UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061732 |
|---|---|
| Receipt number | R000070617 |
| Scientific Title | Detection characteristics of ALK fusion genes in surgically resected lung cancer specimens using immunohistochemistry and multigene PCR panel |
| Date of disclosure of the study information | 2026/05/29 |
| Last modified on | 2026/05/29 12:35:59 |
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Basic information
Public title
Detection characteristics of ALK fusion genes in surgically resected lung cancer specimens using immunohistochemistry and multigene PCR panel
Acronym
DET-ALK study
Scientific Title
Detection characteristics of ALK fusion genes in surgically resected lung cancer specimens using immunohistochemistry and multigene PCR panel
Scientific Title:Acronym
DET-ALK study
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
| Laboratory medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This study aims to retrospectively evaluate the detection characteristics of ALK fusion genes based on test results obtained by immunohistochemistry (IHC) and the AmoyDx assay.
Basic objectives2
Others
Basic objectives -Others
Utility of additional IHC testing.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The number and proportion of ALK fusion positive cases identified by immunohistochemistry (IHC) among cases that were negative for all driver gene alterations by the AmoyDx assay.
Key secondary outcomes
The number and proportion of ALK fusion gene detection by the AmoyDx assay before and after changes in specimen handling procedures, etc.
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) Histologically diagnosed as non-small cell lung cancer using surgically resected specimens.
(2) Meeting one of the following conditions:
(a) Surgery was performed between January 2018 and December 2021, and ALK testing by IHC was conducted using surgical specimens.
(b) Surgery was performed between January 2022 and December 2025, and ALK testing by the AmoyDx assay was conducted using surgical specimens.
Key exclusion criteria
(1) Cases in which the study participant (or a legally authorized representative) expressed a wish not to participate in the study.
(2) Cases unable to undergo additional IHC testing because of insufficient remaining specimen material.
Target sample size
1004
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Onodera |
Organization
Tohoku University Hospital
Division name
Department of Thoracic Surgery
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-8521
ken.onodera.c3@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Onodera |
Organization
Tohoku University Hospital
Division name
Department of Thoracic Surgery
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-8521
Homepage URL
ken.onodera.c3@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
Tel
022-728-4105
ec-med@grp.tohoku.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
東北大学病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 29 | 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 | 05 | Month | 27 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multiplex test negative, cold ischemia time, Refrigerated storage
Management information
Registered date
| 2026 | Year | 05 | Month | 29 | Day |
Last modified on
| 2026 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070617
