UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001892 |
|---|---|
| Receipt number | R000002174 |
| Scientific Title | Association between genetic polymorphism and adverse events or effectiveness of S-1-based chemotherapy in patients with gastrointestinal cancer |
| Date of disclosure of the study information | 2009/04/16 |
| Last modified on | 2012/10/16 23:14:08 |
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Basic information
Public title
Association between genetic polymorphism and adverse events or effectiveness of S-1-based chemotherapy in patients with gastrointestinal cancer
Acronym
TCO-TYMS2009
Scientific Title
Association between genetic polymorphism and adverse events or effectiveness of S-1-based chemotherapy in patients with gastrointestinal cancer
Scientific Title:Acronym
TCO-TYMS2009
Region
| Japan |
Condition
Condition
gastrointestinal cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate the association between genetic polymorphisms and adverse events or effectiveness of S-1-based chemotherapy in patients with gastrointestinal cancer
Basic objectives2
Others
Basic objectives -Others
Phagmacogenetics
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of adverse events
Key secondary outcomes
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. Patients who either completed, currently recieving, or are going to receive S-1-based chemotherapy at Outpatient Oncology Unit, Kyoto University Hospital
2. Patients who have histologically confirmed, unresectable advanced or recurrent gastric, pancreatic, biliary tract or colorectal cancer
3. Patients who provided written informed consent
Key exclusion criteria
1. Patients with at least 6 months S-1 free interval if they were re-treated by S-1-based chemotherapy (e.g. recurrence after adjuvant chemotherapy)
2. Patients who were judged ineligible by investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takafumi Nishimura |
Organization
Kyoto University Hospital
Division name
Outpatient Oncology Unit
Zip code
Address
54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takafumi Nishimura |
Organization
Kyoto University Hospital
Division name
Outpatient Oncology Unit
Zip code
Address
TEL
Homepage URL
nisimura@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Taiho Pharmaceutical
Organization
Division
Category of Funding Organization
Profit organization
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
| 2009 | Year | 04 | Month | 16 | 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
Completed
Date of protocol fixation
| 2009 | Year | 03 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
TYMS, UMPS, DPYD, MTHR
Management information
Registered date
| 2009 | Year | 04 | Month | 16 | Day |
Last modified on
| 2012 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002174
