NCT01744860已完成不适用
Evaluation of Concordance Between the Methods Used in INCa Platforms and the Cobas® 4800 BRAF V600 Mutation Test for Detection of BRAF V600 Mutations in Melanoma in Real Life Setting
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 420
- 主要终点
- BRAF Mutation Status According to Cobas 4800 BRAF V600 Mutation Test vs. INCa Laboratories Molecular Genetics Laboratories
研究概览
简要总结
This non-interventional study will compare the Cobas BRAF V600 mutation assay with in-house methods used in molecular laboratories for the assessment of the BRAF mutation status in melanoma tumor samples. No patients will be enrolled in this study. Data will be collected for approximately 6 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No patients are enrolled. Use of tumor samples only.
- •Histologically proven melanoma tumor sample
- •Any type of tumor sample: biopsy or surgical specimen of primary tumor or metastasis
- •Tumor samples must be fixed and paraffin-embedded.
排除标准
- •No patients are enrolled. Use of tumor samples only.
- •Fixative unknown
结局指标
主要结局
BRAF Mutation Status According to Cobas 4800 BRAF V600 Mutation Test vs. INCa Laboratories Molecular Genetics Laboratories
时间窗: Up to 6 months
BRAF V600 mutation status was determined by INCa molecular laboratories "in-house" methods and Cobas 4800 BRAF V600 mutation test. Samples were analysed as V600 mutation, No V600 mutation and Non evaluable. Additionally, the type of V600 mutation (E, K, R, D, E2, other V600 mutation, not specified) was also evaluated only by INCa molecular laboratory "in-house" method.
次要结局
- Tumor Sample Characteristics-Type of Tumor Sample(Up to 6 months)
- Type of Fixative Used- Pre-analytical Method(Up to 6 months)
- Dewaxing by Pre-analytical Method(Up to 6 Months)
- Size of Amplicons Used by "In-house" Analytical Method(Up to 6 months)
- Method of Mutation Detection by "In-house" Analytical Method(Up to 6 months)
- Technician Work Time Between DNA Extraction and Result by "In-house" Analytical Method(Up to 6 months)
- Time From Sampling to Fixation- Pre-analytical Method(Up to 6 months)
- Fixation Duration by Pre-analytical Method(Up to 6 months)
- Slice Thickness by Pre-analytical Method(Up to 6 months)
- Number of Samples Punched in In-house Analytical Method(Up to 6 months)
- Median Time Between Receipt of Samples and Determination of Result by "In-house" Analytical Method(Up to 6 months)
- Necrosis Percentage Determination by Pre-analytical Method(Up to 6 months)
- Percentage of Tumor Cells by Pre-analytical Method(Up to 6 months)
- Tumor Samples With Presence of Melanin by Pre-analytical Method(Up to 6 months)
- DNA Extraction - Extraction Method by Pre-analytical Method(Up to 6 months)
- Mean DNA Concentration by Pre-analytical Method(Up to 6 months)
- Amount of DNA by Pre-analytical Method(Up to 6 months)
- Number of Slices Used When No Punch Was Used for Cobas 4800 BRAF V600 Mutation Test- Analytical Method(Up to 6 months)
- Median Time Between Receipt of Sample and Determination of Result by Cobas 4800 BRAF V600 Mutation Test -Analytical Method(Up to 6 months)
- Tumor Sample Characteristics - Source of Tumor Sample(Up to 6 months)
- Type of Pathology Laboratory Performing the Fixation or Embedding-Pre-analytical Method(Up to 6 months)
- Median DNA Elution Volume by Pre-analytical Method(Up to 6 months)
- Mean Number of Slices Per Sample Used for "In-house"- Analytical Method(Up to 6 months)
- Punch Used for Cobas 4800 BRAF V600 Mutation Test- Analytical Method(Up to 6 months)
- Management of Discordance-Final Result for BRAF V600 Mutation Detection(Up to 6 months)
- Management of Discordance- Method Used to Manage Discordance(Up to 6 months)
- Mean DNA Concentration as Measured by COBAS 4800 BRAF V600 Mutation Test-Analytical Method(Up to 6 months)
- Technician Work Time Between DNA Extraction and Result by Cobas 4800 BRAF V600 Mutation Test - Analytical Method(Up to 6 months)
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