UMIN-CTR Clinical Trial

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