UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024623 |
|---|---|
| Receipt number | R000028329 |
| Scientific Title | Examining immune-related molecules for the discovery of potential therapeutic targets in non-small cell lung cancers through the analysis of fresh peripheral blood and/or pleural effusion from patients treated with anti-PD-1 antibodies. |
| Date of disclosure of the study information | 2016/10/31 |
| Last modified on | 2020/10/17 14:11:21 |
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Basic information
Public title
Examining immune-related molecules for the discovery of potential therapeutic targets in non-small cell lung cancers through the analysis of fresh peripheral blood and/or pleural effusion from patients treated with anti-PD-1 antibodies.
Acronym
Immune-profiling of fresh peripheral blood and/or pleural effusion from non-small cell lung cancer patients treated with anti-PD-1 antibodies.
Scientific Title
Examining immune-related molecules for the discovery of potential therapeutic targets in non-small cell lung cancers through the analysis of fresh peripheral blood and/or pleural effusion from patients treated with anti-PD-1 antibodies.
Scientific Title:Acronym
Immune-profiling of fresh peripheral blood and/or pleural effusion from non-small cell lung cancer patients treated with anti-PD-1 antibodies.
Region
| Japan |
Condition
Condition
Previously treated patients with non-small cell lung cancer
Classification by specialty
| Medicine in general | Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To reveal the immune-related molecules involved in the efficiency of anti PD-1 antibodies based on the analysis of fresh peripheral blood and/or pleural effusion.
Basic objectives2
Others
Basic objectives -Others
response rate, progression free survival, overall survival
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Immune-profiling of fresh peripheral blood and/or pleural effusion at three time points: pretreatment, post 1st dose, post 2nd dose
Key secondary outcomes
Continue to collect blood and/or pleural effusion monthly for analyzing immune profile after discontinuation of anti PD-1 antibody 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Pathologically confirmed non-small-cell lung cancer
2)Stage VI or recurrent diseases (without any indications for operation and radiotherapy) with peripheral blood and/or pleural effusion that can be taken
3)Have measurable lesion in lung by using the RECIST ver1.1 (Response Evaluation Criteria In Solid Tumors) criteria.
4)Twenty or more years old at the time of informed consent
5)Eastern Cooperative Oncology Group Performance Status (ECOG PS)0-2
6)Have adequate organ function within 14 days before entry
7)Estimate life expectancy of at least 12 weeks
8)Have signed an informed consent document
Key exclusion criteria
1)With interstitial pneumonia or pulmonary fibrosis on a chest X-ray
2)Clinically significant drug allergy
3)Presence of other active malignancy
4)With pericardial effusion, pleural effusion and ascites in need of treatment of drainage
5)Positive serum HBs antigen
6)With severe infection, cardiac diseases, diabetes, hypertension, other severe complication
7)Patients received palliative radiotherapy for brain metastases and bone metastases, except for the primary lesion within 2weeks.
8)Pregnancy or lactating patients
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Kumanogoh |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Respiratory Medicine, Allergy and Rheumatic Diseases
Zip code
565-0871
Address
2-2 Yamada-oka, Suita, Osaka, 565-0871
TEL
06-6879-3833
kumanogo@imed3.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Shohei |
| Middle name | |
| Last name | Koyama |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Respiratory Medicine, Allergy and Rheumatic Diseases
Zip code
565-0871
Address
2-2 Yamada-oka, Suita, Osaka, 565-0871
TEL
06-6879-3833
Homepage URL
koyama@imed3.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
KAKENHI and Funding from non profit foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Internal Medicine,
Toneyama National Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Center for Translational Research Osaka University Hospital
Address
2-2 Yamada-oka, Suita, Osaka, 565-0871
Tel
0662108290
shiken@hp-crc.med.osaka-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
| 2016 | Year | 10 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Prospective immune-profiling using fresh whole blood still on going.
In follow-up study after discontinuation of anti-PD-1 treatment, we monitored anti PD-1 antibody binding and immune profiling in T cells until complete loss of residual therapeutic antibody binding. We reported the partial results at IASLC meeting 2017(https://www.sciencedirect.com/science/article/pii/S1556086417329428). We completed the recruitment for the follow-up study May 2017.
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
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
In this study, we collect patient samples before and after anti PD-1 antibody treatment and immunologically analyze them without freezing.
Management information
Registered date
| 2016 | Year | 10 | Month | 29 | Day |
Last modified on
| 2020 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028329
