UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057400 |
|---|---|
| Receipt number | R000065516 |
| Scientific Title | Performance Evaluation of ALK IHC Testing in the Detection of ALK in Non-Small Cell Lung Cancer |
| Date of disclosure of the study information | 2025/03/26 |
| Last modified on | 2025/10/23 10:01:12 |
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Basic information
Public title
Performance Evaluation of ALK IHC Testing in the Detection of ALK in Non-Small Cell Lung Cancer
Acronym
Performance Evaluation of ALK IHC Testing in the Detection of ALK in NSCLC
Scientific Title
Performance Evaluation of ALK IHC Testing in the Detection of ALK in Non-Small Cell Lung Cancer
Scientific Title:Acronym
Performance Evaluation of ALK IHC Testing in the Detection of ALK in NSCLC
Region
| Japan |
Condition
Condition
Non small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the performance of ALK testing using immunohistochemical staining methods.
Basic objectives2
Others
Basic objectives -Others
effectiveness of the test
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Detection rate of ALK mutations by ALK IHC testing in cases negative for all driver gene mutations in multiplex testing.
Key secondary outcomes
The concordance rate of ALK mutations between ALK IHC testing and CGP testing in cases negative for all driver gene mutations in multiplex testing.
Confirmation of the ALK mutation positivity rate during the target period.
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
NSCLC cases diagnosed from January 1, 2019, to June 30, 2024 at each participating medical institution.
Key exclusion criteria
Patients who is judged as not suitable in this study
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Hatanaka |
Organization
Hokkaido University Hospital
Division name
Center for Development of Advanced Diagnostics
Zip code
0608468
Address
N14W5, Kita-ku, Sapporo
TEL
011-706-7933
yhatanaka@huhp.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Asami |
| Middle name | |
| Last name | Okumura |
Organization
Hokkaido University Hospital
Division name
Center for Development of Advanced Diagnostics
Zip code
0608468
Address
N14W5, Kita-ku, Sapporo
TEL
011-706-7933
Homepage URL
aokumura@huhp.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co., Ltd.
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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
N14W5, Kita-ku, Sapporo
Tel
011-706-7636
crjimu@huhp.hokudai.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
北海道大学病院（北海道）、旭川医科大学病院（北海道）、KKR札幌医療センター（北海道）、手稲渓仁会（北海道）、札幌南三条病院（北海道）、帯広厚生病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 26 | 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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Exploratory Study
Management information
Registered date
| 2025 | Year | 03 | Month | 26 | Day |
Last modified on
| 2025 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065516
