UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061106 |
|---|---|
| Receipt number | R000069923 |
| Scientific Title | Evaluation of HER3 Expression as a Predictive Biomarker for Anti-EGFR Therapy in RAS Wild-Type Unresectable Advanced or Recurrent Colorectal Cancer |
| Date of disclosure of the study information | 2026/03/31 |
| Last modified on | 2026/03/30 17:18:17 |
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Basic information
Public title
Evaluation of HER3 Expression as a Predictive Biomarker for Anti-EGFR Therapy in RAS Wild-Type Unresectable Advanced or Recurrent Colorectal Cancer
Acronym
HER3 significance in advanced CRC
Scientific Title
Evaluation of HER3 Expression as a Predictive Biomarker for Anti-EGFR Therapy in RAS Wild-Type Unresectable Advanced or Recurrent Colorectal Cancer
Scientific Title:Acronym
HER3 significance in advanced CRC
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To utilize data from an ancillary study of the PARADIGM trial to clarify the clinical significance of HER3 (ERBB3) expression levels and verify its utility as a predictive biomarker for anti-EGFR therapy.
Basic objectives2
Others
Basic objectives -Others
To evaluate the relationships between HER3 expression and other gene alterations
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between overall survival (OS) and HER3 (ERBB3) expression levels
Key secondary outcomes
Association between progression-free survival (PFS) and HER3 (ERBB3) expression levels
Association between objective response rate (ORR) and HER3 (ERBB3) expression levels
Association between disease control rate (DCR) and HER3 (ERBB3) expression levels
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients who consented to participate in an ancillary study of the PARADIGM trial
2)Patients who enrolled in the PARADIGM trial between May 2015 and June 2017
Key exclusion criteria
1) Cases excluded from the analysis in an ancillary study of the PARADIGM trial
Target sample size
790
Research contact person
Name of lead principal investigator
| 1st name | Tadayoshi |
| Middle name | |
| Last name | Hashimoto |
Organization
National Cancer Center Hospital East
Division name
Division for the Promotion of Drug and Diagnostic Development
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
tyoshino@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Kazumasa |
| Middle name | |
| Last name | Yamamoto |
Organization
National Cancer Center Hospital East
Division name
Department of Gastroenterology and Gastrointestinal Oncology
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
Homepage URL
kayamam6@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Department for the Promotion of Drug and Diagnostic Development,Translational Research Support Office
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
National Cancer Center Institutional Review Board
Address
5-1-1,tsukiji,chuo-ku,Tokyo
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.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 | 03 | Month | 31 | 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 | 01 | Month | 13 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2026 | 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
Study Design: Observational study
Target population:the patients who meet the selection criteria until March 31 2027 from research permit date
Management information
Registered date
| 2026 | Year | 03 | Month | 30 | Day |
Last modified on
| 2026 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069923
