UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023259 |
|---|---|
| Receipt number | R000026802 |
| Scientific Title | Study of tenetic profiling and immune response of thoracic and solid cancers using clinical specimens |
| Date of disclosure of the study information | 2016/07/21 |
| Last modified on | 2016/07/20 20:16:30 |
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Basic information
Public title
Study of tenetic profiling and immune response of thoracic and solid cancers using clinical specimens
Acronym
Genetic profiling and immune response of thoracic and solid cancers
Scientific Title
Study of tenetic profiling and immune response of thoracic and solid cancers using clinical specimens
Scientific Title:Acronym
Genetic profiling and immune response of thoracic and solid cancers
Region
| Japan |
Condition
Condition
Solid cancer
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
By analyzing genetic expression and immune profiling of clinical specimens from patients with thoracic and other solid tumor who are planned for or treated with anti-cancer treatment, changes related to efficacy or safety will be evaluated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Response to treatment by RECIST
Key secondary outcomes
Safety (evaluated by CTCAE)
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
Patients who are treated by any anti-cancer therapy in our institution.
Patients who have at leas one specimen to analyze
Patients who agreed to this study
Key exclusion criteria
none
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Goto |
Organization
National Cancer Center Hospital
Division name
Thoracic Oncology
Zip code
Address
5-1-1 Tsukiji Chuoku Tokyo
TEL
03-3542-2511
ygoto@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Goto |
Organization
National Cancer Center Hospital
Division name
Thoracic Oncology
Zip code
Address
5-1-1 Tsukiji Chuoku Tokyo
TEL
03-3542-2511
Homepage URL
ygoto@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 07 | Month | 21 | 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
| 2015 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observing clinical course and related factors.
Management information
Registered date
| 2016 | Year | 07 | Month | 20 | Day |
Last modified on
| 2016 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026802
