NCT02133222

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

April 30, 2014

Last Update Submit

March 26, 2026

Conditions

Metastatic (Stage IV) Melanoma

Outcome Measures

Primary Outcomes (1)

  • Response to treatment (MRI, Scanner)

    Comparison between first day and third months

    at three months

Study Arms (1)

Metastatic (stage IV) melanoma

EXPERIMENTAL
Procedure: blood sample

Interventions

blood samplePROCEDURE
Metastatic (stage IV) melanoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, 06000, France

Location

Related Publications (1)

  • 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.

    PMID: 30546839RESULT

MeSH Terms

Conditions

Neoplasm MetastasisMelanoma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Elodie LONG-MIRA, PH

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2014

First Posted

May 7, 2014

Study Start

May 1, 2014

Primary Completion

July 1, 2014

Study Completion

August 1, 2016

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations

FR(1)