Circulating Cell-free DNA in Metastatic Melanoma Patient: Mutational Analyses in Consecutive Measurement Before and After Chemotherapy

Not Applicable

Completed

• Conditions: Metastatic (Stage IV) Melanoma
• Interventions: Procedure: blood sample

• Registration Number: NCT02133222
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

Therapies that target specific molecules markedly inhibit cancer growth in several malignancies, and provide valuable strategies for the treatment of advanced melanoma. In recent years, BRAF and KIT have become established therapeutic targets in melanoma patients showing activating mutations in these oncogenes. However, it is crucial that genetic mutations present in the melanoma lesions are identified if the investigators are to design tailormade therapies for individual patients. The tumour genotypes that determine the selection of molecular-targeted therapies are usually identified in primary tumours; however, primary tumours are not always representative of metastases. Circulating free DNA may be a source of valuable information because it can be obtained via routine blood sampling, it provides real-time information about a patient's current disease state, and it allows monitoring and molecular characterization before and after chemotherapy. The aim of the study is to determine the mutational status in circulating DNA in melanoma metastatic patients, with the Sequenom Mass Array, a next generation sequencing technology. Results obtained before and after treatment will be compared with the primary tumor genotype.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-30
• Study Start: 2014-05
• Study First Submitted QC: 2014-05-06
• Study First Posted: 2014-05-07
• Primary Completion: 2014-07
• Status Verified: 2016-03
• Study Completion: 2016-08
• Last Update Submitted: 2016-10-20
• Last Update Posted: 2016-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Age>18 years
• Surgical biopsy for histologic diagnostic
• All melanoma subtypes
• Known genotype BRAF V600
• Affiliation social security
• Consent form signed

Exclusion Criteria

• Patient with histories of cancer or the other synchronous cancer
• Pregnant women
• Breast-feeding women
• Vulnerable patients: major under guardianship; patient deprived of its rights

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metastatic (stage IV) melanoma	blood sample	-

Primary Outcome Measures

Name	Time	Method
Response to treatment (MRI, Scanner)	at three months	Comparison between first day and third months

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, France