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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024642
Receipt No. 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 2019/05/08

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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
Email 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
Email kosaka.r@med.kawasaki-m.ac.jp

Sponsor
Institute kawasaki medical school
Institute
Department

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
Email 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
2019 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016378

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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