Ignite Creation Date:
2024-05-06 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 12:43 PM
Study NCT ID:
NCT03493230
Status:
UNKNOWN
Last Update Posted:
2018-04-12
First Post:
2018-03-26
Brief Title:
Detection of Plasmatic Cell-free BRAF and NRAS Mutations a New Tool for Monitoring Patients With Metastatic Malignant Melanoma Treated With Targeted Therapies or Immunotherapy MALT
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Centre Hospitalier Universitaire de Nice
Study Overview
Official Title:
Detection of Plasmatic Cell-free BRAF and NRAS Mutations a New Tool for Monitoring Patients With Metastatic Malignant Melanoma Treated With Targeted Therapies or Immunotherapy MALT
Status:
UNKNOWN
Status Verified Date:
2018-03
Last Known Status:
NOT_YET_RECRUITING
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:
MALT
Brief Summary:
The main objective of this project is to perform a longitudinal monitoring of BRAF and NRAS cell-free DNA in a large cohort of metastatic melanomas patients before treatment and during the follow-up Results will be compared with clinical data as imaging based on RECIST criteria and the activity of lactate dehydrogenase in serum LDH
Detailed Description:
During a consultation of follow-up for an advanced malignant melanoma stage IIIb or IIIC or IV an investigator presents the study to the patient and give him the note of information and the informed consent
The patient can benefit from a reflexion period of of 7 days
In case of agreement a first blood draw will take place before initiation of any treatment Between D15 and D30 a second blood draw will be taken Then a blood draw will be necessary every two months until recurrence or progression of the disease for a maximum of 22 months
The patient can benefit from a reflexion period of of 7 days
In case of agreement a first blood draw will take place before initiation of any treatment Between D15 and D30 a second blood draw will be taken Then a blood draw will be necessary every two months until recurrence or progression of the disease for a maximum of 22 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None