UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011784
Receipt number R000013775
Scientific Title Clinical evaluation study of newly developed Luminex-based all RAS mutation assay kit
Date of disclosure of the study information 2013/09/18
Last modified on 2014/01/31 23:47:40

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Basic information

Public title

Clinical evaluation study of newly developed Luminex-based all RAS mutation assay kit

Acronym

Clinical evaluation study of newly developed Luminex-based all RAS mutation assay kit(RASKET (RAS KEy Testing) study)

Scientific Title

Clinical evaluation study of newly developed Luminex-based all RAS mutation assay kit

Scientific Title:Acronym

Clinical evaluation study of newly developed Luminex-based all RAS mutation assay kit(RASKET (RAS KEy Testing) study)

Region

Japan


Condition

Condition

Colorectal cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To evaluate whether a newly developed Luminex-based all RAS assay kit can detect all KRAS and NRAS gene mutations from FFPE (formalin-fixed paraffin embedded) samples in patients with advanced colorectal cancer.

Basic objectives2

Others

Basic objectives -Others

To compare the concordance between standard genetic testings including sanger sequencing and several established in vitro diagnostic (IVD) kits for KRAS exon2, and a newly developed Luminex-based all RAS assay kit for the detection of gene mutations.

Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Concordance rate of both KRAS and NRAS gene exon 2, 3 and 4 mutations between standard genetic testings including sanger sequencing and an established in vitro diagnostic (IVD) kit for KRAS exon2, and a newly developed Luminex-based all RAS assay kit

Key secondary outcomes

- Concordance rate of KRAS gene exon 3 and 4 mutations and NRAS gene exon 2, 3 and 4 mutations between sanger sequencing method and a newly developed Luminex-based all RAS assay kit in patients with KRAS exon 2 gene mutation negative.

- Comparison of genotypic variations concordance between sanger sequencing method and a newly developed Luminex-based RAS assay kit in both KRAS and NRAS gene exon 2, 3 and 4.


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) Samples histologically confirmed primary colorectal adenocarcinoma
2) Sufficient quantity of formalin-fixed paraffin embedded (FFPE) samples is available
3) Age greater than or equal to 20 years old
4) Document-Signed informed consent from patients

Key exclusion criteria

1) Patients judged as inappropriate for this study by investigator
2) Patients refusing a use of FFPE samples for the research

Target sample size

300


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 Hirotaka Hara

Organization

Medical Biological Laboratories Co.,LTD.

Division name

Intellectual Property and Clinical Development Department

Zip code


Address

KDX Nagoya Sakae Bldg. 10F, 4-5-3 Sakae, Naka-ku, Nagoya, Aichi, 460-0008 Japan

TEL

052-238-1901

Homepage URL


Email

hara.hirotaka@mbl.co.jp


Sponsor or person

Institute

Medical Biological Laboratories Co.,LTD.

Institute

Department

Personal name



Funding Source

Organization

Medical Biological Laboratories Co.,LTD.

Organization

Division

Category of Funding Organization

Self funding

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

愛知県がんセンター中央病院(愛知県)
大阪大学大学院医学系研究科(大阪府)
国立がん研究センター東病院(千葉県)
国立病院機構四国がんセンター(愛媛県)
埼玉県立がんセンター(埼玉県)
千葉県がんセンター(千葉県)


Other administrative information

Date of disclosure of the study information

2013 Year 09 Month 18 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

Completed

Date of protocol fixation

2013 Year 07 Month 26 Day

Date of IRB


Anticipated trial start date

2013 Year 09 Month 19 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2014 Year 01 Month 31 Day


Other

Other related information

- To compare the concordance between standard genetic testings including sanger sequencing and several established in vitro diagnostic (IVD) kits for KRAS exon 2, and a newly developed Luminex-based all RAS assay kit for the detection of RAS gene mutations including KRAS exon 2, 3, and 4, and NRAS exon 2, 3, and 4.
- Standard genetic testings set sanger sequencing for KRAS exon 3, 4 and NRAS exon 2, 3, and 4, and IVD kit for KRAS exon 2 (TheraScreen K-RAS Mutation Kit).
- Signed informed consent is obtained before using samples of the patient.
- Archived FFPE samples of colorectal adenocarcinoma are used as the patient's specimen.
- The patients who met eligibility are consecutively registered.


Management information

Registered date

2013 Year 09 Month 17 Day

Last modified on

2014 Year 01 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013775


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name