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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000023039
Receipt No. R000026554
Scientific Title Multicenter Clinical Performance Study to evaluate Plasma-based RAS Gene Mutation Testing using OncoBEAM RAS CRC assay (LS52R) of Patients having Progressive or Recurrent Colorectal Cancer
Date of disclosure of the study information 2016/07/11
Last modified on 2018/07/10

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Basic information
Public title Multicenter Clinical Performance Study to evaluate Plasma-based RAS Gene Mutation Testing using OncoBEAM RAS CRC assay (LS52R) of Patients having Progressive or Recurrent Colorectal Cancer
Acronym OncoBEAM RAS(OncoBEAM-R) Study
Scientific Title Multicenter Clinical Performance Study to evaluate Plasma-based RAS Gene Mutation Testing using OncoBEAM RAS CRC assay (LS52R) of Patients having Progressive or Recurrent Colorectal Cancer
Scientific Title:Acronym OncoBEAM RAS(OncoBEAM-R) Study
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 usefulness of newly plasma-based RAS gene mutation testing using BEAMing technology (Plasma RAS testing) by comparing concordance of RAS mutation status with same patient's tissue-based RAS testing (Reference method)
Basic objectives2 Others
Basic objectives -Others To compare the concordance of results of plasma RAS testing with those obtained by reference standard RAS testing of tumor tissue
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Overall percent agreement (OPA) of both KRAS and NRAS gene exon 2, 3 and 4 mutations between Plasma RAS testing and Reference method
Key secondary outcomes ・Positive percent agreement (PPA) and negative percent agreement (NPA) between Plasma RAS testing and Reference method
・Positive predictive value (PPV) and negative predictive value (NPV) of the Plasma RAS testing versus Reference method
・Codon-based consistency of Plasma RAS testing results with those obtained using the and Reference method in patients identified with RAS mutation

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 1)Patients with pathologically confirmed primary colorectal adenocarcinoma
2)Patients aged 20 or older at the time of the informed consent
3)Patients who signed informed consent form
4)Patients whose blood collection is possible before a treatment start
5)Patients confirmed Stage4 colorectal cancer by imaging findings
6)Patients with no previous chemotherapy, or patients whose PD or clinical PD was confirmed before starting next treatment
Key exclusion criteria 1)Patients judged ineligible to participate in the study
2)Patients registered to the study in the past
3)Patients with a history of multiple cancer or with a comorbid multiple cancer
4)Patients with synchronous or metachronous (a disease-free interval of five years or shorter) double cancer
5)Patients with histories of treatment using drugs targeting EGFR such as an anti-EGFR antibody or Regorafenib
Target sample size 350

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takayuki Yoshino
Organization National Cancer Center Hospital East
Division name Department of Gastroenterology and Gastrointestinal Oncology
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan
TEL 04-7133-1111
Email tyoshino@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Kumamoto
Organization Sysmex corporation
Division name Clinical Affairs
Zip code
Address 1-3-2,Murotani, Nishi-ku, Kobe,
TEL 078-991-7501
Homepage URL
Email Kumamoto.Hiroshi@sysmex.co.jp

Sponsor
Institute Sysmex corporation
Institute
Department

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
Address
Tel
Email

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)
千葉県がんセンター (千葉県)/Chiba Cancer Center(Chiba)
埼玉県立がんセンター (埼玉県)/Saitama Cancer Center(Saitama)
独立行政法人 労働者健康福祉機構 関西労災病院 (兵庫県)/Kansai Rosai Hospital(Hyogo)
国立大学法人 大阪大学医学部附属病院 (大阪府)/Osaka University Hospital(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
2016 Year 07 Month 11 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications https://www.esmo.org/Conferences/World-GI-2018-Gastrointestinal-Cancer
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 Main results already published
Date of protocol fixation
2016 Year 06 Month 21 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information ・The results of Plasma RAS testing are compared with the results of standard RAS testing such as in vitro diagnostic(IVD)as further analysis.
・Signed Informed Consent is obtained before blood collection and using tissue samples.
・Archival FFPE samples or FFPE samples from surgically-resected tissue at next treatment are used as tissue samples.
・The patients who meet eligibility are consecutively registered.

Management information
Registered date
2016 Year 07 Month 06 Day
Last modified on
2018 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026554

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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