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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000015415
Receipt No. R000017926
Scientific Title The relationship between ocular toxicity induced by S-1 and pharmacokinetic analysis in both blood and tear
Date of disclosure of the study information 2014/11/01
Last modified on 2018/10/06

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Basic information
Public title The relationship between ocular toxicity induced by S-1 and pharmacokinetic analysis in both blood and tear
Acronym The relationship between ocular toxicity induced by S-1 and pharmacokinetic analysis in both blood and tear
Scientific Title The relationship between ocular toxicity induced by S-1 and pharmacokinetic analysis in both blood and tear
Scientific Title:Acronym The relationship between ocular toxicity induced by S-1 and pharmacokinetic analysis in both blood and tear
Region
Japan

Condition
Condition Malignancy
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 We evaluate the relationship between ocular toxicity induced by S-1 and drug concentrations in both blood and tear. Furthermore, we analyze genetic polymorphisms that relate with the metabolism of S-1.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To identify the pharmacokinetic factors that is associated with ocular toxicity induced by S-1
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 Treatment
Type of intervention
Medicine
Interventions/Control_1 S-1
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 1) Histologically or cytologically confirmed malignancy
2) Advanced cancers that S-1 are effective or gastric cancers that S-1 is indicated as adjuvant chemotherapy
3) Age is over 20 years.
4) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
5)Adequate organ function, evidenced by following laboratory results within 14 days prior to starting chemotherapy.
Absolute neutrophil count>1,500/mm3
Platelet count<100,000/mm3
Hemoglobin<8.0g/dl
Total bilirubin<2.0mg/dl
AST and ALT<2.5 times the upper limit of normal(ULN)
Creatinine<1.5mg/dl
6)Signed, written informed concent is obtained.
Key exclusion criteria 1) interstitial pneumonia, pulmonary fibrosis
2) Severe active infection
3) Serological positive for HBs-antigen or HCV-antibody
4) Unstable angina or myocardial infarction within 3 months
5) Severe complication (e.g., uncontrollable diabetis mellitus, liver disease)
6) Active synchronous cancer
7) Severe psychiatric disorder
8) Pregnant or lactating women, or men and women without wanting pregnancy
9) Severe hypersensitivity to medicine
10) Patients who were judged inappropriate for the study
Target sample size 100

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yasutsuna Sasaki
Organization Showa University School of Medicine
Division name Division of Medical Oncology, Department of Medicine
Zip code
Address 1-5-8 Hatanodai, Shinagawa, Tokyo
TEL 03-3784-8000
Email yasutsuna@med.showa-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Hiroo Ishida
Organization Showa University School of Medicine
Division name Division of Medical Oncology, Department of Medicine
Zip code
Address 1-5-8 Hatanodai, Shinagawa, Tokyo
TEL 03-3784-8000
Homepage URL
Email hishida@med.showa-u.ac.jp

Sponsor
Institute Showa University School of Medicine
Institute
Department

Funding Source
Organization Showa University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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
2014 Year 11 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
2014 Year 09 Month 11 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 01 Day
Last follow-up date
2018 Year 09 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
2014 Year 10 Month 11 Day
Last modified on
2018 Year 10 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017926

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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