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

Stage IV Skin Melanoma Clinical Trial

— BRAFV600  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01960634
• Other study ID #: GEM-1304
• Secondary ID: GEM-1304
• Status: Completed
• Phase: N/A
• First received: October 7, 2013
• Last updated: May 4, 2015
• Start date: April 2013
• Est. completion date: May 2015

Study information

• Verified date: April 2015
• Source: Grupo Español Multidisciplinar de Melanoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Melanoma
• Stage IV Skin Melanoma

Locations

Country	Name	City	State
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitario Quirón Dexeus	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital Insular de Gran Canaria	Las Palmas de Gran Canaria	Las Palmas
Spain	Hospital Infanta Cristina	Madrid	Badajoz
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Costa del SOl	Marbella	Málaga
Spain	Hospital Marques de Valdecilla	Santander
Spain	Hospital Virgen de la Salud	Toledo
Spain	Fundación Instituto Valenciano de Oncología	Valencia
Spain	Hospital Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Español Multidisciplinar de Melanoma

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	BRAF V600 blood levels and illness evolution		two years	No
Other	NRAS and p61BRAFFV600 serum levels and clinic evolution		two years	No
Other	BRAFV600 blood levels vs progression-free survival		two years	No
Primary	Rate of patient in which BRAF V600 in blood samples is present/absent		two years	No
Secondary	Rate of patients with BRAFV600 present in tumor sample vs blood sample		two years	No