Clinical Performance Test of Reagent for BRAF Gene Mutation Detection in Solid Tumors

Clinical Performance Test of Reagent for BRAF Gene Mutation Detection in Solid Tumors - Clinical Performance Test of Reagent for BRAF Gene Mutation Detection in Solid Tumors

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000051303

Enrollment

138

Registered

2023-06-12

Start date

2023-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid tumors and hairy cell leukemia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Secondary

Measure	Time frame
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.	—

Countries

Japan

Contacts

Public ContactYoshiaki Nakamura

National Cancer Center Hospital East Department for the Promotion of Drug and Diagnostic Development, Drug and Diagnostic Promotion

yoshinak@east.ncc.go.jp0471331111

Outcome results