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

NCT ID: NCT02133222

Last Updated: 2016-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-08-31

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.

Conditions

Metastatic (Stage IV) Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Metastatic (stage IV) melanoma

Group Type: EXPERIMENTAL

blood sample

Intervention Type: PROCEDURE

Interventions

blood sample

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elodie LONG-MIRA, PH

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

CHU de Nice

Nice, , France

Countries

France

Other Identifiers

13-AOI-04

Identifier Type: -

Identifier Source: org_study_id