This is a national, multicenter, cross-sectional epidemiological study in adult Spanish participants diagnosed with advanced or metastatic melanoma.
Study Type
OBSERVATIONAL
Enrollment
264
Unnamed facility
Palma de Mallorca, Balearic Islands, Spain
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.
Time frame: Day 1
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.
Time frame: Day 1
Percentage of Participants With Family History of Melanoma
Time frame: 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.
Time frame: 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.
Time frame: Day 1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Jerez de la Frontera, Cadiz, Spain
Unnamed facility
Santander, Cantabria, Spain
Unnamed facility
Castellon, Castellon, Spain
Unnamed facility
Donostia / San Sebastian, Guipuzcoa, Spain
Unnamed facility
A Coruña, LA Coruña, Spain
Unnamed facility
Cartagena (Murcia), Murcia, Spain
Unnamed facility
Pamplona, Navarre, Spain
Unnamed facility
Oviedo, Principality of Asturias, Spain
Unnamed facility
Santa Cruz de Tenerife, Tenerife, Spain
...and 23 more locations
Percentage of Participants Categorized By LDH Level
Normal LDH levels range from 140 units per liter (U/L) to 280 U/L.
Time frame: Day 1
Median Time Since Diagnosis of Melanoma
Median time from the diagnosis of primary melanoma to advanced disease was determined in years.
Time frame: Day 1
Percentage of Participants Categorized by Tumor Sample Source (Primary Tumor or Metastatic Sites)
Time frame: Day 1
Percentage of Participants Categorized by Tumor Sample Type (Paraffin-embedded Tissue Blocks, Paraffin Block Slides, Cytology Slides, or Other)
Time frame: Day 1
Percentage of Participants Categorized by Method of Fixation (Buffered Formalin or Others)
Time frame: 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.
Time frame: Day 1
Percentage of Participants With Ulceration
Time frame: 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.
Time frame: Day 1
Percentage of Participants With Vascular Invasion
Vascular invasion is defined as the appearance of cancer cells in the lymphatic and blood streams.
Time frame: Day 1
Percentage of Participants Categorized by Method of DNA Extraction (Cobas® BRAF V600 Mutation Test or Others)
Time frame: Day 1
Percentage of Participants Categorized by Method of BRAF Mutation Testing (Cobas® 4800 BRAF V600 Mutation Test or Others)
Time frame: 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.
Time frame: Day 1
Percentage of Participants With Adequate Quality/Quantity of Tumor Sample
Time frame: Day 1