UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051528 |
|---|---|
| Receipt number | R000058792 |
| Scientific Title | A retrospective study to explore the biomarkers in lung cancer immunotherapy, 2nd stage -irAE prediction- |
| Date of disclosure of the study information | 2023/07/06 |
| Last modified on | 2023/07/05 16:33:36 |
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Basic information
Public title
A retrospective study to explore the biomarkers in lung cancer immunotherapy, 2nd stage -irAE prediction-
Acronym
LC-SCRUM-IBIS-II_irAE
Scientific Title
A retrospective study to explore the biomarkers in lung cancer immunotherapy, 2nd stage -irAE prediction-
Scientific Title:Acronym
Immuno-Oncology Biomarker Study-II_irAE (LC-SCRUM-IBIS-II_irAE)
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To explore new biomarkers of immune-related adverse events (irAE) in immunotherapies for lung cancer
Basic objectives2
Others
Basic objectives -Others
To explore the association between irAE and HLA alleles
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
HLA alleles
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients whose whole exome sequence data have been collected in the LC-SCRUM-IBIS study.
2) Patients who consented to the secondary use of the genetic analysis data and clinical information.
Key exclusion criteria
Not applicable
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Goto |
Organization
National Cancer Center Hospital East
Division name
Department of Thoracic Oncology
Zip code
277-0882
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL
04-7133-1111
kgoto@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Kaname |
| Middle name | |
| Last name | Nosaki |
Organization
National Cancer Center Hospital East
Division name
Department of Thoracic Oncology
Zip code
277-0882
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL
04-7133-1111
Homepage URL
knosaki@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
CHUGAI PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee at National Cancer Center
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.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
| 2023 | Year | 07 | Month | 06 | 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
| 2023 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To explore new biomarkers of immune-related adverse events (irAE) in immunotherapies for lung cancer.
Management information
Registered date
| 2023 | Year | 07 | Month | 05 | Day |
Last modified on
| 2023 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058792
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
