UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030284 |
|---|---|
| Receipt number | R000034586 |
| Scientific Title | Search for predicvite factors of anti-PD-1 antibody, pembrolizumab |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2023/06/12 08:56:01 |
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Basic information
Public title
Search for predicvite factors of anti-PD-1 antibody, pembrolizumab
Acronym
Search for predicvite factors of anti-PD-1 antibody, pembrolizumab
Scientific Title
Search for predicvite factors of anti-PD-1 antibody, pembrolizumab
Scientific Title:Acronym
Search for predicvite factors of anti-PD-1 antibody, pembrolizumab
Region
| Japan |
Condition
Condition
advanced non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
As a predictive factor for the effect of penbrolizumab, evaluate whether measurement of gelsolin immunocomplex is useful or not. We also analyze the distribution of immune complexes in the serum of patients with advanced NSCLC treated with pembrolizumab and evaluate the correlation with the effects of it.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection of gelsolin immunocomplex
Key secondary outcomes
1) Response rate of pembrolizumab
2) Detection rate of Gelsolin immune complex
3) Progression free survival (PFS) of pembrolizumab
4) Number of immune complexes in serum of pembrolizumab administration cases
5) Number of Gelsolin immune complexes in serum of pembrolizumab administration cases
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)Advanced non-small cell lung cancer who is treated with penbrolizumab, having measurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) Ver 1.1
2)Aged 20 years or older at consent time.
3)With written informed consent.
Key exclusion criteria
1)Positive HBS-ag and/or HCV-ab
2)Positive HIV-ab
3)the primary doctor judging inappropriate for entry
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoichi |
| Middle name | |
| Last name | Nakamura |
Organization
Tochigi Cancer Center
Division name
Department of Medical Oncology, Division of Thoracic Oncology
Zip code
320-0834
Address
4-9-13 Yohnan, Utstnomiya
TEL
0286585151
yonakamu@tochigi-cc.jp
Public contact
Name of contact person
| 1st name | Yoichi |
| Middle name | |
| Last name | Nakamura |
Organization
Tochigi Cancer Center
Division name
Department of Medical Oncology, Division of Thoracic Oncology
Zip code
320-0834
Address
4-9-13 Yohnan, Utstnomiya
TEL
0286585151
Homepage URL
yonakamu@tochigi-cc.jp
Sponsor or person
Institute
Tochigi Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Tochigi Cancer Center
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
Institutional review board, Tochigi Cancer Cente
Address
4-9-13 Yohnan, Utstnomiya
Tel
0286585151
kenkyu@tochigi-cc.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
茨城県立中央病院呼吸器内科、群馬県立がんセンター呼吸器内科
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | 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
110
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Purpose
As a predictive factor for the effect of penbrolizumab, evaluate whether measurement of gelsolin immunocomplex in serum is useful or not. We also analyze the distribution of immune complexes in serum of patients with advanced NSCLC treated with pembrolizumab and evaluate the correlation with the effects of it.
Patients
1)advanced non-small cell lung cancer who is treated with penbrolizumab, having measurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) Ver 1.1
2)Aged 20 years or older at consent time.
3)With written informed consent.
Method
We detect the gelsolin immunocomplex and other immune complexes in serum of patients with advanced NSCLC treated with pembrolizumab using immune complexome method. We also evaluate the correlation with the effects of pembrolizumab and the results of immune complexome analysis.
Management information
Registered date
| 2017 | Year | 12 | Month | 06 | Day |
Last modified on
| 2023 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034586
