UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037174 |
|---|---|
| Receipt number | 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 21:44:53 |
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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
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
t.sawada@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University, School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042357
