UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054666 |
|---|---|
| Receipt number | R000062469 |
| Scientific Title | Clinical Validation Study of Plasma-based BRAF Gene Mutation Testing using LS104R in Metastatic Colorectal Cancer |
| Date of disclosure of the study information | 2024/06/14 |
| Last modified on | 2024/06/14 14:34:05 |
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Basic information
Public title
Clinical Validation Study of Plasma-based BRAF Gene Mutation Testing using LS104R in Metastatic Colorectal Cancer
Acronym
Clinical Validation Study of Plasma-based BRAF Gene Mutation Testing using LS104R in Metastatic Colorectal Cancer
Scientific Title
Clinical Validation Study of Plasma-based BRAF Gene Mutation Testing using LS104R in Metastatic Colorectal Cancer
Scientific Title:Acronym
Clinical Validation Study of Plasma-based BRAF Gene Mutation Testing using LS104R in Metastatic Colorectal Cancer
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To compare the concordance of BRAF mutational status between the plasma-based testing by LS104R using Plasma-Safe-SeqS technology (Test method) and MEBGEN RASKET-B kit (Reference method) which is approved as a companion diagnostic in Japan. Based on the result of this study, we consider whether the Test method can appropriately select the patient group eligible for the drug targeted by the Reference method.
Basic objectives2
Others
Basic objectives -Others
To compare the performance of the detection of the mutational status between newly developed plasma-based testing and approved tissue-based testing
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity and specificity of Test method compared to Reference method for the detection of BRAF V600E mutation.
Key secondary outcomes
-Diagnostic accuracy of Test method compared to Reference method.
-Positive predictive value (PPV) and negative predictive value (NPV) of Test method compared to Reference method.
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 with pathologically confirmed primary colorectal adenocarcinoma
-Patients who are planned to be tested or already tested for BRAF testing using the MEBGEN RASKET-B kit as part of routine clinical practice, and the tissue sample is free of modifying radiation therapy or drug therapy
-Patients aged 18 or older at the time of consent acquisition
-Patients whose blood sample can be collected before surgery or initiation of drug therapy
-Patients diagnosed with Stage IV or recurrent colorectal cancer by imaging findings
-Patients with no prior drug therapy, or patients confirmed progressive disease (PD) based on imaging or clinical PD during drug therapy without having initiated subsequent treatment
-Patient's written consent to participate in this study has been obtained
Key exclusion criteria
-Patients judged ineligible to participate in the study
-Patients previously enrolled in this study
-Patients with history of multiple cancer or with a comorbid multiple cancer
-Patients with synchronous or metachronous (within 5 years of disease-free interval) double cancer
Target sample size
113
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 Gastroenterology and Gastrointestinal Oncology
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan
TEL
04-7133-1111
tyoshino@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Nishida |
Organization
Sysmex Corporation
Division name
Medical & Scientific Affairs
Zip code
651-2271
Address
4-4-4 Takatsukadai, Nishi-ku, Kobe 651-2271, Japan
TEL
078-991-1911
Homepage URL
Nishida.Masahiro@sysmex.co.jp
Sponsor or person
Institute
Sysmex corporation
Institute
Department
Personal name
Funding Source
Organization
Sysmex corporation
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
Certified Review Board of National Cancer Center
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
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
国立研究開発法人 国立がん研究センター東病院(千葉県)/National Cancer Center Hospital East(Chiba)
国立大学法人 北海道大学病院(北海道)/Hokkaido University Hospital(Hokkaido)
埼玉県立がんセンター(埼玉県)/Saitama Cancer Center(Saitama)
公立大学法人 横浜市立大学附属市民総合医療センター(神奈川県)/ Yokohama City University Medical Center(Kanagawa)
独立行政法人国立病院機構 大阪医療センター(大阪府)/NHO Osaka National Hospital(Osaka)
地方独立行政法人大阪府立病院機構 大阪急性期・総合医療センター(大阪府)/Osaka General Medical Center(Osaka)
独立行政法人国立病院機構四国がんセンター(愛媛県)/Sikoku Cancer Center(Ehime)
国立大学法人 九州大学病院(福岡県)/Kyushu University Hospital(Fukuoka)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | 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
106
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-The Reference method is performed in routine clinical practice.
-The Test method is performed at Sysmex R&D center by the staff without being informed the results of the Reference method.
-Upon ensuring a thorough understanding of the content of this study, signed informed consent is obtained for their participation in this study and the secondary use of specimens and data.
-Subgroup analysis and additional analysis of discordant cases are conducted as exploratory analysis.
Management information
Registered date
| 2024 | Year | 06 | Month | 14 | Day |
Last modified on
| 2024 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062469
