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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037174
Receipt No. R000042357
Scientific Title Study on gastrointestinal and hepatic side effects induced by immunity checkpoint inhibitors
Date of disclosure of the study information 2019/08/01
Last modified on 2019/07/16

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Basic information
Public title Study on gastrointestinal and hepatic side effects induced by immunity checkpoint inhibitors
Acronym Analysis of gastrointestinal and hepatic side effects induced by immunity checkpoint inhibitors
Scientific Title Study on gastrointestinal and hepatic side effects induced by immunity checkpoint inhibitors
Scientific Title:Acronym Analysis of gastrointestinal and hepatic side effects induced by immunity checkpoint inhibitors
Region
Japan

Condition
Condition Cancer patients treated with immune checkpoint inhibitors
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify clinical features in patients with gastrointestinal and hepatic side effects induced by immunity checkpoint inhibitors
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Examination of clinical,endoscopic and histopathological features of irAE
Key secondary outcomes Examination of factors related to the severity of irAE and treatment response

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who developed Grade 2 or higher digestive-related adverse events using immune checkpoint inhibitors at our hospital
Patients who understood the contents of this study and obtained written consent to participate in the study
Key exclusion criteria Patients wishing to be excluded from the study
If the principal investigator or co-investigator determines that the research participation is ineligible for other reasons
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Mitsuhiro
Middle name
Last name Fujishiro
Organization Nagoya University
Division name Gastroenterology and Hepatology
Zip code 466-8550
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan
TEL 052-744-2172
Email mtfujish@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Tsunaki
Middle name
Last name Sawada
Organization Nagoya University
Division name Gastroenterology and Hepatology
Zip code 466-8550
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan
TEL 052-744-2172
Homepage URL
Email t.sawada@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University, School of Medicine
Institute
Department

Funding Source
Organization Nagoya University, School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Nagoya University School of Medicine Clinical Research Review Committee
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan
Tel 052-744-2479
Email ethics@med.nagoya-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

Other administrative information
Date of disclosure of the study information
2019 Year 08 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 Preinitiation
Date of protocol fixation
2019 Year 06 Month 25 Day
Date of IRB
Anticipated trial start date
2019 Year 08 Month 01 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 None

Management information
Registered date
2019 Year 06 Month 25 Day
Last modified on
2019 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042357

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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