UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041056 |
|---|---|
| Receipt number | 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 23:56:43 |
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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
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
hiroaki.kanemura@med.kindai.ac.jp
Sponsor or person
Institute
Kindai university, Faculty of Medicine, Department of Medical Oncology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046886
