UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000058336 |
|---|---|
| Receipt number | R000066687 |
| Scientific Title | Biomarker Study with Spatial Transcriptome, Tumor Immune Microenvironment and Microbiome Analysis in Induction Chemo-radiation Therapy Followed by Surgery with Perioperative Immunotherapy for Resectable Stage Discreate N2 IIIA-B Non-small Cell Lung Cancer (SQUAT-TR1 Study) (WJOG12119LTR1) |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/07/01 17:50:04 |
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Basic information
Public title
Biomarker Study with Spatial Transcriptome, Tumor Immune Microenvironment and Microbiome Analysis in Induction Chemo-radiation Therapy Followed by Surgery with Perioperative Immunotherapy for Resectable Stage Discreate N2 IIIA-B Non-small Cell Lung Cancer
(SQUAT-TR1 Study) (WJOG12119LTR1)
Acronym
WJOG12119LTR1: SQUAT-TR1 study
Scientific Title
Biomarker Study with Spatial Transcriptome, Tumor Immune Microenvironment and Microbiome Analysis in Induction Chemo-radiation Therapy Followed by Surgery with Perioperative Immunotherapy for Resectable Stage Discreate N2 IIIA-B Non-small Cell Lung Cancer
(SQUAT-TR1 Study) (WJOG12119LTR1)
Scientific Title:Acronym
WJOG12119LTR1: SQUAT-TR1 study
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to identify predictive biomarkers of therapeutic response to the quadruple-modality regimen - induction chemoradiotherapy plus pre- and postoperative immunotherapy - evaluated in ' WJOG12119L, a Phase II trial assessing the efficacy and safety of this approach in patients with resectable discrete N2 stage IIIA - B non-small-cell lung cancer.' The analysis will use tissue specimens previously obtained from participants enrolled in WJOG12119L.
Basic objectives2
Others
Basic objectives -Others
Association between the major pathological response (MPR) rate and biomarkers identified through tumor microenvironment and microbiome analyses
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between the major pathological response (MPR) rate and biomarkers identified through tumor microenvironment and microbiome analyses
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were enrolled in WJOG12119L and, at the time of enrollment in the present study, had not withdrawn their informed consent for that trial.
Key exclusion criteria
Patients deemed inappropriate for inclusion by the attending physician.
Target sample size
31
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Tsuboi |
Organization
National Cancer Center Hospital East
Division name
Department of Thoracic Surgery
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
mtsuboi@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Ishizuka |
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 556-0016 JAPAN
TEL
06-6633-7400
Homepage URL
https://www.wjog.jp/
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.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
| 2025 | Year | 07 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aims to identify biomarkers that predict the therapeutic efficacy of the WJOG12119L investigational regimen - induction chemoradiotherapy combined with pre- and postoperative immunotherapy - by analyzing tissue specimens already collected from patients enrolled in WJOG12119L.
Management information
Registered date
| 2025 | Year | 07 | Month | 01 | Day |
Last modified on
| 2025 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066687
