UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047162 |
|---|---|
| Receipt number | R000053799 |
| Scientific Title | Investigation of biomarkers to predict immune-related adverse events in patients with non-small cell lung cancer |
| Date of disclosure of the study information | 2022/05/01 |
| Last modified on | 2022/03/13 11:50:54 |
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Basic information
Public title
Investigation of biomarkers to predict immune-related adverse events in patients with non-small cell lung cancer
Acronym
Biomarkers to predict irAEs in patients with NSCLC
Scientific Title
Investigation of biomarkers to predict immune-related adverse events in patients with non-small cell lung cancer
Scientific Title:Acronym
Biomarkers to predict irAEs in patients with NSCLC
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigation for molecular markers that enable the prediction or early detection of immune-related adverse events in the combination of chemotherapy and immunotherapy for non-small cell lung cancer
Basic objectives2
Others
Basic objectives -Others
Exploratory research
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Onset of drug-induced interstitial lung disease
Key secondary outcomes
Onset of immune-related adverse events
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. The age at the time of obtaining consent is 20 years or older.
2. Diagnosed as non-small cell lung cancer.
3. chemo-IO is planned.
4. Expected to survive for more than 6 months after registration.
5. Written consent is obtained.
Key exclusion criteria
1. Patients with active double cancer (simultaneous double cancer and metachronous double cancer with no disease period within 3 years).
2. Patients with ILD complications prior to treatment (Intestinal Lung Abnormality (ILA) is acceptable).
3. Patients with autoimmune disease.
4. Patients taking 10 mg or more of prednisolone.
5. Patients who the principal investigator deems inappropriate for this study.
Target sample size
114
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Nagano |
Organization
Kobe University Hospital
Division name
Respiratory Medicine
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL
0783825660
tnagano@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Nagano |
Organization
Kobe University Hospital
Division name
Respiratory Medicine
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL
0783825660
Homepage URL
tnagano@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Kobe University Hospital Clinical Translational Research Center
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
Tel
0783826669
kansatsu@med.kobe-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
| 2022 | Year | 05 | 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
| 2022 | Year | 03 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Peripheral blood is collected before the start of chemo-IO and after 1 week, 6 weeks, and 21 weeks.
Management information
Registered date
| 2022 | Year | 03 | Month | 13 | Day |
Last modified on
| 2022 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053799
| Research Plan | |
|---|---|
| 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 |
