NCT03493230

Brief Summary

The main objective of this project is to perform a longitudinal monitoring of BRAF and NRAS cell-free DNA in a large cohort of metastatic melanomas patients before treatment and during the follow-up. Results will be compared with clinical data as imaging (based on RECIST criteria) and the activity of lactate dehydrogenase in serum (LDH).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 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

March 26, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 10, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

April 24, 2018

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2022

Completed
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

4.5 years

First QC Date

March 26, 2018

Last Update Submit

March 18, 2025

Conditions

Malignant Melanoma Stage IVMalignant Melanoma Stage III

Outcome Measures

Primary Outcomes (2)

  • Quantify plasmatic BRAF and NRAS mutation determine by PCR digitale in µg/ml before treatment

    Day 0

  • Study the longitudinal monitoring of cell-free the kinetics of the plasma mutation of BRAF and NRAS mutation in µg/ml and comparing them with imaging (based on RECIST criteria) and with the activity of the lactate dehydrogenase in serum ( LDH) in U/l .

    Month 24

Secondary Outcomes (2)

  • Compare the results obtained by PCR digitale from the cell-free with the results on FFPE tissue samples

    Month 24

  • Identify genomic alterations and mutations of resistances in a restricted subgroup of patient by New Generation Sequencing analysis

    Month 24

Study Arms (1)

Patient with malignant melanoma

EXPERIMENTAL

Patient with advanced or metastatic malignant melanoma (stage IIIB inoperable or IIIC or stage IV) will have a first blood test before any treatment, then at day 15 or 30 after initiation of therapy, and every two months until recurrence or progression for a maximum of 22 months.

Biological: quantification of BRAF and NRAS mutation

Interventions

quantification of BRAF and NRAS mutationBIOLOGICAL

Quantification of cell-free BRAF and NRAS mutations with digital PCR

Patient with malignant melanoma

Eligibility Criteria

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

You may qualify if:

  • Patients in metastatic situation for a malignant melanoma inoperable stage IIIB or IIIC or stage IV
  • In first line of treatment by a targeted therapy (only or in association) or immunotherapy
  • Every histological types of cutaneous or mucous malignant melanoma (excepted choroid melanomas)
  • The tumor must be mutates for BRAF or NRAS
  • The mutation status must have been realized in the Laboratory Pathology Clinical and Experimental (LPCE) of the CHU de Nice analysis of the status on-site metastatic mutational and/or primitive tumor must
  • Membership or beneficiary of the national insurance scheme

You may not qualify if:

  • Histories of cancer or other synchronous cancer
  • Pregnant, breast-feeding Women. A pregnancy test will be practiced to the women old enough to procreate.
  • Vulnerable People: adults under guardianship, patients deprived of freedom, minor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

nice University hospital

Nice, 06000, France

Location

Related Publications (3)

  • Bahadoran P, Allegra M, Le Duff F, Long-Mira E, Hofman P, Giacchero D, Passeron T, Lacour JP, Ballotti R. Major clinical response to a BRAF inhibitor in a patient with a BRAF L597R-mutated melanoma. J Clin Oncol. 2013 Jul 1;31(19):e324-6. doi: 10.1200/JCO.2012.46.1061. Epub 2013 May 28. No abstract available.

    PMID: 23715574BACKGROUND

  • de Vries E, Bray FI, Coebergh JW, Parkin DM. Changing epidemiology of malignant cutaneous melanoma in Europe 1953-1997: rising trends in incidence and mortality but recent stabilizations in western Europe and decreases in Scandinavia. Int J Cancer. 2003 Oct 20;107(1):119-26. doi: 10.1002/ijc.11360.

    PMID: 12925966BACKGROUND

  • Dhillon AS, Hagan S, Rath O, Kolch W. MAP kinase signalling pathways in cancer. Oncogene. 2007 May 14;26(22):3279-90. doi: 10.1038/sj.onc.1210421.

    PMID: 17496922BACKGROUND

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Elodie LONG-MIRA, MD

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 26, 2018

First Posted

April 10, 2018

Study Start

April 24, 2018

Primary Completion

November 8, 2022

Study Completion

November 8, 2022

Last Updated

March 20, 2025

Record last verified: 2025-03

Locations

FR(1)