UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062925 |
|---|---|
| Receipt number | R000072042 |
| Scientific Title | The observational study to evaluate the diagnostic value of Next generation sequencer (NGS) and PCR method for detecting driver oncogene and clinical course |
| Date of disclosure of the study information | 2026/09/14 |
| Last modified on | 2026/09/14 22:54:52 |
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Basic information
Public title
The observational study to evaluate the diagnostic value of Next generation sequencer (NGS) and PCR method for detecting driver oncogene and clinical course
Acronym
NGS-PCR NSCLC Study
Scientific Title
The observational study to evaluate the diagnostic value of Next generation sequencer (NGS) and PCR method for detecting driver oncogene and clinical course
Scientific Title:Acronym
NGS-PCR NSCLC Study
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The objective of this prospective observational study is to evaluate the concordance of driver oncogene alterations detected by next-generation sequencing (NGS), primarily Oncomine, and PCR-based testing, primarily AmoyDx, in patients with non-small cell lung cancer, and to evaluate treatment outcomes and clinical courses according to the results of these molecular tests.
Factors potentially affecting test results and subgroup analyses according to patient characteristics and genomic alterations will also be explored.
As an ancillary exploratory analysis, prospectively collected plasma samples analyzed using the Oncomine Precision Assay (OPA) will be used to evaluate the frequency of TP53 mutations, TP53 variant subtypes, and their associations with prior treatment exposure and survival outcomes.
Basic objectives2
Others
Basic objectives -Others
1 Concordance between NGS and PCR-based testing (AmoyDx) for individual genomic alterations.
2 Objective response rate and tumor shrinkage with molecular targeted therapy according to genomic test results.
3 Progression-free survival with molecular targeted therapy according to genomic test results.
Ancillary exploratory analysis: The frequency of TP53 mutations detected by OPA will be evaluated using prospectively collected plasma samples. TP53 mutations will also be classified as disruptive or non-disruptive, and exploratory analyses will evaluate their associations with EGFR mutation status, prior treatment exposure, prior osimertinib treatment, and overall survival.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concordance rate between NGS and PCR-based testing (AmoyDx) for driver oncogene alterations that are actionable with molecular targeted therapy at the time of testing.
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
1. Patients with a pathologically confirmed diagnosis of non-small cell lung cancer.
2. Patients who provide consent to undergo genomic testing, or patients who have previously undergone genomic testing using NGS or AmoyDx and provide consent for participation in the study.
Key exclusion criteria
1. Patients from whom informed consent for study participation cannot be obtained.
2. Patients considered inappropriate for participation by the investigators.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Ito |
Organization
Saiseikai Matsusaka Municipal Hospital
Division name
Respiratory Center
Zip code
5150073
Address
1550, Tonomachi, Matsusaka city, Mie, 515-0073, Japan
TEL
0598231515
kentarou_i_0214@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Ito |
Organization
Saiszeikai Matsusaka Municipal Hospital
Division name
Respiratory Center
Zip code
5150073
Address
1550, Tonomachi
TEL
0598231515
Homepage URL
kentarou_i_0214@yahoo.co.jp
Sponsor or person
Institute
Saiseikai Matsusaka Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Saiseikai Matsusaka Municipal Hospital
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
Saiseikai Matsusaka Municipal Hospital
Address
1550, Tonomachi, Matsusaka, Mie
Tel
0598231515
kentarou_i_0214@yahoo.co.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 | 09 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-institution prospective observational study of patients with non-small cell lung cancer, with no treatment intervention assigned for research purposes. Genomic testing results obtained using NGS, primarily Oncomine, and PCR-based testing, primarily AmoyDx, together with clinical outcomes, are collected.The primary outcome is the concordance between the two testing methods for driver oncogene alterations that are actionable with molecular targeted therapies.
As an ancillary exploratory analysis, TP53 alterations are evaluated using plasma samples and clinical information prospectively collected within the parent observational study. The analysis evaluates the frequency of TP53 mutations detected using the Oncomine Precision Assay (OPA), TP53 variant subtypes including disruptive and non-disruptive mutations, and their associations with EGFR mutation status, prior treatment exposure, prior osimertinib treatment, and overall survival. The TP53 analysis is not the primary endpoint of the parent study and is considered an ancillary exploratory analysis using prospectively collected samples and clinical data.
This UMIN-CTR registration is being performed after initiation of the study. The samples and clinical information used for the prospective analyses were collected according to the study protocol.
Management information
Registered date
| 2026 | Year | 09 | Month | 14 | Day |
Last modified on
| 2026 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072042
