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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004968
Receipt No. R000005834
Scientific Title A pharmacogenomics study for adverse effects and clinical outcome to S-1 in gastric cancer patients
Date of disclosure of the study information 2011/02/10
Last modified on 2018/08/03

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Basic information
Public title A pharmacogenomics study for adverse effects and clinical outcome to S-1 in gastric cancer patients
Acronym Pharmacogenomics study for individual response to S-1
Scientific Title A pharmacogenomics study for adverse effects and clinical outcome to S-1 in gastric cancer patients
Scientific Title:Acronym Pharmacogenomics study for individual response to S-1
Region
Japan

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

Objectives
Narrative objectives1 To investigate the distributions of polymorphisms and their association with adverse drug reactions to S-1 in gastric cancer patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes To investigate the single nucleotide polymorphisms correlated with S-1 induced adverse drug reactions
Key secondary outcomes 1) To investigate the single nucleotide polymorphisms correlated with progression-free survival (advanced gastric cancer)

2) To investigate the single nucleotide polymorphisms correlated with recurrence-free survival (resectable gastric cancer)

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_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 Gastric cancer
2) Life expectancy of at least 12 weeks at the pre-treatment evaluation
3) No prior chemotherapy or radiotherapy before enrollment
4) Oral intake is possible
5) 20 years of age or older
6) ECOG PS 0-2
7) Adequate organ function obtained within 2 weeks prior to registration. Laboratory values must be as follows;
WBC count >= 3,000 /mm3, and <= 12,000 /mm3
absolute neutrophil count >= 1,500 /mm3,
hemoglobin >= 8.0 g/dL
platelet count >= 100,000 /mm3
AST <= 100 IU/L
ALT <= 100 IU/L
total bilirubin less than or equal to 1.5 mg/dL
serum creatinine <= 1.5 mg/dL
8)Informed consent by the document
Key exclusion criteria 1) Known prior severe hypersensitivity to clinical trial medicines
2) Patients who do not have enough whole body state to the antineoplastic agents treatment
3) Pregnant, breastfeeding or expecting woman
4) Other clinical difficulties in this study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daiki Tsuji
Organization Univercity of Shizuoka
Division name School of Pharmaceutical Science
Zip code
Address 52-1, Yada, Suruga-ku, Shizuoka, 422-8526, Japan
TEL 054-264-5674
Email d-tsuji@u-shizuoka-ken.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daiki Tsuji
Organization Univercity of Shizuoka
Division name School of Pharmaceutical Science
Zip code
Address 52-1, Yada, Suruga-ku, Shizuoka, 422-8526, Japan
TEL 054-264-5674
Homepage URL
Email d-tsuji@u-shizuoka-ken.ac.jp

Sponsor
Institute Department of Clinical Pharmacology and Genitics, School of Pharmaceutical Science, Univercity of Shizuoka
Institute
Department

Funding Source
Organization None
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
2011 Year 02 Month 10 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 Open public recruiting
Date of protocol fixation
2010 Year 12 Month 17 Day
Date of IRB
Anticipated trial start date
2011 Year 02 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 Blood samples are collected from gastric cancer patients before S-1 oral administration. Relationship between adverse drug reactions of S-1 and genitic polymorphisms are assessed.

Management information
Registered date
2011 Year 01 Month 27 Day
Last modified on
2018 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005834

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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