UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022742 |
|---|---|
| Receipt number | R000026203 |
| Scientific Title | Clinical validation study of RAKSET-B, a multiple detection kit for BRAF and RAS gene mutations in colorectal cancer |
| Date of disclosure of the study information | 2016/06/15 |
| Last modified on | 2017/02/28 10:24:23 |
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Basic information
Public title
Clinical validation study of RAKSET-B, a multiple detection kit for BRAF and RAS gene mutations in colorectal cancer
Acronym
RAKSET-B study
Scientific Title
Clinical validation study of RAKSET-B, a multiple detection kit for BRAF and RAS gene mutations in colorectal cancer
Scientific Title:Acronym
RAKSET-B study
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Laboratory medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate whether a newly developed xMAP (Luminex) technology-based BRAF and RAS (KRAS and NRAS) gene mutation detection kit can detect BRAF and RAS 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 testing including sanger sequencing, pyrosequencing and established in vitro diagnostic (IVD) kit for detecting RAS mutations, and a newly developed xMAP (Luminex)-based BRAF and RAS gene mutation detection kit
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
BRAF gene mutation*
- Overall concordance rate, positive concordance rate, and negative concordance rate of BRAF gene mutations between standard genetic testing such as sanger sequencing and RASKET-B kit
RAS gene mutation**
- Overall concordance rate, positive concordance rate, and negative concordance rate of RAS gene mutations between MEBGEN RASKET KIT (an established in vitro diagnostic (IVD) kit for detecting RAS mutations) and RASKET-B kit
*BRAF gene mutation
codon 600 (p.V600E)
**RAS gene mutation
codon 12, 13, 59, 61, 117, 146
Key secondary outcomes
BRAF gene mutation
- Consistency of BRAF gene mutation status between pyrosequencing and RASKET-B kit
- Comparison of genotypic variations between sanger sequencing and RASKET-B kit
RAS gene mutation
- Consistency of RAS gene mutation status between sanger sequencing and RASKET-B kit
- Comparison of genotypic variations between sanger sequencing and RASKET-B kit
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) Histologically confirmed primary colorectal adenocarcinoma
2) 20 years or older at the recruitment
3) Informed consent document signed by patients who then do not declare their intention of consent withdrawal, or performed the procedure for existing sample and information to be used in the trial, according to the plan approved by the IRB committee at each institution
4) Sufficient quantity of the DNA from FFPE samples is available
Key exclusion criteria
1) Inappropriate for this trial by investigators
2) Patients refusing a use of FFPE samples for the trial
3) The result of the RAS genetic test wasn't adequately obtained in the RASKET study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroya Taniguchi |
Organization
Aichi Cancer Center Hospital
Division name
Department of Clinical Oncology
Zip code
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681 Japan
TEL
052-762-6111
h.taniguchi@aichi-cc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Fukushima |
Organization
Medical Biological Laboratories Co.,LTD.
Division name
Regulatory Affairs 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
fukushima.yoshiyuki@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
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
| 2016 | Year | 06 | Month | 15 | 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
| 2016 | Year | 03 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 02 | Month | 28 | Day |
Other
Other related information
To evaluate whether a newly developed xMAP (Luminex) technology-based BRAF and RAS (KRAS and NRAS) gene mutation detection kit can detect BRAF and RAS gene mutations from FFPE (formalin-fixed paraffin embedded) samples in patients with advanced colorectal cancer.
Informed consent document signed by patients who then do not declare their intention of consent withdrawal, or performed the procedure for existing sample and information to be used in the trial, according to the plan approved by the IRB committee at each institution.
Sufficient quantity of the DNA from FFPE samples is available.
Management information
Registered date
| 2016 | Year | 06 | Month | 15 | Day |
Last modified on
| 2017 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026203
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