Molecular Characterization of Advanced Stage Melanoma by Blood Sampling
MELCIRC
1 other identifier
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2016
Longer than P75 for not_applicable
1 active site
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
Study Start
First participant enrolled
January 14, 2016
CompletedFirst Submitted
Initial submission to the registry
August 8, 2016
CompletedFirst Posted
Study publicly available on registry
August 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedJanuary 21, 2026
September 1, 2022
4 years
August 8, 2016
January 19, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
patients with metastatic melanoma
EXPERIMENTALpatients with metastatic melanoma (stage III unresectable or stage IV)
Interventions
Blood sample to realize molecular characterization of melanoma
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \- Metastatic tumor whose origin is doubtful (uncertain melanoma)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CHU de Reimslead
Study Sites (1)
Chu de Reims
Reims, 51092, France
Related Publications (1)
Beaudoux O, Riffaud L, Barbe C, Grange F. Prognostic factors and incidence of primary mucosal melanoma: a population-based study in France. Eur J Dermatol. 2018 Oct 1;28(5):654-660. doi: 10.1684/ejd.2018.3398.
PMID: 30378540RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2016
First Posted
August 11, 2016
Study Start
January 14, 2016
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
January 21, 2026
Record last verified: 2022-09