UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050330 |
|---|---|
| Receipt number | R000057242 |
| Scientific Title | An observational study of ALK-IHC screening for advanced or metastatic solid tumors(WJOG15221MPS) |
| Date of disclosure of the study information | 2023/02/14 |
| Last modified on | 2023/04/07 11:13:12 |
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Basic information
Public title
An observational study of ALK-IHC screening for advanced or metastatic solid tumors(WJOG15221MPS)
Acronym
An observational study of ALK-IHC screening
Scientific Title
An observational study of ALK-IHC screening for advanced or metastatic solid tumors(WJOG15221MPS)
Scientific Title:Acronym
An observational study of ALK-IHC screening
Region
| Japan |
Condition
Condition
advanced or metastatic solid tumors
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To perform immunohistochemical staining (IHC) for ALK using tumor tissue to identify eligible patients for the "Multicenter Phase II Basket Trial of Brigtinib in Advanced or Recurrent Solid Tumors with ALK Fusion Gene Positivity". In addition, the proportion of ALK-IHC-positive patients with advanced or recurrent solid tumors should be examined in terms of cancer type and histology.
Basic objectives2
Others
Basic objectives -Others
the positivity ratio of ALK-IHC in solid tumors
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Examine the positivity ratio of ALK-IHC in solid tumors
Key secondary outcomes
The proportion of patients with IHC test results and their prognosis will also be examined.
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
1) Histopathologically confirmed diagnosis of solid tumor
2) advanced or metastatic solid tumors
3) Chemotherapy is being or is scheduled to be administered
4) Expected to survive at least 12 weeks
5) Written consent has been obtained.
6) Tumor tissue samples can be submitted
Key exclusion criteria
1) Patients diagnosed with non-small cell lung cancer
2) Patients considered unsuitable to be enrolled in this study by their attending physicians
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Toshiki |
| Middle name | |
| Last name | Masuishi |
Organization
Aichi Cancer Center Hospital
Division name
Department of Clinical Oncology
Zip code
464-8681
Address
1-1, Kanokoden, Chikusa-ku, Nagoya city, Aichi
TEL
052-762-6111
irb@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Nakamura |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
556-0016
Address
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
other
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited.
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
Aichi Cancer Center Institutional Review Board
Address
1-1, Kanokoden, Nagoya, Aichi
Tel
052-762-6111
irb@aichi-cc.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
| 2023 | Year | 02 | Month | 14 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To perform immunohistochemical staining (IHC) for ALK using tumor tissue to identify eligible patients for the "Multicenter Phase II Basket Trial of Brigatinib in Advanced or Recurrent Solid Tumors with ALK Fusion Gene Positive". In addition, the proportion of ALK-IHC positive patients with advanced or recurrent solid tumors should be examined in terms of cancer type and histology.
Management information
Registered date
| 2023 | Year | 02 | Month | 14 | Day |
Last modified on
| 2023 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057242
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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