Ignite Creation Date:
2024-05-06 @ 8:57 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02862743
Status:
COMPLETED
Last Update Posted:
2022-09-19
First Post:
2016-08-08
Brief Title:
Molecular Characterization of Advanced Stage Melanoma by Blood Sampling
Sponsor:
CHU de Reims
Organization:
CHU de Reims
Study Overview
Official Title:
Molecular Characterization of Advanced Stage Melanoma by Blood Sampling
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MELCIRC
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 lInstitut 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None