- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02133222
Circulating Cell-free DNA in Metastatic Melanoma Patient: Mutational Analyses in Consecutive Measurement Before and After Chemotherapy (AMMAM)
March 26, 2026 updated by: Centre Hospitalier Universitaire de Nice
Circulating Cell-free DNA in Metastatic Melanoma Patient: Mutational Analyses in Consecutive Measurement Before and After Chemotherapy.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nice, France, 06000
- CHU de Nice
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Metastatic (stage IV) melanoma
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Response to treatment (MRI, Scanner)
Time Frame: at three months
|
Comparison between first day and third months
|
at three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Elodie LONG-MIRA, PH, Centre Hospitalier Universitaire de Nice
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2014
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
April 30, 2014
First Submitted That Met QC Criteria
May 6, 2014
First Posted (Estimated)
May 7, 2014
Study Record Updates
Last Update Posted (Actual)
March 31, 2026
Last Update Submitted That Met QC Criteria
March 26, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Site
- Neoplasms
- Neoplasms by Histologic Type
- Neoplastic Processes
- Skin Diseases
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Skin Neoplasms
- Pathological Conditions, Signs and Symptoms
- Skin and Connective Tissue Diseases
- Neoplasm Metastasis
- Melanoma
- Investigative Techniques
- Specimen Handling
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Punctures
- Surgical Procedures, Operative
- Blood Specimen Collection
Other Study ID Numbers
- 13-AOI-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.