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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01960634

Acronym

BRAFV600

Enrollment

Registered

2013-10-10

Start date

2013-04-30

Completion date

2015-05-31

Last updated

2015-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage IV Skin Melanoma

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame
Rate of patients with BRAFV600 present in tumor sample vs blood sample	two years

Other

Measure	Time frame
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

Countries

Spain

Outcome results