Molecular Characterization of Advanced Stage Melanoma by Blood Sampling (MELCIRC)
Primary Purpose
Metastatic Melanoma
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
patients with metastatic melanoma
Sponsored by
About this trial
This is an interventional basic science trial for Metastatic Melanoma
Eligibility Criteria
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)
Sites / Locations
- Chu de Reims
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patients with metastatic melanoma
Arm Description
patients with metastatic melanoma (stage III unresectable or stage IV)
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02862743
Brief Title
Molecular Characterization of Advanced Stage Melanoma by Blood Sampling
Acronym
MELCIRC
Official Title
Molecular Characterization of Advanced Stage Melanoma by Blood Sampling
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 14, 2016 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
5. Study Description
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.
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Melanoma
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients with metastatic melanoma
Arm Type
Experimental
Arm Description
patients with metastatic melanoma (stage III unresectable or stage IV)
Intervention Type
Other
Intervention Name(s)
patients with metastatic melanoma
Intervention Description
Blood sample to realize molecular characterization of melanoma
Primary Outcome Measure Information:
Title
Diagnostic sensitivity of a panel of biomarker on the circulating tumor DNA from peripheral blood
Description
Number of patients for which a circulating tumor DNA is detected (positivity of at least one marker of the panel)
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Chu de Reims
City
Reims
ZIP/Postal Code
51092
Country
France
12. IPD Sharing Statement
Learn more about this trial
Molecular Characterization of Advanced Stage Melanoma by Blood Sampling
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