Translational Study for BRAFV600 Serum and Plasma Determination in Patients With BRAFV600 Metastatic Melanoma

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.

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Key information

Conditions

Stage IV Skin Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Infanta Cristina, Madrid, Badajoz, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)

Treatment and study plan

Primary outcomes

Rate of patient in which BRAF V600 in blood samples is present/absent

Time frame: two years

Secondary outcomes

Rate of patients with BRAFV600 present in tumor sample vs blood sample

Time frame: two years

Other outcomes

BRAF V600 blood levels and illness evolution

Time frame: two years
NRAS and p61BRAFFV600 serum levels and clinic evolution

Time frame: two years
BRAFV600 blood levels vs progression-free survival

Time frame: two years

Sponsors and collaborators

Lead sponsor

Grupo Español Multidisciplinar de Melanoma

Other

Registry information

Acronym: BRAFV600

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Oct 10, 2013
Registry last updated: May 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed