efficacy of 5ALA on prostate cancer
Scientific Title:Acronym preliminary study of the efficacy of 5ALA on prostate cancer
Region
Japan

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

Objectives
Narrative objectives1 The patient,who will be performed radical prostatectomy,intake 5ALA before the operation,we observe prostate cancer,which produce fluorescence or not,through the fluorescent endoscopy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the existence or nonexistence of fluorescence in tumor
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 5ALA oral intake
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

Not applicable
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria none
Key exclusion criteria photo-sensitive patients
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Isao KURODA
Organization Saitama Medical University,International Medical Center
Division name Uro-oncology
Zip code
Address 1397-1,Yamane,Hidaka,Saitama,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Isao KURODA
Organization Saitama Medical University,International Medical Center
Division name Uro-oncology
Zip code
Address 1397-1,Yamane,Hidaka,Saitama,Japan
TEL
Homepage URL
Email

Sponsor
Institute Saitama Medical University,International Medical Center
Department of Uro-oncology
Institute
Department

Funding Source
Organization Saitama Medical University,International Medical Center
Department of Uro-oncology
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
Address
Tel
Email

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
2009 Year 08 Month 01 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
2009 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 07 Month 26 Day
Last modified on
2017 Year 08 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002756

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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