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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042005
Receipt No. R000047940
Scientific Title Comprehensive anti-tumor immunity evaluation system for thoracic malignancies using peripheral blood mononuclear cell
Date of disclosure of the study information 2020/10/04
Last modified on 2020/10/04

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Basic information
Public title Comprehensive anti-tumor immunity evaluation system for thoracic malignancies using peripheral blood mononuclear cell
Acronym Comprehensive anti-tumor immunity evaluation system for thoracic malignancies using peripheral blood mononuclear cell
Scientific Title Comprehensive anti-tumor immunity evaluation system for thoracic malignancies using peripheral blood mononuclear cell
Scientific Title:Acronym Comprehensive anti-tumor immunity evaluation system for thoracic malignancies using peripheral blood mononuclear cell
Region
Japan

Condition
Condition thoracic malignancies
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Develop biomarkers to predict the efficacy and prognosis of immune checkpoint inhibitors
Basic objectives2 Others
Basic objectives -Others Develop biomarkers for simple and versatile immune checkpoint inhibitors using peripheral blood
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes results of PBMC analysis
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
99 years-old >
Gender Male and Female
Key inclusion criteria 1. Patients diagnosed with thoracic malignancies (including clinically diagnosed cases)
2. Patients receiving anti-cancer drug treatment or radiation therapy
3. Over 20 years old at the time of consent
4. Patients with written consent to this study
Key exclusion criteria 1. Patients who do not agree to this study in writing
2. Patients judged by the physician to be inappropriate for participation in this study
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name Ou
Middle name
Last name Yamaguchi
Organization Saitama Medical University International Medical Center
Division name respiratory medicine
Zip code 350-1298
Address 1397-1, Yamane, Hidaka City, Japan
TEL 042-984-4111
Email ouyamagu@saitama-med.ac.jp

Public contact
Name of contact person
1st name Ou
Middle name
Last name Yamaguchi
Organization Saitama Medical University International Medical Center
Division name respiratory medicine
Zip code 350-1298
Address 1397-1, Yamane, Hidaka City, Japan
TEL 042-984-4111
Homepage URL
Email ouyamagu@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University International Medical Center
Institute
Department

Funding Source
Organization Saitama Medical University International Medical 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 Saitama Medical University International Medical Center
Address 1397-1, Yamane, Hidaka City, Japan
Tel 042-984-4523
Email chikens@saitama-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

Other administrative information
Date of disclosure of the study information
2020 Year 10 Month 04 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 Enrolling by invitation
Date of protocol fixation
2020 Year 07 Month 09 Day
Date of IRB
2020 Year 09 Month 02 Day
Anticipated trial start date
2020 Year 10 Month 05 Day
Last follow-up date
2035 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In addition to PBMC blood sampling, serum, whole blood, and tissues are stored.

Management information
Registered date
2020 Year 10 Month 04 Day
Last modified on
2020 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047940

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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