UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010865 |
|---|---|
| Receipt number | 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 | 2021/06/02 09:29:57 |
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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
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Hatakeyama |
Organization
Hirosaki University Hospital
Division name
Urology
Zip code
036-8562
Address
53, Honchou, Hirossaki
TEL
0172-39-5091
shingorilla2@gmail.com
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Hatakeyama |
Organization
Hirosaki University Hospital
Division name
Urology
Zip code
036-8562
Address
53, Honchou, Hirossaki
TEL
+81172395091
Homepage URL
shingorilla2@gmail.com
Sponsor or person
Institute
Hirosaki University School of Medicine
Institute
Department
Personal name
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
Hirosaki Universicy IRB
Address
5 zaifu, hrosaki
Tel
0172-39-5043
rinri@hirosaki-u.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
| 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
| 2021 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012713
