UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049431 |
|---|---|
| Receipt number | R000056282 |
| Scientific Title | A study on immune-related adverse events in early phase clinical trials |
| Date of disclosure of the study information | 2022/11/04 |
| Last modified on | 2024/05/06 11:26:33 |
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Basic information
Public title
A study on immune-related adverse events in early phase clinical trials
Acronym
A study on immune-related adverse events in early phase clinical trials
Scientific Title
A study on immune-related adverse events in early phase clinical trials
Scientific Title:Acronym
A study on immune-related adverse events in early phase clinical trials
Region
| Japan |
Condition
Condition
cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the utility and validity of comprehensive analysis of cytokines, immune cells, etc. in early phase clinical trials by conducting immunological profiling of clinical samples (blood samples, tumor cells and non-tumor tissues from patients who are participating, will participate, or are likely to participate in early phase clinical trials.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To verify the usefulness and validity of comprehensive analysis of cytokines, immune cells, etc. in early clinical trials.
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with individual consent for "Research on Collection and Storage of Clinical Specimens in Early Clinical Trials (for Future Exploratory Studies) (Research Project No. 2017-475)" who have blood and tissue specimens available for use
Key exclusion criteria
none
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Katsuya |
Organization
National cancer center hospital
Division name
Department of experimental development
Zip code
1040045
Address
5-1-1, Chuo-ku, Tsukiji, Tokyo
TEL
0335422511
ykatsuya@ncc.go.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Katsuya |
Organization
National Cancer Center Hospital
Division name
Department of experimental development
Zip code
1040045
Address
5-1-1, Tsukiji, Chuo-ku
TEL
0335422511
Homepage URL
ykatsuya@ncc.go.jp
Sponsor or person
Institute
national cancer center hospital
Institute
Department
Personal name
Funding Source
Organization
national cancer center hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National cancer center
Address
5-1-1, CHu0ku, Tsukiji, Tokyo
Tel
0335422511
irst@ml.res.ncc.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2022-140
Org. issuing International ID_1
Natinal cancer center
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 04 | 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
| 2022 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Analysis of immune environment and anti-malignant tumor by analyzing comprehensive cytokines in blood and tumor-infiltrating immune cells using temporarily preserved specimens in "Study on clinical specimen collection and storage in early clinical trials (research project number 2017-475)", during, and after administration of anti-cancer drugs.
Management information
Registered date
| 2022 | Year | 11 | Month | 04 | Day |
Last modified on
| 2024 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056282
