UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050149 |
|---|---|
| Receipt number | R000056972 |
| Scientific Title | Biomarkers exploratory research accompanying A Multicenter Phase II Clinical Study Evaluating the Efficacy and Safety of Neoadjuvant and Adjuvant Chemotherapy with Encorafenib, Binimetinib Plus Cetuximab in Patients with Surgically Resectable BRAF V600E Mutant Colorectal Metastasis |
| Date of disclosure of the study information | 2023/01/27 |
| Last modified on | 2024/01/29 13:36:40 |
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Basic information
Public title
Exploratory research of biomarkers associated with NEXUS study
Acronym
NEXUS-Study-TR study
Scientific Title
Biomarkers exploratory research accompanying A Multicenter Phase II Clinical Study Evaluating the Efficacy and Safety of Neoadjuvant and Adjuvant Chemotherapy with Encorafenib, Binimetinib Plus Cetuximab in Patients with Surgically Resectable BRAF V600E Mutant Colorectal Metastasis
Scientific Title:Acronym
NEXUS-Study-TR study
Region
| Japan |
Condition
Condition
Patients with surgically resectable BRAF V600E mutant colorectal metastasis.
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology | Hepato-biliary-pancreatic surgery |
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to conduct an exploratory analysis of biomarkers that correlate with prognosis for targeting patients enrolled in NEXUS study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overrall Survaival
Key secondary outcomes
Progression Free Survial, Disease-Free Survial
Base
Study type
Others,meta-analysis etc
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
Patients with resectable metastatic colorectal cancer with BRAF V600E mutations enrolled in the NEXUS study are eligible.
Key exclusion criteria
Patients enrolled in the NEXUS study who indicated their intention to refuse to participate in this research
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Yoshino |
Organization
National Cancer Center Hospital East
Division name
Department of Gastrointestinal Oncology
Zip code
277-8577
Address
6-5-1, kahiwanoha, Kshiwa, chiba, 277-8577, Japan
TEL
0471331111
nexus_core@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Shin |
| Middle name | |
| Last name | Kobayashi |
Organization
National Cancer Center Hospital East
Division name
Department of Hepatobiliary and Pancreatic Surgery
Zip code
277-8577
Address
6-5-1, kahiwanoha, Kshiwa, chiba, 277-8577, Japan
TEL
0471331111
Homepage URL
nexus_core@east.ncc.go.jp
Sponsor or person
Institute
National Caner Cednyter Hosipital East
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Research Ethics Review Committee
Address
6-5-1, kahiwanoha, Kshiwa, chiba, 277-8577, Japan
Tel
0471331111
irst@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
| 2023 | Year | 01 | Month | 27 | 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 | 07 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The design of this study was based on registration data from the PRECISION study, the SCRUM-Japan MONSTAR-SCREEN-2 study, and the GALAXY study, which were enrolled at the same time as the NEXUS study (including both single study participants and multiple overlapping participants). A multicenter retrospective cohort study with secondary use of , using only existing information. The observation period will be the same as the NEXUS study.
Management information
Registered date
| 2023 | Year | 01 | Month | 26 | Day |
Last modified on
| 2024 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056972
| 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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| Registered date | File name |
