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

NCT ID: NCT01960634

Last Updated: 2015-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stage IV Skin Melanoma

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Grupo Español Multidisciplinar de Melanoma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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María González Cao, MD

Role: STUDY_DIRECTOR

Hospital Universitario Quirón Dexeus

Locations

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Hospital Infanta Cristina

Madrid, Badajoz, Spain

Site Status

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Site Status

Hospital del Mar

Barcelona, Barcelona, Spain

Site Status

Hospital Universitario Quirón Dexeus

Barcelona, Barcelona, Spain

Site Status

Hospital Vall d'Hebron

Barcelona, Barcelona, Spain

Site Status

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Site Status

Hospital Marques de Valdecilla

Santander, Cantabria, Spain

Site Status

Hospital Insular de Gran Canaria

Las Palmas de Gran Canaria, Las Palmas, Spain

Site Status

Hospital Ramón y Cajal

Madrid, Madrid, Spain

Site Status

Hospital Costa del SOl

Marbella, Málaga, Spain

Site Status

Hospital Virgen de la Salud

Toledo, Toledo, Spain

Site Status

Fundación Instituto Valenciano de Oncología

Valencia, Valencia, Spain

Site Status

Hospital Miguel Servet

Zaragoza, Zaragoza, Spain

Site Status

Countries

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Spain

Other Identifiers

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GEM-1304

Identifier Type: OTHER

Identifier Source: secondary_id

GEM-1304

Identifier Type: -

Identifier Source: org_study_id

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