UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026140 |
|---|---|
| Receipt number | R000030042 |
| Scientific Title | Immune monitoring in patients with NSCLC receiving immune checkpoint inhibitors |
| Date of disclosure of the study information | 2017/02/15 |
| Last modified on | 2023/02/20 11:24:53 |
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Basic information
Public title
Immune monitoring in patients with NSCLC receiving immune checkpoint inhibitors
Acronym
Immune monitoring in patients with NSCLC receiving immune checkpoint inhibitors
Scientific Title
Immune monitoring in patients with NSCLC receiving immune checkpoint inhibitors
Scientific Title:Acronym
Immune monitoring in patients with NSCLC receiving immune checkpoint inhibitors
Region
| Japan |
Condition
Condition
non-small-cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the influence of immune checkpoints inhibitors to immune system and its association with efficacy and safety.
Basic objectives2
Others
Basic objectives -Others
To investigate the changes in tumor-spesific antibodies.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in proportion of immune cells in 2, 4, and 8 weeks after immune checkpoints therapy.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Pathologically diagnosed non-small-cell lung cancer.
Patients receiving immune checkpoints therapy.
Inoperable advanced or recurrent non-small-cell lung cancer patients.
Expected prognosis >3months.
Aged 20 years or more.
Informed consent was given.
Key exclusion criteria
Patients with current or history of autoimmune disease.
Patients with interstitial lung disease.
Patients receiving steroids or immune suppressive therapy.
Inappropriate patients decided by attending physician.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Suda |
Organization
Hamamatsu University School of Medicine
Division name
Second Devision, department of internal medicine
Zip code
4313192
Address
1-20-1 Handayama, Hamamatsu, Japan
TEL
053-435-2263
suda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Karayama |
Organization
Hamamatsu University School of Medicine
Division name
Department of Clinical Oncology
Zip code
4313192
Address
1-20-1 Handayama, Hamamatsu, Japan
TEL
053-435-2419
Homepage URL
karayama@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
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
National Cancer Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board
Address
Handayama 1-20-1 Hamamatsu
Tel
0534352111
rinri@hama-med.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
浜松医科大学病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 15 | Day |
Related information
URL releasing protocol
no applicable
Publication of results
Published
Result
URL related to results and publications
https://www.globalhealthmedicine.com/site/article.html?doi=10.35772/ghm.2022.01052
Number of participants that the trial has enrolled
20
Results
Higher levels of CD86+pDCs at the baseline and a reduction in those levels 2 and 8 weeks after ICIs were associated with the occurrence of irAEs. Higher levels of NK cells were associated with an objective response to ICIs.
Results date posted
| 2023 | Year | 02 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients were included in this study if they presented with inoperable stage IIIB or IV NSCLC, had an Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0-2, and were scheduled for anti-PD-1 therapy. Patients who had a history of ICI therapy were excluded. The choice of anti-PD-1 therapy depended on the treating physician, and therapy was administered intravenously as follows: nivolumab at a dose of 3 mg/ kg every 2 weeks or pembrolizumab at a dose of 200 mg every 3 weeks.
Participant flow
This was an exploratory, prospective observational study conducted in accordance with the ethical standards of the Declaration of Helsinki. The study protocol was approved by the Institutional Review Board of the Hamamatsu University School of Medicine (No. 16- 080). Each patient provided written informed consent. The study was registered with the University Hospital Medical Information Network Clinical Trial Registry (000026140).
Adverse events
The occurrence of irAEs was observed in 6 patients (37.5%) (Table 2). The median time to an irAE was 44 days (range: 7-133 days).
Outcome measures
Association between PBMC and irEs.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 02 | Month | 15 | Day |
Last modified on
| 2023 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030042
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| Registered date | File name |
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