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

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

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

Study Overview

• Status: Completed
• Conditions: Metastatic Cancers

• Study Type: Observational
• Enrollment (Actual): 264

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
  • Barcelona, Spain, 08003
  • Barcelona, Spain, 08035
  • Barcelona, Spain, 08916
  • Burgos, Spain, 09006
  • Caceres, Spain, 10003
  • Castellon, Spain, 12002
  • Girona, Spain, 17007
  • Granada, Spain, 18014
  • Lerida, Spain, 25198
  • Madrid, Spain, 28046
  • Madrid, Spain, 28034
  • Madrid, Spain, 28041
  • Madrid, Spain, 28007
  • Madrid, Spain, 28002
  • Malaga, Spain, 29010
  • Murcia, Spain, 30120
  • Salamanca, Spain, 37007
  • Sevilla, Spain, 41009
  • Toledo, Spain, 45004
  • Valencia, Spain, 46017
  • Valencia, Spain, 41014
  • Zaragoza, Spain, 50009
  • Asturias
    • Oviedo, Asturias, Spain, 33011
  • Cadiz
    • Jerez de La Frontera, Cadiz, Spain, 11407
  • Cantabria
    • Santander, Cantabria, Spain, 39008
  • Guipuzcoa
    • Donostia, Guipuzcoa, Spain, 20080
  • Islas Baleares
    • Palma de Mallorca, Islas Baleares, Spain, 07198
  • LA Coruña
    • A Coruña, LA Coruña, Spain, 15006
  • Murcia
    • Cartagena (Murcia), Murcia, Spain, 30202
  • Navarra
    • Pamplona, Navarra, Spain, 31008
  • Tenerife
    • Santa Cruz de Tenerife, Tenerife, Spain, 38010
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48013

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants diagnosed with metastatic melanoma who have valid samples for BRAF mutation testing and give their informed consent will be included in this trial.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Metastatic melanoma; 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?

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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: November 20, 2015
• First Submitted That Met QC Criteria: January 21, 2016
• First Posted (Estimated): January 26, 2016

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 29, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Metastatic melanoma; V600 BRAF mutation
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: ML30089