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
1 other identifier
observational
264
1 country
33
Brief Summary
This is a national, multicenter, cross-sectional epidemiological study in adult Spanish participants diagnosed with advanced or metastatic melanoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2013
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 20, 2015
CompletedFirst Posted
Study publicly available on registry
January 26, 2016
CompletedResults Posted
Study results publicly available
April 5, 2016
CompletedJuly 3, 2023
June 1, 2023
1.3 years
November 20, 2015
March 3, 2016
June 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (17)
Percentage of Participants Categorized by Melanoma Stage
Day 1
Percentage of Participants With Family History of Melanoma
Day 1
Percentage of Participants With Sun Exposure
Day 1
Percentage of Participants Categorized by Primary Tumor Location
Day 1
Percentage of Participants Categorized By LDH Level
Day 1
- +12 more secondary outcomes
Study Arms (1)
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.
Eligibility Criteria
Participants diagnosed with metastatic melanoma who have valid samples for BRAF mutation testing and give their informed consent will be included in this trial.
You may qualify if:
- Valid tumor samples from participants diagnosed with Stage IIIc or IV melanoma
- Written informed consent granted
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Unknown Facility
Palma de Mallorca, Balearic Islands, 07198, Spain
Unknown Facility
Jerez de la Frontera, Cadiz, 11407, Spain
Unknown Facility
Santander, Cantabria, 39008, Spain
Unknown Facility
Castellon, Castellon, 12002, Spain
Unknown Facility
Donostia / San Sebastian, Guipuzcoa, 20080, Spain
Unknown Facility
A Coruña, LA Coruña, 15006, Spain
Unknown Facility
Cartagena (Murcia), Murcia, 30202, Spain
Unknown Facility
Pamplona, Navarre, 31008, Spain
Unknown Facility
Oviedo, Principality of Asturias, 33011, Spain
Unknown Facility
Santa Cruz de Tenerife, Tenerife, 38010, Spain
Unknown Facility
Bilbao, Vizcaya, 48013, Spain
Unknown Facility
Barcelona, 08003, Spain
Unknown Facility
Barcelona, 08035, Spain
Unknown Facility
Barcelona, 08036, Spain
Unknown Facility
Barcelona, 08916, Spain
Unknown Facility
Burgos, 09006, Spain
Unknown Facility
Cáceres, 10003, Spain
Unknown Facility
Girona, 17007, Spain
Unknown Facility
Granada, 18014, Spain
Unknown Facility
Lleida, 25198, Spain
Unknown Facility
Madrid, 28002, Spain
Unknown Facility
Madrid, 28007, Spain
Unknown Facility
Madrid, 28034, Spain
Unknown Facility
Madrid, 28041, Spain
Unknown Facility
Madrid, 28046, Spain
Unknown Facility
Málaga, 29010, Spain
Unknown Facility
Murcia, 30120, Spain
Unknown Facility
Salamanca, 37007, Spain
Unknown Facility
Seville, 41009, Spain
Unknown Facility
Toledo, 45004, Spain
Unknown Facility
Valencia, 41014, Spain
Unknown Facility
Valencia, 46017, Spain
Unknown Facility
Zaragoza, 50009, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2015
First Posted
January 26, 2016
Study Start
June 1, 2013
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
July 3, 2023
Results First Posted
April 5, 2016
Record last verified: 2023-06