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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043798
Receipt No. R000049987
Scientific Title Exploratory study of biomarkers for therapeutic efficacy and immune-related adverse events of immune checkpoint inhibitors
Date of disclosure of the study information 2021/04/01
Last modified on 2021/03/31

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Basic information
Public title Exploratory study of biomarkers for therapeutic efficacy and immune-related adverse events of immune checkpoint inhibitors
Acronym Biomarkers of immune checkpoint inhibitors
Scientific Title Exploratory study of biomarkers for therapeutic efficacy and immune-related adverse events of immune checkpoint inhibitors
Scientific Title:Acronym Biomarkers of immune checkpoint inhibitors
Region
Japan

Condition
Condition All cancer types indicated for immune checkpoint inhibitor
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Cardiology Pneumology Endocrinology and Metabolism
Hematology and clinical oncology Nephrology Neurology
Clinical immunology Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Endocrine surgery Breast surgery Obsterics and gynecology
Dermatology Oto-rhino-laryngology Urology
Oral surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The purpose of this study is to explore for genetic factors involved in therapeutic efficacy and irAE by Genome Wide Association Study in order to develop biomarkers of immune checkpoint inhibitors.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Identification of genetic factors associated with immune-related adverse events
Key secondary outcomes Identification of genetic factors associated with the therapeutic effects of immune checkpoint inhibitors

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 1. Cancer patients who are scheduled to receive, or have received, immune checkpoint inhibitors at our hospital or related facilities.
2. 20 years of age or older with the ability to make decisions for themselves.
Key exclusion criteria The patient whom the researcher consider to be inappropriate for the study.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Yasuhito
Middle name
Last name Tanaka
Organization Faculty of Life Sciences, Kumamoto University
Division name Department of Gastroenterology and Hepatology
Zip code 860-8556
Address 1-1-1 Honjo, Chuo-ku, Kumamoto,
TEL 09637375150
Email ytanaka@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name Hideaki
Middle name
Last name Miyamoto
Organization Faculty of Life Sciences, Kumamoto University
Division name Department of Gastroenterology and Hepatology
Zip code 860-8556
Address 1-1-1 Honjo, Chuo-ku
TEL 0963735150
Homepage URL
Email hidemyam@kuh.kumamoto-u.ac.jp

Sponsor
Institute Kumamoto University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Faculty of Life Sciences, Kumamoto University
Address 1-1-1 Honjo, Chuo-ku, Kumamoto
Tel 0963735657
Email ski-shien@jimu.kumamoto-u.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 名古屋市立大学 大学院医学研究科(愛知県)
国立大学法人金沢大学(石川県)
武蔵野赤十字病院(東京都)
国立大学法人北海道大学 北海道大学病院(北海道)
国立病院機構長崎医療センター(長崎県)
国立大学法人徳島大学 大学院医歯薬学研究部(徳島県)
医療法人渓仁会 手稲渓仁会病院(北海道)
国立大学法人群馬大学大学院医学系研究科(群馬県)
聖マリアンナ医科大学(神奈川県)
学校法人北里研究所 北里大学医学部(神奈川県)
岐阜大学医学部附属病院(岐阜県)
大垣市民病院(岐阜県)
独立行政法人地域医療機能推進機構中京病院(愛知県)
名古屋第二赤十字病院(愛知県)
京都府公立大学法人京都府立医科大学 大学院医学研究科(京都府)
奈良県立医科大学(奈良県)
公立大学法人大阪大阪市立大学大学院医学研究科(大阪府)
愛媛大学大学院医学系研究科(愛媛県)
川崎医科大学(岡山県)
久留米大学医学部(福岡県)
長崎大学病院(長崎県)
おおたかの森病院(千葉県)
日本医科大学付属病院(東京都)
日本医科大学千葉北総病院(千葉県)
名古屋大学医学部付属病院(愛知県)
仙台厚生病院(宮城県)
佐賀大学医学部付属病院(佐賀県)
山鹿市民医療センター(熊本県)
くまもと県北病院(熊本県)
熊本医療センター(熊本県)
熊本赤十字病院(熊本県)
大牟田天領病院(福岡県)
くまもと森都総合病院(熊本県)
労働者健康福祉機構 熊本労災病院(熊本県)
熊本市医師会熊本地域医療センター(熊本県)
済生会熊本病院(熊本県)
地域医療機能推進機構熊本総合病院(熊本県)
国保水俣市立総合医療センター(熊本県)
天草郡市医師会 天草地域医療センター(熊本県)
藤田医科大学(愛知県)
愛媛県立中央病院(愛知県)
横浜市立大学附属市民総合医療センター(神奈川県)
済生会新潟病院(新潟県)
香川県立中央病院(香川県)
国立病院機構九州医療センター(福岡県)
旭中央病院(千葉県)
東海大学医学部(神奈川県)

Other administrative information
Date of disclosure of the study information
2021 Year 04 Month 01 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 Enrolling by invitation
Date of protocol fixation
2021 Year 02 Month 11 Day
Date of IRB
2021 Year 03 Month 10 Day
Anticipated trial start date
2021 Year 03 Month 12 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information DNA is extracted from blood samples and GWAS is performed.

Management information
Registered date
2021 Year 03 Month 31 Day
Last modified on
2021 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049987

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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