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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041056
Receipt No. R000046886
Scientific Title Comprehensive analysis of tumor immune microenvironment in small cell lung cancer
Date of disclosure of the study information 2020/07/15
Last modified on 2020/07/09

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Basic information
Public title Comprehensive analysis of tumor immune microenvironment in small cell lung cancer
Acronym Tumor immune microenvironment in SCLC
Scientific Title Comprehensive analysis of tumor immune microenvironment in small cell lung cancer
Scientific Title:Acronym Tumor immune microenvironment in SCLC
Region
Japan

Condition
Condition Small cell lung cancer (SCLC)
Classification by specialty
Medicine in general Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Primary objective:
To evaluate the immune profile of SCLC
To investigate the association of tumor mutation burden (TMB) and T-cell inflamed gene expression , and the clinical outcome of cytotoxic agents and ICI.
Secondary objectives:
To explore the immune suppressive markers and genetic characterizations associated with clinical outcome of ICI in SCLC
Basic objectives2 Others
Basic objectives -Others Evaluation of biomarkers
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The frequency of SCLC patients characterized by TMB and T-cell inflamed gene expression profile
Key secondary outcomes The association of the efficacy, OS, PFS, 6 months PFS rate, and ORR of cytotoxic agents as well as ICI and biomarker candidates.

The association among biomarker candidates.

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 Male or female patients 20 years or older
Patients with histologically or cytologically confirmed SCLC
Patients who received at least dose of cytotoxic agents or ICI
Key exclusion criteria Patients who never received cytotoxic agents or ICI
Target sample size 340

Research contact person
Name of lead principal investigator
1st name Hidetoshi
Middle name
Last name Hayashi
Organization Kindai University, Faculty of Medicine
Division name Department of Medical Oncology
Zip code 589-8511
Address 377-2, Ohno-higashi, Osakasayama City, Osaka
TEL 072-366-0221
Email hidet31@med.kindai.ac.jp

Public contact
Name of contact person
1st name Hiroaki
Middle name
Last name Kanemura
Organization Kindai University, Faulty of Medicine
Division name Department of Medical Oncology
Zip code 589-8511
Address 377-2, Ohno-higashi, Osakasayama City, Osaka
TEL 072-366-0221
Homepage URL
Email hiroaki.kanemura@med.kindai.ac.jp

Sponsor
Institute Kindai university, Faculty of Medicine, Department of Medical Oncology
Institute
Department

Funding Source
Organization Chugai Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kindai University, Department of Medical Oncology, Faculty of Medicine
Address 377-2, Ohno-higashi, Osakasayama City, Osaka, 589-8511
Tel 072-366-0221
Email hiroaki.kanemura@med.kindai.ac.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 近畿大学医学部内科学腫瘍内科部門(大阪府)
市立岸和田市民病院(大阪府)
和泉市立総合医療センター(大阪府)
近畿大学奈良病院(奈良県)
独立行政法人国立病院機構大阪南医療センター(大阪府)
大原記念倉敷中央医療機構倉敷中央病院(岡山県)
聖路加国際病院(東京都)
大阪市立大学医学部付属病院(大阪府)

Other administrative information
Date of disclosure of the study information
2020 Year 07 Month 15 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 340
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 No longer recruiting
Date of protocol fixation
2020 Year 02 Month 28 Day
Date of IRB
2020 Year 03 Month 14 Day
Anticipated trial start date
2020 Year 03 Month 15 Day
Last follow-up date
2021 Year 10 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Comprehensive analysis of tumor immune microenvironment in small cell lung cancer

Management information
Registered date
2020 Year 07 Month 09 Day
Last modified on
2020 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046886

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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