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

Completed

• Conditions: Metastatic Cancers

• Registration Number: NCT02663232
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Study First Submitted: 2015-11-20
• Study First Submitted QC: 2016-01-21
• Study First Posted: 2016-01-26
• Results First Submitted: 2016-03-03
• Results First Submitted QC: 2016-03-03
• Results First Posted: 2016-04-05
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-29
• Last Update Posted: 2023-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

• Valid tumor samples from participants diagnosed with Stage IIIc or IV melanoma
• Written informed consent granted

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Exclusion Criteria

• Do not fulfill one or more inclusion criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With V600 BRAF Mutation Status	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Categorized by Method of BRAF Mutation Testing (Cobas® 4800 BRAF V600 Mutation Test or Others)	Day 1
Percentage of Participants With Adequate Quality/Quantity of Tumor Sample	Day 1
Percentage of Participants With Sun Exposure	Day 1	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.
Percentage of Participants Categorized By LDH Level	Day 1	Normal LDH levels range from 140 units per liter (U/L) to 280 U/L.
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	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.
Median Time Since Diagnosis of Melanoma	Day 1	Median time from the diagnosis of primary melanoma to advanced disease was determined in years.
Percentage of Participants Categorized by Breslow Thickness	Day 1	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.
Percentage of Participants With Ulceration	Day 1
Percentage of Participants Categorized by Melanoma Stage	Day 1	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.
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	Vascular invasion is defined as the appearance of cancer cells in the lymphatic and blood streams.
Percentage of Participants Categorized by Tumor Sample Source (Primary Tumor or Metastatic Sites)	Day 1
Percentage of Participants With Regression	Day 1	Regression in melanoma is the replacement of tumor tissue with fibrosis, degenerated melanoma cells, lymphocytic proliferation, and telangiectasia formation.
Percentage of Participants Categorized by Method of DNA Extraction (Cobas® BRAF V600 Mutation Test or Others)	Day 1
Percentage Participants Categorized by the Percentage of Tumor Cells Referred to the Technique	Day 1	The samples were classified based on the percentage of tumor cells referred to the technique as follows: \<60 percent (%), 60-80%, \>80% and Unknown.