UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062605 |
|---|---|
| Receipt number | R000071653 |
| Scientific Title | Concordance analysis between HER2 immunohistochemistry and next generation sequencer in non-small lung cancer |
| Date of disclosure of the study information | 2026/08/19 |
| Last modified on | 2026/08/19 08:58:45 |
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Basic information
Public title
Concordance analysis between HER2 immunohistochemistry and next generation sequencer in non-small lung cancer
Acronym
Concordance analysis between HER2 immunohistochemistry and next generation sequencer in non-small lung cancer
Scientific Title
Concordance analysis between HER2 immunohistochemistry and next generation sequencer in non-small lung cancer
Scientific Title:Acronym
Concordance analysis between HER2 immunohistochemistry and next generation sequencer in non-small lung cancer
Region
| Japan |
Condition
Condition
non-small lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To establish a HER2 screening system, we analysis HER2 overexpression by IHC in HER2 amplified NSCLC.
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concordance between HER2 overexpression detected HER2 IHC and HER2 amplification analysed NGS test
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Recurrent or progressive non small lung cancer
18years of age or older at the time of obtaining informed consent for the study or at the time of opting out
Confirmed HER2 amplification status by Foundation One
Driver mutation is not required
Systematic chemotherapy history is not required
The specimens submitted to Foundation One are stored, and we can provide additional unstained slides as needed for IHC and FISH testing
Key exclusion criteria
Not applicable.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Takahama |
Organization
Kindai University faculty of medicine
Division name
Department of Medical Oncology
Zip code
590-0197
Address
1-14-1 Miharadai,Minamiku,Saka, Osaka,
TEL
072-288-7222
takahama_t@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Waka |
| Middle name | |
| Last name | Dohi |
Organization
Kindai University faculty of medicine
Division name
Department of Medical Oncology
Zip code
590-0197
Address
1-14-1 Miharadai,Minamiku,Saka, Osaka,
TEL
072-288-7222
Homepage URL
240503@med.kindai.ac.jp
Sponsor or person
Institute
not applicable
Institute
Department
Personal name
Funding Source
Organization
not applicable
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
Ethics Committee of the Kinki University School of Medicine
Address
1-14-1 Miharadai,Minamiku,Saka, Osaka,
Tel
072-288-7222
komc.crb@med.kindai.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 | 08 | Month | 19 | 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 | 30 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 19 | 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
Enroll eligible patients at the collaborative research facility.
Management information
Registered date
| 2026 | Year | 08 | Month | 18 | Day |
Last modified on
| 2026 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071653
