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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030284
Receipt No. 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 2020/06/08

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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

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
Email 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
Email yonakamu@tochigi-cc.jp

Sponsor
Institute Tochigi Cancer Center
Institute
Department

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
Email 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
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 Open public 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
2020 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034586

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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