UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031076 |
|---|---|
| Receipt number | R000035487 |
| Scientific Title | Analysis of immune status in non-small cell lung cancer patients with EGFR mutations |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2019/09/10 11:19:03 |
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Basic information
Public title
Analysis of immune status in non-small cell lung cancer patients with EGFR mutations
Acronym
Analysis of immune status in NSCLC with EGFR mutations
Scientific Title
Analysis of immune status in non-small cell lung cancer patients with EGFR mutations
Scientific Title:Acronym
Analysis of immune status in NSCLC with EGFR mutations
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate immune status of non-small cell lung cancer patients with EGFR mutations who receive EGFR-TKIs
Basic objectives2
Others
Basic objectives -Others
Search for biomarkers
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of immune cells in tumor-infiltrating lymphocytes from pre- to post-treatment with EGFR-TKIs.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients with advanced EGFR-mutated NSCLC receiving EGFR-TKIs as 1st line treatment whose tumor samples pre- and post-treatment are surplus will be enrolled in this study. Patients who already treated EGFR-TKI with archive samples will be also enrolled in this study.
Key exclusion criteria
Patients who are not feasible for biopsy will be excluded.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroyoshi |
| Middle name | |
| Last name | Nishikawa |
Organization
National Cancer Center
Division name
Division of Cancer Immunology
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
0471331111
hnishika@ncc.go.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Togashi |
Organization
National Cancer Center
Division name
Division of Cancer Immunology
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
0471331111
Homepage URL
ytogashi1584@gmail.com
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca K.K.
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
National Cancer Center
Address
6-5-1 Kashiwanoha
Tel
0471331111
irst@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
国立がん研究センター東病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Immune status of tumor microenvironment is analyzed.
Management information
Registered date
| 2018 | Year | 01 | Month | 31 | Day |
Last modified on
| 2019 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035487
