UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061244 |
|---|---|
| Receipt number | R000070075 |
| Scientific Title | An ancillary biomarker exploratory study using AI-based CT and PET/CT image analysis for prediction of treatment response and prognosis in patients with resectable discrete N2 stage IIIA-B non-small cell lung cancer enrolled in the WJOG12119L/SQUAT trial (WJOG12119LTR3) |
| Date of disclosure of the study information | 2026/04/14 |
| Last modified on | 2026/04/13 10:39:23 |
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Basic information
Public title
Biomarker Study Using AI-based Image Analysis in Induction Chemo-radiation Therapy Followed by Surgery with Perioperative Immunotherapy for Resectable Stage Discrete N2 IIIA-B Non-small Cell Lung Cancer (SQUAT-TR3 Study) (WJOG12119LTR3)
Acronym
WJOG12119LTR3 / SQUAT-TR3 Study
Scientific Title
An ancillary biomarker exploratory study using AI-based CT and PET/CT image analysis for prediction of treatment response and prognosis in patients with resectable discrete N2 stage IIIA-B non-small cell lung cancer enrolled in the WJOG12119L/SQUAT trial (WJOG12119LTR3)
Scientific Title:Acronym
WJOG12119LTR3 / SQUAT-TR3 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 perform a comprehensive analysis using an artificial intelligence-based imaging system (Plus.Lung.Nodule, Plusman Inc.) to predict the treatment response to the investigational therapy of the WJOG12119L/SQUAT trial-namely, induction chemoradiotherapy combined with preoperative and postoperative immunotherapy-by utilizing previously acquired imaging data from patients enrolled in the Phase II trial entitled "A Phase II study of quadruple-modality therapy consisting of induction chemoradiotherapy with perioperative immunotherapy for resectable discrete N2 stage IIIA-B non-small cell lung cancer" (WJOG12119L/SQUAT trial).
Basic objectives2
Others
Basic objectives -Others
Exploration of AI-based imaging biomarkers for prediction of treatment response and prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between AI-based imaging prediction of treatment response and pathological response (MPR/pCR)
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
30
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Soh |
Organization
Osaka Metropolitan University, Graduate School of Medicine
Division name
Department of Thoracic Surgery
Zip code
545-0051
Address
1-4-3 Asahimachi, Abeno-ku, Osaka 545-0051, Japan
TEL
06-6645-3611
f24185y@omu.ac.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
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
Clinical Research and Innovation Center, Clinical Trial Office, Osaka Metropolitan University Hospital
Address
1-5-7 Asahimachi, Abeno-ku, Osaka, Japan
Tel
06-6645-3447
med-shinki@ml.omu.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
| 2026 | Year | 04 | Month | 14 | 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
| 2026 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2026 | Year | 04 | Month | 13 | Day |
Last modified on
| 2026 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070075
