UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000023039
Receipt number	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 16:10:28

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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

Colorectal cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

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 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

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Value
https://center6.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