UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054664 |
|---|---|
| Receipt number | R000062468 |
| Scientific Title | Clinical Validation Study of Plasma-based RAS 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 13:51:52 |
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Basic information
Public title
Clinical Validation Study of Plasma-based RAS Gene Mutation Testing using LS104R in Metastatic Colorectal Cancer
Acronym
Clinical Validation Study of Plasma-based RAS Gene Mutation Testing using LS104R in Metastatic Colorectal Cancer
Scientific Title
Clinical Validation Study of Plasma-based RAS Gene Mutation Testing using LS104R in Metastatic Colorectal Cancer
Scientific Title:Acronym
Clinical Validation Study of Plasma-based RAS 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
NO
Objectives
Narrative objectives1
To evaluate the clinical validity of the plasma-based testing by LS104R using Plasma-Safe-SeqS technology (Test method) in patients with metastatic colorectal cancer by comparing the concordance of RAS mutational status between the Test method and the plasma-based testing approved for marketing in Japan (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 plasma-based testing
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) of both KRAS and NRAS gene exon 2, 3 and 4 mutations between Test method and Reference method
Key secondary outcomes
1. Overall percent agreement (OPA) between Test method and Reference method
2. Positive predictive value (PPV) and negative predictive value (NPV) between Test method and Reference method
3. Codon-based concordance rate between Test method and Reference method in RAS mutation-positive cases
4. MAF correlation between Test method and Reference method in RAS mutation-positive cases
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cohort A
-Plasma samples (including DNA extracted from plasma samples) collected and stored from patients who have consented to secondary use of samples and data in the REMARRY study (UMIN000036424).
-Plasma samples collected and stored from patients who confirmed progressive disease (PD) based on imaging or clinical PD before initiating subsequent treatment in the REMARRY study
-Plasma samples that tested for RAS testing using the OncoBEAMTM RAS CRC kit with valid codon results at all codons in the REMARRY study
-Plasma samples with a stored volume of more than 3 mL
Cohort B
-Plasma samples collected and stored from patients who have consented to secondary use of samples and data in the Lung mets shedding study (UMIN000045411)
-Plasma samples that tested for RAS testing using the OncoBEAMTM RAS CRC kit with valid results at all codons in the Lung mets shedding study
-Plasma samples with a stored volume of more than 3 mL
Key exclusion criteria
N/A
Target sample size
128
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-shi 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)
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)
国立大学法人 北海道大学病院 (北海道)/Hokkaido University Hospital(Hokkaido)
国立病院機構 大阪医療センター（大阪府）/ Osaka National Hospital (Osaka)
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
128
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 | 06 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-In this study, the results of the Test method with Reference methods are compared using plasma samples derived from patients tested with the OncoBEAMTM RAS CRC kit in two previous studies (REMARRY study and Lung mets shedding study).
-The RAS genes to be evaluated are exons 2 (codons 12 and 13), exons 3 (codons 59 and 61), and exons 4 (codons 117 and 146) of the KRAS and NRAS genes.
-After the samples derived from two cohorts (cohort A: REMARRY study, cohort B: Lung mets shedding study) are blinded, the Test method is performed at the Sysmex R&D center by the staff without being informed the results of the Reference method.
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=R000062468
