Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06605417
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Understanding the Transition from Normal Melanocytes to Nevus to Melanoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Understanding the Transition from Normal Melanocytes to Nevus to Melanoma NevustoMel
Status:
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:
NevustoMel
Brief Summary:
The primary objective of this study is to identify the molecular identity profiles of all cellular states that characterize the progression from benign nevi to malignant melanoma in CAYA patients with LGCMN The secondary objectives are
To longitudinally characterize the cell-free DNA cfDNA from CAYA patients
To improve the early diagnosis and treatments for intermediate conditions such as LGCMN through evidence-based interpretation of personal risk from endogenous or exogenous sources
To test pre-clinical strategies to best model and improve patient response
To longitudinally characterize the cell-free DNA cfDNA from CAYA patients
To improve the early diagnosis and treatments for intermediate conditions such as LGCMN through evidence-based interpretation of personal risk from endogenous or exogenous sources
To test pre-clinical strategies to best model and improve patient response
Detailed Description:
NevustoMel is an international multicentric retrospective cohort study with molecular and experimental design It will involve the genomic characterization of cell-free DNA and affected tissues from patients Methylomics and single-cell multi-omics will be used to identify co-existing molecular transcriptional and epigenomic states at single-cell level and will be generated from affected tissues These results will be exploited using machine learning-assisted integration of multi-modal transcriptomics epigenomics and spatial information Integrated analyses of single-nucleus RNA sequencing from a selection of frozen tissues and spatial transcriptomics on formalin-fixed paraffin-embedded samples will allow the comparison of the findings to ground-state Human Developmental Cell Atlas data Distinctions will be validated either with in situ hybridization such as RNA sequencing or immunostaining on test cohort tissues These results will be complemented with in vitro functional analyses high throughput sequencing and bioinformatic analyses
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