UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063197 |
|---|---|
| Receipt number | R000072335 |
| Scientific Title | Prevalence and Clinical Characteristics of KRAS Mutations in Patients with Non-Small Cell Lung Cancer Undergoing Multiplex Genetic Testing in Northern Hokkaido: A Multicenter Retrospective Study |
| Date of disclosure of the study information | 2026/10/07 |
| Last modified on | 2026/10/07 00:57:59 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prevalence and Clinical Characteristics of KRAS Mutations in Non-Small Cell Lung Cancer in Northern Hokkaido
Acronym
Prevalence and Clinical Characteristics of KRAS Mutations in Non-Small Cell Lung Cancer in Northern Hokkaido
Scientific Title
Prevalence and Clinical Characteristics of KRAS Mutations in Patients with Non-Small Cell Lung Cancer Undergoing Multiplex Genetic Testing in Northern Hokkaido: A Multicenter Retrospective Study
Scientific Title:Acronym
Prevalence and Clinical Characteristics of KRAS Mutations in Patients with Non-Small Cell Lung Cancer Undergoing Multiplex Genetic Testing in Northern Hokkaido: A Multicenter Retrospective Study
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This multicenter retrospective observational study aims to determine the prevalence, subtype distribution, clinical characteristics, and prognosis of KRAS-mutant non-small cell lung cancer among patients residing in Northern Hokkaido who underwent multiplex genetic testing in routine clinical practice. The findings will also be exploratively compared with previously reported Japanese and international data to investigate potential regional differences in the distribution of KRAS mutations.
Basic objectives2
Others
Basic objectives -Others
Retrospective observational study of the prevalence and clinical characteristics of KRAS mutations
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The prevalence of KRAS mutations among patients with non-small cell lung cancer residing in the predefined Northern Hokkaido area at the time of multiplex genetic testing and evaluable for KRAS mutation status.
Key secondary outcomes
Distribution of KRAS mutation subtypes among KRAS-mutant cases.
Proportion of KRAS G12C among KRAS-mutant cases.
Distribution of KRAS mutations according to nucleotide substitution type.
Association between transversion-type KRAS mutations and individual smoking exposure.
Absolute prevalence of KRAS G12C mutations in the entire study population.
Clinical characteristics and prognosis of patients with KRAS-mutant non-small cell lung cancer.
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
Patients with pathologically confirmed non-small cell lung cancer (NSCLC).
Patients who underwent multiplex genetic testing at Asahikawa Medical University Hospital or one of the participating institutions between January 1, 2023 and December 31, 2025.
Patients aged 20 years or older at the time of multiplex genetic testing.
Key exclusion criteria
Patients who declined participation in the study, either personally or through an appropriate representative.
Patients considered unsuitable for inclusion in the study by the principal investigator or study investigators.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Takaaki |
| Middle name | |
| Last name | Sasaki |
Organization
Asahikawa Medical University
Division name
Department of Respiratory Medicine and Neurology
Zip code
078-8510
Address
2-1-1-1 Midorigaoka Higashi, Asahikawa, Hokkaido, Japan
TEL
0166-69-3290
takaaki6@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Ryotaro |
| Middle name | |
| Last name | Kida |
Organization
Asahikawa Medical University
Division name
Department of Respiratory Medicine and Neurology
Zip code
0166-69-3290
Address
2-1-1-1 Midorigaoka Higashi, Asahikawa, Hokkaido, Japan
TEL
0166-69-3290
Homepage URL
rkida@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Asahikawa Medical University Research Ethics Committee
Address
2-1-1-1 Midorigaoka Higashi, Asahikawa, Hokkaido, Japan
Tel
0166-68-2297
rs-kp.g@asahikawa-med.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 | 10 | Month | 07 | 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 | 07 | Month | 31 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter retrospective observational study. Eligible patients with non-small cell lung cancer who underwent multiplex genetic testing in routine clinical practice at participating institutions between January 1, 2023 and December 31, 2025 will be comprehensively identified. The primary analysis population will consist of patients residing in the predefined Northern Hokkaido area at the time of multiplex genetic testing. The prevalence, subtype distribution, and nucleotide substitution patterns of KRAS mutations will be evaluated, together with their associations with smoking exposure, occupational history, patient characteristics, and testing methods. Prognostic outcomes according to KRAS mutation status and other major driver alterations will also be explored among patients with unresectable advanced or recurrent disease.
Management information
Registered date
| 2026 | Year | 10 | Month | 07 | Day |
Last modified on
| 2026 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072335
