UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035567 |
|---|---|
| Receipt number | R000040522 |
| Scientific Title | An exploratory study to evaluate biomarkers of prospective multicenter observational study of atezolizumab in patients with locally advanced or metastatic non-small cell lung cancer :J-TAIL |
| Date of disclosure of the study information | 2019/01/16 |
| Last modified on | 2024/01/22 08:49:35 |
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Basic information
Public title
An exploratory study to evaluate biomarkers of prospective multicenter observational study of atezolizumab
in patients with locally advanced or metastatic non-small cell lung cancer :J-TAIL
Acronym
An exploratory study to evaluate biomarkers of J-TAIL
Scientific Title
An exploratory study to evaluate biomarkers of prospective multicenter observational study of atezolizumab
in patients with locally advanced or metastatic non-small cell lung cancer :J-TAIL
Scientific Title:Acronym
An exploratory study to evaluate biomarkers of J-TAIL
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore biomarkers in blood to select appropriate patients with locally advanced or metastatic non-small cell lung cancer for atezolizumab
Basic objectives2
Others
Basic objectives -Others
Biomarker Research
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the correlation of values of protein expressions, concentrations of atezolizumab and molecular and functional profiling of T-cell differentiation in peripheral blood with efficacy and safety
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
Patients enrolled in J-TAIL study and singed informed consent
Key exclusion criteria
NONE
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | 1. Tetsuya, 2. Akihiko, 3. Ichiro, 4. Makoto |
| Middle name | |
| Last name | 1. MITSUDOMI 2. GEMMA 3. YOSHINO 4. NISHIO |
Organization
1. Kindai University
2. Nippon medical school
3. Chiba University
4. The Cancer Institute Hospital
Division name
1. Division of Thoracic Surgery 2. Department of pulmonary medicine and oncology 3. Department of General Thoracic Surgery 4. Department of Thoracic Medical Oncology
Zip code
1.589-8511, 2.113-8602, 3.260-8677, 4.135-8550
Address
1. 377-2 Ohno-Higashi, Osaka-Sayama, Japan 2. 1-1-5, Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan 3. 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan 4. 3-8-31 Ariake, Koto-ku, Tokyo, Japan
TEL
0723660221.0338222131.0432227171.0335200111
1.mitsudom@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Hayato |
| Middle name | |
| Last name | Konishi |
Organization
MEBIX INC.
Division name
CLINICAL OPERATIONS
Zip code
105-0001
Address
3-8-21 Toranomon, Minatoku, Tokyo, Japan
TEL
03-4362-4504
Homepage URL
j-tail@mebix.co.jp
Sponsor or person
Institute
Medical Affairs,
CHUGAI PHARMACEUTICAL CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
CHUGAI PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
The Japan Lung Cancer Society
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization MINS Institutional Review Board
Address
1-15-14, Dogenzaka, Shibuya, Tokyo, Japan
Tel
0364161868
Npo-mins@j-irb.com
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
| 2019 | Year | 01 | 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
Main results already published
Date of protocol fixation
| 2018 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 16 | Day |
Date of closure to data entry
| 2021 | Year | 07 | Month | 07 | Day |
Date trial data considered complete
| 2021 | Year | 07 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Efficacy, Safety
Management information
Registered date
| 2019 | Year | 01 | Month | 16 | Day |
Last modified on
| 2024 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040522
| 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 |
