Molecular Characterization of Advanced Stage Melanoma by Blood Sampling (MELCIRC)
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|ClinicalTrials.gov Identifier: NCT02862743|
Recruitment Status : Recruiting
First Posted : August 11, 2016
Last Update Posted : October 17, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Melanoma||Other: patients with metastatic melanoma||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Molecular Characterization of Advanced Stage Melanoma by Blood Sampling|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||April 2019|
Experimental: patients with metastatic melanoma
patients with metastatic melanoma (stage III unresectable or stage IV)
Other: patients with metastatic melanoma
Blood sample to realize molecular characterization of melanoma
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02862743
|Contact: Florent GRANGEemail@example.com|
|Chu de Reims||Recruiting|
|Reims, France, 51092|
|Contact: Florent GRANGE firstname.lastname@example.org|