UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037723 |
|---|---|
| Receipt number | R000042994 |
| Scientific Title | A biomarker study of soluble immune markers in stage II-IIIA non-small cell lung cancer (WJOG12319LTR) |
| Date of disclosure of the study information | 2019/08/26 |
| Last modified on | 2022/08/22 09:08:42 |
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Basic information
Public title
A biomarker study of soluble immune markers in stage II-IIIA non-small cell lung cancer (WJOG12319LTR)
Acronym
A soluble immune biomarker study in resectable non-small cell lung cancer (WJOG12319LTR)
Scientific Title
A biomarker study of soluble immune markers in stage II-IIIA non-small cell lung cancer (WJOG12319LTR)
Scientific Title:Acronym
A soluble immune biomarker study in resectable non-small cell lung cancer (WJOG12319LTR)
Region
| Japan |
Condition
Condition
Resectable stage II-IIIA 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 evaluate the soluble immune markers (soluble PD-L1, soluble PD-1, soluble CTLA-4) as biomarkers in resectable NSCLC patients.
Basic objectives2
Others
Basic objectives -Others
Evaluation of biomarkers
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association of soluble immune markers, including soluble PD-L1, soluble PD-1, soluble CTLA-4, and relapse-free survival / overall survival in resectable stage II-IIIA NSCLC
Key secondary outcomes
Association of soluble immune markers, including soluble PD-L1, soluble PD-1, soluble CTLA-4, and clinical background / characteristics
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients enrolled in WJOG4107 study who had available plasma samples
Key exclusion criteria
None
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hidetoshi |
| Middle name | |
| Last name | Hayashi |
Organization
Kindai University, Faculty of Medicine
Division name
Department of Medical Oncology
Zip code
589-8511
Address
377-2, Ohno-higashi, Osaka-Sayama, 589-8511, Japan
TEL
072-366-0221
hidet31@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Nakamura |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
556-0016
Address
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka, JAPAN
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
None
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
Kindai University Hospital
Address
377-2 Ohnohigashi, Osaka-Sayama City, Osaka
Tel
072-366-0221
tanizaki_j@med.kindai.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
| 2019 | Year | 08 | Month | 26 | 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
152
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
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective study to evaluate the association of soluble PD-L1, soluble PD-1, soluble CTLA-4 and clinical background/characteristics and prognosis in reseactable stageII-IIIA NSCLC
Management information
Registered date
| 2019 | Year | 08 | Month | 19 | Day |
Last modified on
| 2022 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042994
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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