UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051303 |
|---|---|
| Receipt number | R000057482 |
| Scientific Title | Clinical Performance Test of Reagent for BRAF Gene Mutation Detection in Solid Tumors |
| Date of disclosure of the study information | 2023/06/12 |
| Last modified on | 2023/06/12 17:33:11 |
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Basic information
Public title
Clinical Performance Test of Reagent for BRAF Gene Mutation Detection in Solid Tumors
Acronym
BRAF Clinical Performance Test
Scientific Title
Clinical Performance Test of Reagent for BRAF Gene Mutation Detection in Solid Tumors
Scientific Title:Acronym
Clinical Performance Test of Reagent for BRAF Gene Mutation Detection in Solid Tumors
Region
| Japan |
Condition
Condition
Solid tumors and hairy cell leukemia
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
| Hematology and clinical oncology | Urology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
In the analysis of BRAF gene mutation (in this protocol, BRAF gene mutation means a point mutation at codon 600 of the BRAF gene that causes an amino acid mutation from valine to glutamic acid (V600E)), the BRAF gene mutation detection reagent (hereinafter "the Reagent") The reagent for BRAF gene mutation detection (hereafter, the reagent) will be tested to see if it shows the same clinical usefulness as the THxID BRAF kit (approval number: 22800EZX00005000) (hereafter, the control method) using the Real-Time PCR method (hereafter, the control method).*1:In this proposal, BRAF gene mutation means a point mutation at codon 600 of the BRAF gene that causes a valine to glutamic acid amino acid mutation (V600E).
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The agreement rate between the results of the control method and this reagent will be analyzed to examine the validity of the results. A crosstabulation table is prepared for the results of the control method and "the Reagent", in which the number of specimens for each result is tabulated, and the overall concordance rate, positive concordance rate, and negative concordance rate are calculated. Specimens for which the results of the control method or this reagent are not available are excluded from this analysis. Specimens determined to have a BRAF gene mutation (V600K) that is not V600E by the control method will be treated as negative in this study.
Key secondary outcomes
If the enrolled cases were accompanied by BRAF gene determination results other than those of the control method, the agreement between the determination results of "the Reagent" and those of the control method will be calculated in the same manner as for the control method.
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.Consent has been obtained for the use of samples and information for future medical research in the MONSTAR-SCREEN, GI-SCREEN 2015-01-Non CRC, or GOZILA Study trials, or in the National Cancer Institute's blanket consent*.
2.Patients have been histologically or cytologically diagnosed with solid malignancy or hairy cell leukemia.
3.Sufficient tumor tissue or DNA extracted from tumor tissue can be provided for the examination in this study.
*Thyroid cancer, pancreatic cancer, biliary tract cancer, neuroendocrine cancer, prostate cancer, and cancer of unknown primary among those who received comprehensive consent and underwent comprehensive cancer genome profiling testing between April 01, 2012 and December 31, 2022 at the National Cancer Center Hospital East, The comprehensive consent cases will be used for those cancer types for which the number of required specimens is insufficient from the MONSTAR-SCREEN study and other studies.
Key exclusion criteria
1.Cases in which the patient has indicated his/her intention to refuse the use of the sample/information for this study from the start of this study to the start of the analysis.
2.Cases in which the patient is a minor.
Target sample size
138
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Yoshino |
Organization
National Cancer Center Hospital East
Division name
Department for the Promotion of Drug and Diagnostic Development
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shi, Chiba
TEL
0471331111
tyoshino@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Nakamura |
Organization
National Cancer Center Hospital East
Division name
Department for the Promotion of Drug and Diagnostic Development, Drug and Diagnostic Promotion
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shi, Chiba
TEL
0471331111
Homepage URL
yoshinak@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Takayuki Yoshino
Funding Source
Organization
MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.
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
National Cancer Center Institutional Review Board
Address
5-1-1, tsukiji,tyuo-ku,Tokyo
Tel
03-3542-2511
NCC-IRBoffice@ml.res.ncc.go.jp
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 12 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design
1) The National Cancer Center Hospital East will confirm the existence of informed consent for existing samples and information, and prepare a list of specimens to be used in this study (specimen list).
2) The National Cancer Center Hospital East will share the specimens necessary for this study with G&G and clinical information with the MBL Regulatory Affairs and Clinical Development Department. In the case of secondary use of samples from the MONSTAR-SCREEN trial, etc., samples necessary for this study from the collaborating institutions in the MONSTAR-SCREEN trial, etc. will be shared with G&G, and clinical information from the National Cancer Center Hospital East will be shared with the MBL Regulatory Affairs and Clinical Development Department.
3) G&G will perform BRAF gene mutation testing using the reagent and control method on the provided samples, and report the test results to the MBL Regulatory Affairs & Clinical Development Department.
4) The MBL Regulatory Affairs & Clinical Development Department will request the laboratory to perform a discrepancy check if there is a sample that does not match the test result of the control method and this reagent.
5) The laboratory that conducted the discrepancy investigation reports the results to the MBL Regulatory Affairs and Clinical Development Department.
MBL submits the case report to the National Cancer Center Hospital East.
7) Using the specimen list, the person in charge of analysis at MBL (who is not involved in the measurement of this study) will analyze the test results.
8) Based on the analysis results, the MBL Regulatory Affairs and Clinical Development Department will prepare a study result report.
9) MBL will submit the study result report to the National Cancer Center Hospital East.
10) If there are any residual specimens from this study, G&G will store them. In addition, a storage list indicating the amount of residual specimens will be prepared and stored.
Management information
Registered date
| 2023 | Year | 06 | Month | 09 | Day |
Last modified on
| 2023 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057482
