Clinical trial NCT02663232: Study to Analyze Mutations in V600 BRAF Oncogen in Participants With Metastatic Melanoma
Official title: Epidemiological Study of V600 BRAF Mutation in Spanish Patients Diagnosed With Metastatic Melanoma: ABSOLUT-BRAF Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Cancers
Keywords: V600 BRAF mutation
Metastatic melanoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-01-26
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With V600 BRAF Mutation Status
timeFrame: Day 1
Secondary outcomes:
measure: Percentage of Participants Categorized by Melanoma Stage
timeFrame: Day 1
measure: Percentage of Participants With Family History of Melanoma
timeFrame: Day 1
measure: Percentage of Participants With Sun Exposure
timeFrame: Day 1
measure: Percentage of Participants Categorized by Primary Tumor Location
timeFrame: Day 1
measure: Percentage of Participants Categorized By LDH Level
timeFrame: Day 1
measure: Median Time Since Diagnosis of Melanoma
timeFrame: Day 1
measure: Percentage of Participants Categorized by Tumor Sample Source (Primary Tumor or Metastatic Sites)
timeFrame: Day 1
measure: Percentage of Participants Categorized by Tumor Sample Type (Paraffin-embedded Tissue Blocks, Paraffin Block Slides, Cytology Slides, or Other)
timeFrame: Day 1
measure: Percentage of Participants Categorized by Method of Fixation (Buffered Formalin or Others)
timeFrame: Day 1
measure: Percentage of Participants Categorized by Breslow Thickness
timeFrame: Day 1
measure: Percentage of Participants With Ulceration
timeFrame: Day 1
measure: Percentage of Participants With Regression
timeFrame: Day 1
measure: Percentage of Participants With Vascular Invasion
timeFrame: Day 1
measure: Percentage of Participants Categorized by Method of DNA Extraction (Cobas® BRAF V600 Mutation Test or Others)
timeFrame: Day 1
measure: Percentage of Participants Categorized by Method of BRAF Mutation Testing (Cobas® 4800 BRAF V600 Mutation Test or Others)
timeFrame: Day 1
measure: Percentage Participants Categorized by the Percentage of Tumor Cells Referred to the Technique
timeFrame: Day 1
measure: Percentage of Participants With Adequate Quality/Quantity of Tumor Sample
timeFrame: Day 1
Other outcomes:
Locations:
city: Oviedo
country: Spain
state: Asturias
city: Jerez de La Frontera
country: Spain
state: Cadiz
city: Santander
country: Spain
state: Cantabria
city: Donostia
country: Spain
state: Guipuzcoa
city: Palma de Mallorca
country: Spain
state: Islas Baleares
city: A Coruña
country: Spain
state: LA Coruña
city: Cartagena (Murcia)
country: Spain
state: Murcia
city: Pamplona
country: Spain
state: Navarra
city: Santa Cruz de Tenerife
country: Spain
state: Tenerife
city: Bilbao
country: Spain
state: Vizcaya
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Burgos
country: Spain
city: Caceres
country: Spain
city: Castellon
country: Spain
city: Girona
country: Spain
city: Granada
country: Spain
city: Lerida
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Murcia
country: Spain
city: Salamanca
country: Spain
city: Sevilla
country: Spain
city: Toledo
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Zaragoza
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: