UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058423 |
|---|---|
| Receipt number | R000066442 |
| Scientific Title | A study to investigate the actual status of multiplex genetic testing for non-small cell lung cancer. TORG2543 |
| Date of disclosure of the study information | 2025/07/10 |
| Last modified on | 2025/07/10 16:53:32 |
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Basic information
Public title
A study to investigate the actual status of multiplex genetic testing for non-small cell lung cancer. TORG2543
Acronym
TORG2543 (TORG BANK Project)
Scientific Title
A study to investigate the actual status of multiplex genetic testing for non-small cell lung cancer. TORG2543
Scientific Title:Acronym
A study to investigate the actual status of multiplex genetic testing for non-small cell lung cancer. TORG2543
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate the real-world status of multiplex genetic testing in patients with advanced or recurrent non-small cell lung cancer. This includes collecting data on the frequency of positive gene mutations/translocations, the clinical backgrounds of mutation-positive patients, the use and effectiveness of various targeted therapies, and treatment outcomes. Additionally, we aim to compare the positivity rates across different multiplex assays and assess the frequency of newly detected actionable mutations/translocations by CGP (cancer genome profiling) testing in patients who had previously undergone multiplex testing at the start of treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall positivity rate of gene mutations/translocations identified by multiplex genetic
Key secondary outcomes
Positivity rate of gene mutations/translocations for each multiplex assay
Proportion of patients receiving molecular targeted therapy and corresponding treatment efficacy (ORR, TTD, PFS, OS) for each gene mutation/translocation
Treatment efficacy of non-targeted therapies for each gene mutation/translocation (ORR, TTD, PFS, OS)
Proportion of cases with newly identified gene mutations/translocations among patients who underwent CGP testing
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. Pathologically confirmed diagnosis of non-small cell lung cancer.
2. Unresectable and not amenable to definitive radiotherapy Stage III disease, Stage IV disease, or postoperative recurrence.
3. Age >= 20 years at the time when the results of insurance-covered multiplex genetic testing became available.
4. Patients must have undergone one of the specified multiplex gene tests under insurance coverage before the initiation of first-line therapy for advanced or recurrent disease between January 1, 2021 and December 31, 2024. Patients receiving best supportive care or those who have not yet started treatment at the time of enrollment are also eligible.
- Oncomine Dx Target Test Multi-CDx System (ODxTT)
- AmoyDx Lung Cancer Multi-Gene PCR Panel (Amoy)
- Lung Cancer Compact Panel Dx Multi-Companion Diagnostic System (CP)
5. Patient information can be collected from medical records.
Key exclusion criteria
Patients who refused to participate in this study by opting out
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Mizugaki |
Organization
National Hospital Organization Hokkaido Cancer Center
Division name
Respiratory Medicine
Zip code
003-0804
Address
4-2-3-54 Kikusui, Shiroishi-ku, Sapporo, Hokkaido
TEL
011-811-9111
hidenori.mizugaki@ifcr.or.jp
Public contact
Name of contact person
| 1st name | Motoki |
| Middle name | |
| Last name | Sekikawa |
Organization
Teine Keijinkai Hospital
Division name
Respiratory Medicine
Zip code
006-0811
Address
1-1-40, Maeda 1jo 12-chome, Teine-ku, Sapporo, Hokkaido
TEL
011-681-8111
Homepage URL
sekikawa_motoki@yahoo.co.jp
Sponsor or person
Institute
National Hospital Organization Hokkaido Cancer Center
Institute
Department
Personal name
Hidenori Mizugaki
Funding Source
Organization
AstraZeneca K.K.
Nippon Boehringer Ingelheim Co., Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Thoracic Oncology Research Group
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, National Hospital Organization Hokkaido Cancer Center
Address
2-3-54, Kikusui 4jo 2-chome, Shiroishi-ku, Sapporo
Tel
011-811-9111
100-mb10kar1@mail.hosp.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 | 10 | 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
| 2025 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a multicenter retrospective observational study.
Management information
Registered date
| 2025 | Year | 07 | Month | 10 | Day |
Last modified on
| 2025 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066442
