UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058881 |
|---|---|
| Receipt number | R000067253 |
| Scientific Title | uardant360 CDx Observational Study for Hidden Oncogenes in advanced non-squamous NSCLC patients without detected driver mutations at diagnosis |
| Date of disclosure of the study information | 2025/08/25 |
| Last modified on | 2025/08/25 07:40:45 |
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Basic information
Public title
Guardant360 CDx Observational Study for Hidden Oncogenes in advanced non-squamous NSCLC patients without detected driver mutations at diagnosis
Acronym
GOSHO study
Scientific Title
uardant360 CDx Observational Study for Hidden Oncogenes in advanced non-squamous NSCLC patients without detected driver mutations at diagnosis
Scientific Title:Acronym
GOSHO study
Region
| Japan |
Condition
Condition
Patients with advanced non-squamous non-small cell lung cancer in whom driver oncogenes were not detected using testing at the diagnosis
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The primary objective of this study is to clarify the proportion of newly detected driver oncogenes using the Guardant360 CDx under health insurance coverage in patients with advanced non-squamous non-small cell lung cancer who did not driver oncogenes detected using testing at the diagnosis and who have received drug therapy up to the second line.
Basic objectives2
Others
Basic objectives -Others
We will evaluate the clinical usefulness of the Guardant360 CDx test, including the administration rate of molecular targeted drugs based on newly detected driver gene alterations and the test success rate.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of newly detected driver oncogenes using Guardant360 CDx. Driver oncogenes are defined as EGFR mutations, ALK fusions, ROS1 fusions, BRAF V600E, MET exon 14 skipping mutations, RET fusions, KRAS G12C mutations, HER2 mutations, and NTRK fusions. These driver gene aberrations are classified as evidence level 1 by OncoKB.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients have been diagnosed with non-squamous non-small cell lung cancer by histopathological or cytological examination.
2) No driver gene abnormalities are detected by genetic diagnostic methods at the time of diagnosis. Driver gene abnormalities are defined as EGFR gene mutations, ALK fusion genes, ROS1 fusion genes, BRAF V600E, MET exon 14 skipping mutations, RET fusion genes, KRAS G12C mutations, HER2 gene mutations, and NTRK fusions. Patients will be ineligible if the genetic testing used at the time of diagnosis determines that the submitted specimen is unanalyzable or of poor quality (e.g., insufficient specimen volume, nucleic acid degradation, contamination, etc.).
3) Patients have received up to two standard drug therapies. Patients may or may not have received a prior immune checkpoint inhibitor. Postoperative adjuvant therapy does not count as prior treatment.
4) Patients are scheduled for evaluation using Guardant360 CDx.
5) Patients aged 20 years or older.
6) The contents of the study have been fully explained to the patient prior to enrollment in this clinical study, and written consent has been obtained from the patient.
Key exclusion criteria
1) Patients who have already undergone a cancer gene panel test other than Guardant360 CDx.
2) Patients who were unable to provide written consent.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Tadaaki |
| Middle name | |
| Last name | Yamada |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Pulmonary Medicine
Zip code
6028566
Address
465, Kajii-cho, Kamigyo-ku, Kyoto
TEL
0752515513
tayamada@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Ishida |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Pulmonary Medicine
Zip code
602-8054
Address
465, Kajii-cho, Kamigyo-ku, Kyoto
TEL
0752515513
Homepage URL
mishida@koto.kpu-m.ac.jp
Sponsor or person
Institute
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Guardant Health Japan Corp.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Address
465, Kajii-cho, Kamigyo-ku, Kyoto
Tel
0752515513
mishida@koto.kpu-m.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
Select
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 25 | 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 | 08 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2028 | 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 prospective observational study of patients with advanced non-squamous non-small cell lung cancer in whom driver oncogenes were not detected at diagnosis.
Management information
Registered date
| 2025 | Year | 08 | Month | 25 | Day |
Last modified on
| 2025 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067253
