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NCT02862743 Clinical Trial

Molecular Characterization of Advanced Stage Melanoma by Blood Sampling

Metastatic Melanoma Clinical Trial

— MELCIRC  

Official title:
Molecular Characterization of Advanced Stage Melanoma by Blood Sampling

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02862743
Other study ID # PO15097*
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 14, 2016
Est. completion date December 31, 2019

Study information
Verified date September 2022
Source CHU de Reims
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• patients with metastatic melanoma
Blood sample to realize molecular characterization of melanoma

Locations
Country Name City State
France Chu de Reims Reims

Sponsors (1)
Lead Sponsor Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic sensitivity of a panel of biomarker on the circulating tumor DNA from peripheral blood Number of patients for which a circulating tumor DNA is detected (positivity of at least one marker of the panel) Day 0
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