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OpenTrials
Completed

NCT Number: NCT02862743

Molecular Characterization of Advanced Stage Melanoma by Blood Sampling

Analysis of somatic mutations in tumors is currently indicated for daily practice in all metastatic melanoma. Actually, this research is limited to the mutation of three biomarkers validated by the l'Institut National du CAncer (INCA): BRAF, NRAS and CKIT. Moreover, in some cases it requires invasive biopsies.

In this context, molecular characterization of a tumor material flowing (circulating tumor DNA and / or circulating tumor cells) could afford to benefit patients in the best conditions of current targeted therapies and future.

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Key information

Conditions

Metastatic Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu de Reims

Reims, 51092, France

About this study

The main objective of this study will be to define the diagnostic sensitivity of a panel of biomarker on the circulating tumor DNA from peripheral blood.

The secondary objectives of this study will be:

  • Study the concordance between mutations in circulating tumor DNA and mutations in tumor tissue - Study the associations between mutational profiles and clinical and histological features of melanoma.
  • Study the prognostic impact on survival of the identified genetic profile from the circulating tumor DNA

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patient with melanoma confirmed histologically
  • patient with metastatic melanoma (stage III unresectable or stage IV)
  • patient consenting to participate to the study
  • patient enrolled in the national healthcare insurance program
  • patient older than 18 years

Exclusion criteria

  • Metastatic tumor whose origin is doubtful (uncertain melanoma)

Treatment and study plan

patients with metastatic melanoma

Other

Blood sample to realize molecular characterization of melanoma

Primary outcomes

  1. Diagnostic sensitivity of a panel of biomarker on the circulating tumor DNA from peripheral blood

    Time frame: Day 0

    Number of patients for which a circulating tumor DNA is detected (positivity of at least one marker of the panel)

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Acronym: MELCIRC

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 11, 2016
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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