UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011141 |
|---|---|
| Receipt number | R000013046 |
| Scientific Title | Trial of Onco-Panel for Geneprofiling to Estimate both Adverse events and Response by cancer treatment |
| Date of disclosure of the study information | 2013/07/09 |
| Last modified on | 2019/07/13 13:21:02 |
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Basic information
Public title
Trial of Onco-Panel for Geneprofiling to Estimate both Adverse events and Response by cancer treatment
Acronym
TOP-GEAR
Scientific Title
Trial of Onco-Panel for Geneprofiling to Estimate both Adverse events and Response by cancer treatment
Scientific Title:Acronym
TOP-GEAR
Region
| Japan |
Condition
Condition
Cancer patient who will receive chemotherapy
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Genprofiling to estimate both adverse events and response of chemotherapy in cancer patients
Basic objectives2
Others
Basic objectives -Others
Geneprofiling
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Analysis of somatic gene mutation, gene expression of tumor tissue
Key secondary outcomes
Polymorphism analysis of genes related to the pharmacodynamics and pharmacokinetics in non-tumor tissue
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
| 1 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Cancer patient who will recieve chemotherapy
2) Age over 1 year
3) Samples meeting one of the followings:
3)-1Tumor tissue
i) Surplus sample stored in the NCC biobank
ii) Surplus sample of diagnostic biopsy
iii) Surgical surplus tumor sample
iv) Newly-taken tumor sample for this study
3)-2 Non-tumor tissue
i) Surplus tissue and blood in the NCC biobank
ii) Newly-taken blood (5-20mL) for this study
iii) Newly-taken oral mucosa for this study
iv) Newly-taken non-tumor gastrointestinal mucosa for this study
4) Written informed consent
Key exclusion criteria
1) Judged ineligible by the clinical investigators
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Noboru |
| Middle name | |
| Last name | Yamamoto |
Organization
National Cancer Center Hospital
Division name
Department of Experimental Therapeutics
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
nbryamam@ncc.go.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Kondo |
Organization
National Cancer Center Hospital
Division name
Department of Experimental Therapeutics
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
shkondo@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Hospital Certified Review Board
Address
5-1-1 Tsukiji, Chuo-ku
Tel
03-3542-2511
ncch-irb@ml.res.ncc.go.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
| 2013 | Year | 07 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2013 | Year | 07 | Month | 07 | Day |
Last modified on
| 2019 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013046
| 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 |
