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CompletedNCT02133222AMMAMUpdated Mar 31, 2026

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

An interventional study of blood sample in Metastatic (Stage IV) Melanoma, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-31.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Metastatic (Stage IV) Melanoma
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In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 883 are open to participants now.

This study's enrollment of 22 is below the median of 54 across 2,765 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    Metastatic (stage IV) melanoma

    Procedure: blood sample

Interventions

  • Procedureblood sample
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What researchers measure

Primary outcomes

  1. Response to treatment (MRI, Scanner)

    Comparison between first day and third months

    Time frame: at three months

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Study locations

1 site
  • CHU de Nice
    Nice, 06000, France
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References and documents

Publications

  • Long-Mira E, Ilie M, Chamorey E, Leduff-Blanc F, Montaudie H, Tanga V, Allegra M, Lespinet-Fabre V, Bordone O, Bonnetaud C, Schiappa R, Butori C, Bence C, Lacour JP, Hofman V, Hofman P. Monitoring BRAF and NRAS mutations with cell-free circulating tumor DNA from metastatic melanoma patients. Oncotarget. 2018 Nov 16;9(90):36238-36249. doi: 10.18632/oncotarget.26343. eCollection 2018 Nov 16. PubMed 30546839 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02133222
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
May 7, 2014
Start date
May 2014
Primary completion
Jul 2014
Completion
Aug 2016
Last update
Mar 31, 2026

Study contacts

Elodie LONG-MIRA, PH
principal investigator · Centre Hospitalier Universitaire de Nice

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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