Translational Study for BRAFV600 Serum and Plasma Determination in Patients With BRAFV600 Metastatic Melanoma
BRAFV600
1 other identifier
observational
58
1 country
13
Brief Summary
This is a multi-centric translational study with biological samples collection. The aim of this study is to validate a method to detect BRAFV600 in blood samples. Samples: Blood from patients with BRAFV600 metastatic melanoma collected following standard medical practice. The treatment is not the aim of the study. Patients can be treated either with specific or no-specific drug.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2013
Typical duration for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 7, 2013
CompletedFirst Posted
Study publicly available on registry
October 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedMay 5, 2015
April 1, 2015
2.1 years
October 7, 2013
May 4, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of patient in which BRAF V600 in blood samples is present/absent
two years
Secondary Outcomes (1)
Rate of patients with BRAFV600 present in tumor sample vs blood sample
two years
Other Outcomes (3)
BRAF V600 blood levels and illness evolution
two years
NRAS and p61BRAFFV600 serum levels and clinic evolution
two years
BRAFV600 blood levels vs progression-free survival
two years
Eligibility Criteria
Patients with histologically confirmed melanoma and BRAF V600 mutation
You may qualify if:
- Confirmed diagnosis of melanoma and BRAFV600
- Signed Informed Consent Form
- Unresectable phase III or phase IV melanoma
- The patients should be starting a treatment for melanoma (either first line or subsequent lines)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Hospital Infanta Cristina
Madrid, Badajoz, 06080, Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital del Mar
Barcelona, Barcelona, 08003, Spain
Hospital Universitario Quirón Dexeus
Barcelona, Barcelona, 08028, Spain
Hospital Vall d'Hebron
Barcelona, Barcelona, 08035, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08041, Spain
Hospital Marques de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Insular de Gran Canaria
Las Palmas de Gran Canaria, Las Palmas, 35001, Spain
Hospital Ramón y Cajal
Madrid, Madrid, 28034, Spain
Hospital Costa del SOl
Marbella, Málaga, 29603, Spain
Hospital Virgen de la Salud
Toledo, Toledo, Spain
Fundación Instituto Valenciano de Oncología
Valencia, Valencia, 46009, Spain
Hospital Miguel Servet
Zaragoza, Zaragoza, 50009, Spain
Biospecimen
Serum and Plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
María González Cao, MD
Hospital Universitario Quirón Dexeus
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2013
First Posted
October 10, 2013
Study Start
April 1, 2013
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
May 5, 2015
Record last verified: 2015-04