UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021068 |
|---|---|
| Receipt number | R000024165 |
| Scientific Title | New Diagnostic Method of Lymph Nodes metastases and Surgical Margins Using 5-Aminolevulinic Acid in Urothelial Carcinoma and Prostate Cancer. |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2023/03/03 13:53:08 |
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Basic information
Public title
New Diagnostic Method of Lymph Nodes metastases and Surgical Margins Using 5-Aminolevulinic Acid in Urothelial Carcinoma and Prostate Cancer.
Acronym
Diagnosis of lymph nodes metastases of urological malignancy using 5-ALA
Scientific Title
New Diagnostic Method of Lymph Nodes metastases and Surgical Margins Using 5-Aminolevulinic Acid in Urothelial Carcinoma and Prostate Cancer.
Scientific Title:Acronym
Diagnosis of lymph nodes metastases of urological malignancy using 5-ALA
Region
| Japan |
Condition
Condition
Urothelial cancer, Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of new diagnosis system using 5-ALA for urothelial carcinoma and prostate cancer as pathological diagnosis during surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy
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 | Device,equipment |
Interventions/Control_1
Single oral dose of 5-ALA before surgery
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 and Female
Key inclusion criteria
Prostate or urothelial cancer who undergo prostatectomy, cystectomy or nephroureterectomy
PS 0-1
given written informed consent
Key exclusion criteria
Porphyria
Hypersensitivity of 5-ALA
pregnant or possibly pregnant women
severe cardiac, pulmonary, renal, hepatic, or hematopoietic impairment or uncontrolled diabetes mellitus
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Ukimura |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Urology
Zip code
6028566
Address
465 kajiicho, Kamigyoku, Kyoto
TEL
075-251-5595
ukimura@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Yoshio |
| Middle name | |
| Last name | Naya |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Urology
Zip code
6028566
Address
465kajiicho, Kamigyoku, Kyoto
TEL
075-251-5595
Homepage URL
ynaya@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
USHIO INC.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine, Clinical Reserach Review Board
Address
465 kajii-cho, Kawaramachi-Hirokoji, kamigyo-ku, Kyoto, japan
Tel
075-251-5337
rinri@koto.kpu-m.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
| 2016 | Year | 06 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 17 | Day |
Last modified on
| 2023 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024165
