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

Metastatic (Stage IV) Melanoma Clinical Trial

— AMMAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02133222
• Other study ID #: 13-AOI-04
• Status: Completed
• Phase: N/A
• First received: April 30, 2014
• Last updated: October 20, 2016
• Start date: May 2014
• Est. completion date: August 2016

Study information

• Verified date: March 2016
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 2016
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Melanoma
• Metastatic (Stage IV) Melanoma

Intervention

Procedure:
• blood sample

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to treatment (MRI, Scanner)	Comparison between first day and third months	at three months	No