UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057382 |
|---|---|
| Receipt number | R000065567 |
| Scientific Title | An epidemiological study to confirm the prevalence of HER2 amplification in solid tumor in Japan using C-CAT database |
| Date of disclosure of the study information | 2025/03/31 |
| Last modified on | 2026/05/29 11:59:15 |
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Basic information
Public title
An epidemiological study to confirm the prevalence of HER2 amplification in solid tumor in Japan using C-CAT database
Acronym
An epidemiological study to confirm the prevalence of HER2 amplification in solid tumor in Japan using C-CAT database
Scientific Title
An epidemiological study to confirm the prevalence of HER2 amplification in solid tumor in Japan using C-CAT database
Scientific Title:Acronym
An epidemiological study to confirm the prevalence of HER2 amplification in solid tumor in Japan using C-CAT database
Region
| Japan |
Condition
Condition
Advanced solid tumor
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The objective of the study is to confirm HER2 amplification prevalence of solid tumors as a whole and each tumor type in Japan.
In addition, patients will be divided into two cohorts according to the positive or negative of HER2 amplification, and the background information and genetic alterations of each cohort will be confirmed.
Basic objectives2
Others
Basic objectives -Others
Epidemiological study using C-CAT database
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of HER2 amplification (overall and each tumor type)
Background information, genetic alterations, Status of the treatment after Expert Panel, breakdown
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
Patients who meet all the following conditions will be included.
1) patients registered in C-CAT data base for the period from June 1, 2019, to December 31, 2024
2) Patients with solid tumors
Key exclusion criteria
Patients who meet any of the following conditions will be excluded.
1) Patients whose "previous registration" is "Yes" or "Unknown"
2) Patients whose CGP test results were not analyzed
Target sample size
90000
Research contact person
Name of lead principal investigator
| 1st name | Kazuto |
| Middle name | |
| Last name | Sato |
Organization
Daiichi Sankyo Co., Ltd.
Division name
Oncology Medical Science Department I
Zip code
103-8426
Address
3-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan
TEL
03-6225-1111
kazuto.sato@daiichisankyo.com
Public contact
Name of contact person
| 1st name | Daiichi Sankyo |
| Middle name | |
| Last name | Contact for JP-MA Clinical Study Information |
Organization
Daiichi Sankyo Co., Ltd.
Division name
Oncology Medical Science Department I
Zip code
103-8426
Address
3-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan
TEL
03-6225-1111
Homepage URL
contact_for_DSMA_JP@daiichisankyo.com
Sponsor or person
Institute
Daiichi Sankyo Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Daiichi Sankyo Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethical Research Practice Committee for Research on Human Tissue, Information, and Other Human Material
Address
1-2-58, Hiromachi, Shinagawa-ku, Tokyo
Tel
03-3492-3131
zzjp0327@daiichisankyo.com
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
| 2025 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/1718-7729/33/4/195
Number of participants that the trial has enrolled
96971
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
Completed
Date of protocol fixation
| 2025 | Year | 03 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Observational cohort study using C-CAT database
Management information
Registered date
| 2025 | Year | 03 | Month | 24 | Day |
Last modified on
| 2026 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065567
