NCT02663232已完成不适用
Epidemiological Study of V600 BRAF Mutation in Spanish Patients Diagnosed With Metastatic Melanoma: ABSOLUT-BRAF Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 264
- 主要终点
- Percentage of Participants With V600 BRAF Mutation Status
研究概览
简要总结
This is a national, multicenter, cross-sectional epidemiological study in adult Spanish participants diagnosed with advanced or metastatic melanoma.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Valid tumor samples from participants diagnosed with Stage IIIc or IV melanoma
- •Written informed consent granted
排除标准
- •Do not fulfill one or more inclusion criteria
结局指标
主要结局
Percentage of Participants With V600 BRAF Mutation Status
时间窗: Day 1
Presence or absence of mutations in the V600 BRAF oncogene was determined in all eligible participants. Data collection and management of BRAF mutation testing was carried out using the Biomarker point® online platform. The platform was used as an electronic case report form (e-CRF) for collecting information in electronic format via a website. Percentage of participants with BRAF mutation status (mutated BRAF, wild type, not available) were reported.
次要结局
- Percentage of Participants With Adequate Quality/Quantity of Tumor Sample(Day 1)
- Percentage of Participants With Sun Exposure(Day 1)
- Percentage of Participants Categorized By LDH Level(Day 1)
- Percentage of Participants Categorized by Method of Fixation (Buffered Formalin or Others)(Day 1)
- Percentage of Participants With Family History of Melanoma(Day 1)
- Percentage of Participants Categorized by Primary Tumor Location(Day 1)
- Median Time Since Diagnosis of Melanoma(Day 1)
- Percentage of Participants Categorized by Breslow Thickness(Day 1)
- Percentage of Participants With Ulceration(Day 1)
- Percentage of Participants Categorized by Melanoma Stage(Day 1)
- Percentage of Participants Categorized by Tumor Sample Type (Paraffin-embedded Tissue Blocks, Paraffin Block Slides, Cytology Slides, or Other)(Day 1)
- Percentage of Participants With Vascular Invasion(Day 1)
- Percentage of Participants Categorized by Tumor Sample Source (Primary Tumor or Metastatic Sites)(Day 1)
- Percentage of Participants With Regression(Day 1)
- Percentage of Participants Categorized by Method of DNA Extraction (Cobas® BRAF V600 Mutation Test or Others)(Day 1)
- Percentage of Participants Categorized by Method of BRAF Mutation Testing (Cobas® 4800 BRAF V600 Mutation Test or Others)(Day 1)
- Percentage Participants Categorized by the Percentage of Tumor Cells Referred to the Technique(Day 1)
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