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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035567
Receipt No. 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 2019/07/29

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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
Email 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
Email j-tail@mebix.co.jp

Sponsor
Institute Medical Affairs,
CHUGAI PHARMACEUTICAL CO., LTD.
Institute
Department

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
Email 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 Open public recruiting
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
2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Efficacy, Safety

Management information
Registered date
2019 Year 01 Month 16 Day
Last modified on
2019 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040522

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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