UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041803 |
|---|---|
| Receipt number | R000047712 |
| Scientific Title | Clinical significance of peripheral blood CD4+ T cell subpopulations for immune checkpoint inhibitor treatment |
| Date of disclosure of the study information | 2020/09/20 |
| Last modified on | 2020/09/15 15:51:33 |
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Basic information
Public title
Clinical significance of peripheral blood CD4+ T cell subpopulations for immune checkpoint inhibitor treatment
Acronym
peripheral blood CD4+ T cell subpopulations for immune checkpoint inhibitor treatment
Scientific Title
Clinical significance of peripheral blood CD4+ T cell subpopulations for immune checkpoint inhibitor treatment
Scientific Title:Acronym
peripheral blood CD4+ T cell subpopulations for immune checkpoint inhibitor treatment
Region
| Japan |
Condition
Condition
Patients with gastrointestinal, hepatobilial, urological, or otorhinolaryngological cancer treated with an immune chekpoint inhibitor
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Oto-rhino-laryngology | Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether baseline peripheral blood CD4+ T cell subpopulations could be a therapeutic predictor for patients treated with innume checkpoint inhibitors
Basic objectives2
Others
Basic objectives -Others
To investigate the relationship between the T cell subpopulations and adverse events
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
overall survival
Key secondary outcomes
progression-free survival
objective response rate
adverse events during the treatment
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients whom written informed consents of the study are obtained from
Key exclusion criteria
patients with past history of an immune checkpoint inhibitor
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yoshimichi |
| Middle name | |
| Last name | Haruna |
Organization
Osaka General Medical Center
Division name
Department of Laboratory Medicine
Zip code
558-8558
Address
3-1-56 Bandaihigashi, Sumiyoshiku, Osaka
TEL
06-6692-1201
apple-123-grape@ab.auone-net.jp
Public contact
Name of contact person
| 1st name | Yoshimichi |
| Middle name | |
| Last name | Haruna |
Organization
Osaka General Medical Center
Division name
Department of Laboratory Medicine
Zip code
558-8558
Address
3-1-56 Bandaihigashi, Sumiyoshiku, Osaka
TEL
06-6692-1201
Homepage URL
apple-123-grape@ab.auone-net.jp
Sponsor or person
Institute
Osaka General Medical Center
Institute
Department
Personal name
Funding Source
Organization
Osaka General Medical Center
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
Osaka General Medical Center
Address
3-1-56 Bandaihigashi, Sumiyoshiku, Osaka
Tel
06-6692-1201
kenkyusien@gh.opho.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
| 2020 | Year | 09 | Month | 20 | 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
| 2020 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Forty patients will be investigated in each group of gastrointestinal and hepatobilial cancers, urological cancers or otorhinolaryngological cancers.
Management information
Registered date
| 2020 | Year | 09 | Month | 15 | Day |
Last modified on
| 2020 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047712
