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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010865
Receipt No. R000012713
Scientific Title Development of diagnostic method using a fluorescent labeled glucose in urological cancer
Date of disclosure of the study information 2013/08/01
Last modified on 2016/06/04

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Basic information
Public title Development of diagnostic method using a fluorescent labeled glucose in urological cancer
Acronym Development of diagnostic method using a fluorescent labeled glucose in urological cancer
Scientific Title Development of diagnostic method using a fluorescent labeled glucose in urological cancer
Scientific Title:Acronym Development of diagnostic method using a fluorescent labeled glucose in urological cancer
Region
Japan

Condition
Condition Urinary Bladder Cancer, Prostate Cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The present invention aims to visualize the lesions of cancer for diagnosis using the fluorescently labeled glucose.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Confirmation of fluorescence labeled glucose taken in only cancer cells in urinary bladder cancer and prostate cancer.
Key secondary outcomes Correlation between fluorescence degree and malignant potential of urinary bladder cancer and prostate cancer.

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
Device,equipment
Interventions/Control_1 fluorescently labeled glucose test
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
18 years-old <=
Age-upper limit
95 years-old >=
Gender Male
Key inclusion criteria Patients with urinary bladder cancer who will receive endoscopic resection of bladder tumor, or patients who are suspicious for prostate cancer (PSA level >= 4).
Key exclusion criteria Patients who did not obtain written informed consent.
Target sample size 100

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Shingo Hatakeyama
Organization Hirosaki University Hospital
Division name Urology
Zip code
Address 53, Honchou, Hirossaki
TEL 0172-39-5091
Email shingorilla2@gmail.com

Public contact
1st name of contact person
1st name
Middle name
Last name Shingo Hatakeyama
Organization Hirosaki University Hospital
Division name Urology
Zip code
Address 53, Honchou, Hirossaki
TEL +81172395091
Homepage URL
Email shingorilla2@gmail.com

Sponsor
Institute Hirosaki University School of Medicine
Institute
Department

Funding Source
Organization Hirosaki University
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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
2013 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 Enrolling by invitation
Date of protocol fixation
2013 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 06 Month 04 Day
Last modified on
2016 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012713

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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