UMIN-CTR Clinical Trial

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

Colorectal cancer

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

YES

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Medical Biological Laboratories Co.,LTD.

Institute

Department

Personal name

Organization

Medical Biological Laboratories Co.,LTD.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2013

Year

09

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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