UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043268 |
|---|---|
| Receipt number | R000049385 |
| Scientific Title | Analysis of lymphocyte composition of the intestinal tract and peripheral blood in patients treated with immune checkpoint inhibitors |
| Date of disclosure of the study information | 2021/02/08 |
| Last modified on | 2021/02/06 20:33:23 |
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Basic information
Public title
Analysis of lymphocyte composition of the intestinal tract and peripheral blood in patients treated with immune checkpoint inhibitors
Acronym
Analysis of lymphocytes in patients treated with immune checkpoint inhibitors
Scientific Title
Analysis of lymphocyte composition of the intestinal tract and peripheral blood in patients treated with immune checkpoint inhibitors
Scientific Title:Acronym
Analysis of lymphocytes in patients treated with immune checkpoint inhibitors
Region
| Japan |
Condition
Condition
patients treated with immune checkpoint inhibitors
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the differences of lymphocyte composition in the intestine and peripheral blood in patients with and without irAE (immune-related Adverse Events) enteritis who treated with immune checkpoint inhibitors
Basic objectives2
Others
Basic objectives -Others
To reveal the clinical characteristic of the patients treated with immune checkpoint inhibitors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
lymphocyte composition of the intestinal tract and peripheral blood in patients treated with immune checkpoint inhibitors
Key secondary outcomes
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients treated with immune checkpoint inhibitors
Key exclusion criteria
Pregnant patients
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Iwamuro |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
0862357218
iwamuromasaya@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Iwamuro |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
0862357218
Homepage URL
iwamuromasaya@yahoo.co.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Okayama University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
Tel
0862357218
iwamuromasaya@yahoo.co.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
| 2021 | Year | 02 | Month | 08 | 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 | 05 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 08 | Day |
Last follow-up date
| 2022 | 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
| 2021 | Year | 02 | Month | 06 | Day |
Last modified on
| 2021 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049385
