Study to Analyze Mutations in V600 BRAF Oncogen in Participants With Metastatic Melanoma

Study Overview
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Brief Summary
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This is a national, multicenter, cross-sectional epidemiological study in adult Spanish participants diagnosed with advanced or metastatic melanoma.

Official Title
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Epidemiological Study of V600 BRAF Mutation in Spanish Patients Diagnosed With Metastatic Melanoma: ABSOLUT-BRAF Study

Conditions
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Metastatic Cancers

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Valid tumor samples from participants diagnosed with Stage IIIc or IV melanoma Written informed consent granted Exclusion Criteria: - Do not fulfill one or more inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Metastatic melanoma<br>Participants with metastatic melanoma who attend their physicians during the 18-month recruitment period and have valid biological samples available for BRAF mutation testing will be included in the study. There will be no intervention in this study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With V600 BRAF Mutation Status | 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. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Categorized by Melanoma Stage | Melanoma stages were categorized (according to American Joint Committee on Cancer [AJCC]) as IIIc (advanced stage of melanoma), M1a (metastases to skin, subcutaneous, or distant lymph nodes, normal lactate dehydrogenase (LDH) level, M1b (lung metastases, normal LDH) and M1c (metastases to all other visceral sites and normal LDH or distant metastases to any site combined with an elevated serum LDH level). Of these Stage IIIc was used as the referral category for comparisons. | Day 1 | 
| Percentage of Participants With Family History of Melanoma |  | Day 1 | 
| Percentage of Participants With Sun Exposure | Data were obtained to classify the population with sun exposure as those with low, intermittent or chronic exposure. For the sub-analysis of low, intermittent and chronic exposure, percentages were calculated based on the population with any sun exposure. | Day 1 | 
| Percentage of Participants Categorized by Primary Tumor Location | Primary tumor location included limbs (upper and lower extremities), trunk, head/neck, mucosa, uveal, acral, other (other than these specified locations), unknown (exact location unknown), and not available. | Day 1 | 
| Percentage of Participants Categorized By LDH Level | Normal LDH levels range from 140 units per liter (U/L) to 280 U/L. | Day 1 | 
| Median Time Since Diagnosis of Melanoma | Median time from the diagnosis of primary melanoma to advanced disease was determined in years. | Day 1 | 
| Percentage of Participants Categorized by Tumor Sample Source (Primary Tumor or Metastatic Sites) |  | 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 Categorized by Method of Fixation (Buffered Formalin or Others) |  | Day 1 | 
| Percentage of Participants Categorized by Breslow Thickness | Breslow thickness is defined as the total vertical height of the melanoma, from the very top (called the granular layer) to the area of deepest penetration in the skin. An instrument called an ocular micrometer is used to measure the thickness of the excised (removed) tumor. In general, the higher the Breslow thickness, the worse the prognosis. The classifications were lesser than or equal to (≤) 1.0 millimeters (mm), 1.01 - 2.0 mm, 2.01 - 4.0 mm, greater than (>) 4.0 mm and Unknown. | Day 1 | 
| Percentage of Participants With Ulceration |  | Day 1 | 
| Percentage of Participants With Regression | Regression in melanoma is the replacement of tumor tissue with fibrosis, degenerated melanoma cells, lymphocytic proliferation, and telangiectasia formation. | Day 1 | 
| Percentage of Participants With Vascular Invasion | Vascular invasion is defined as the appearance of cancer cells in the lymphatic and blood streams. | 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 | The samples were classified based on the percentage of tumor cells referred to the technique as follows: <60 percent (%), 60-80%, >80% and Unknown. | Day 1 | 
| Percentage of Participants With Adequate Quality/Quantity of Tumor Sample |  | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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V600 BRAF mutation, Metastatic melanoma