UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004968 |
|---|---|
| Receipt number | 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 15:35:38 |
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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
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
d-tsuji@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
Department of Clinical Pharmacology and Genitics, School of Pharmaceutical Science, Univercity of Shizuoka
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005834
| 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 |
