Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06605443
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Precision Medicine for LGCMN and Melanoma 2
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Precision Medicine for LGCMN and Melanoma 1 Precis-mel 2
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Precis-mel 2
Brief Summary:
The primary objective is to evaluate the possibility of using minimally and non-invasive technologies skin patch and breath analyzer based on the detection of volatile organic compounds VOCs for the early identification of metastases The secondary objective is to evaluate the usability of these technologies in the follow up of high-risk melanoma patients
Detailed Description:
This is a unicentric national prospective observational study aimed at evaluating the use of two devices skin patch and breath analyzer for the non or minimally invasive diagnosis of metastatic melanoma with a total duration of 24 months The study will be based on the obtention of different patterns of volatile organic compounds using the aforementioned devices for melanoma patients with and without metastasis The results will be compared with the standard procedures for the detection of metastatic melanoma standard imaging techniques such as PET MRI etc and correlated with standard prognostic biomarkers cfDNA mutations in BRAF NRAS etc obtained using liquid biopsy
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