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

May 4, 2015 updated by: Grupo Español Multidisciplinar de 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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • Hospital Del Mar
      • Barcelona, Spain, 08035
        • Hospital Vall d'hebrón
      • Barcelona, Spain, 08028
        • Hospital Universitario Quirón Dexeus
      • Barcelona, Spain, 08041
        • Hospital de La Santa Creu i Sant Pau
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal
      • Santander, Spain, 39008
        • Hospital Marqués de Valdecilla
      • Toledo, Spain
        • Hospital Virgen de la Salud
      • Valencia, Spain, 46009
        • Fundación Instituto Valenciano de Oncología
      • Zaragoza, Spain, 50009
        • Hospital Miguel Servet
    • Badajoz
      • Madrid, Badajoz, Spain, 06080
        • Hospital Infanta Cristina
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Germans Trías i Pujol
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35001
        • Hospital Insular de Gran Canaria
    • Málaga
      • Marbella, Málaga, Spain, 29603
        • Hospital Costa del Sol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with histologically confirmed melanoma and BRAF V600 mutation

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of patient in which BRAF V600 in blood samples is present/absent
Time Frame: two years
two years

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of patients with BRAFV600 present in tumor sample vs blood sample
Time Frame: two years
two years

Other Outcome Measures

Outcome Measure
Time Frame
BRAF V600 blood levels and illness evolution
Time Frame: two years
two years
NRAS and p61BRAFFV600 serum levels and clinic evolution
Time Frame: two years
two years
BRAFV600 blood levels vs progression-free survival
Time Frame: two years
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo Español Multidisciplinar de Melanoma

Investigators

  • Study Director: María González Cao, MD, Hospital Universitario Quirón Dexeus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

October 7, 2013

First Submitted That Met QC Criteria

October 9, 2013

First Posted (Estimate)

October 10, 2013

Study Record Updates

Last Update Posted (Estimate)

May 5, 2015

Last Update Submitted That Met QC Criteria

May 4, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEM-1304 (Other Identifier: Sponsor)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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