UMIN-ICDS Clinical Trial

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

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

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

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.

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.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

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

Email

tyoshino@east.ncc.go.jp

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

Email

yoshinak@east.ncc.go.jp

Institute

National Cancer Center Hospital East

Institute

Department

Personal name

Takayuki Yoshino

Organization

MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

National Cancer Center Institutional Review Board

Address

5-1-1, tsukiji,tyuo-ku,Tokyo

Tel

03-3542-2511

Email

NCC-IRBoffice@ml.res.ncc.go.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

06

Month

12

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

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 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.

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/icdr_e/ctr_view.cgi?recptno=R000057482