UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024642 |
|---|---|
| Receipt number | R000016378 |
| Scientific Title | Clinical evaluation of 5-ALA/SFC for cisplatin induced renal injury |
| Date of disclosure of the study information | 2016/10/31 |
| Last modified on | 2021/05/06 10:34:21 |
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Basic information
Public title
Clinical evaluation of 5-ALA/SFC for cisplatin induced renal injury
Acronym
ALA/SFC-Study
Scientific Title
Clinical evaluation of 5-ALA/SFC for cisplatin induced renal injury
Scientific Title:Acronym
ALA/SFC-Study
Region
| Japan |
Condition
Condition
Unresectable gastric cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Clinical applying 5-aminolevulinic acid(5-ALA) as new renal failure prophylaxis for the cisplatin induced renal injury
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety of 5-ALA/SFC as the prevention of renal failure supplement
Key secondary outcomes
Renal failure depression effect
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food |
Interventions/Control_1
5-aminolevulinic acid
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Unresectable gastric cancer case
Key exclusion criteria
Contraindication cases of S-1 or cisplatin administration
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tomoki |
| Middle name | |
| Last name | Yamatuji |
Organization
kawasaki medical school
Division name
general surgery
Zip code
700-8505
Address
2-6-1 nakasange kitaku okayama city japan
TEL
0862252111
kosaka.r@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Tomoki |
| Middle name | |
| Last name | Yamatuji |
Organization
kawasaki medical school
Division name
general surgery
Zip code
700-8505
Address
2-6-1 nakasange kitaku okayama city japan
TEL
0862252111
Homepage URL
https://g.kawasaki-m.ac.jp/dept/geka/ekigaku
kosaka.r@med.kawasaki-m.ac.jp
Sponsor or person
Institute
kawasaki medical school
Institute
Department
Personal name
Funding Source
Organization
kawasaki medical school
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School . Hospital Ethics Committee
Address
577 Matsushima, Kurashiki City, Okayama Prefecture
Tel
0864641076
kmsrec@med.kawasaki-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 | 10 | Month | 31 | 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
12
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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | 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 | 10 | Month | 31 | Day |
Last modified on
| 2021 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016378
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
