Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06602648
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
MELCAYA - Novel Health Care Strategies for Melanoma in Children Adolescents and Young Adults - Work Package 3 WP3
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Novel Health Care Strategies for Melanoma in Children Adolescents and Young Adults Histological Computational and Molecular Pathology for Improved Diagnosis Mol-Mel Work Package 3 WP3
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:
Mol-Mel
Brief Summary:
The aim of this study is to investigate a type of skin cancer also known as melanoma in children adolescents and young adults who will be referred to as CAYA patients in this project The need for this study arises because this disease in CAYA patients is still poorly understood due to its rarity in individuals under 30 years old This often leads to difficulties in assessing its severity and consequently in deciding on the necessary treatments to ensure the patientampamp39s recovery The goal of this study is to examine melanoma in CAYA patients in order to gather the information needed to provide better diagnoses for affected patients and as a result select appropriate treatments to fight the disease and promote the patientampamp39s full recovery Additionally the data collected will be used to create a Pan-European online platform that will allow doctors across the European Union to consult the obtained data and collaborate on particularly complex melanoma cases always with the aim of ensuring the patientampamp39s full recovery in the shortest possible time
Detailed Description:
The Mol-Mel study will focus on different tasks and for each task different investigations will be carried out
Standardization and tissue quality control The quality of the samples will then be determined using hematoxylin ampamp eosin HE-staining If any quality issue is detected feedback will be sent to the clinical center responsible for providing the sample
Histopathology ampamp computational pathology Melanoma samples will undergo a central pathology review and analysis of conventional prognostic staging parameters Diagnostically challenging neoplasms will be included in an inter-observer agreement carried out by different pathologistMelanoma samples will also be charactered by single and multi-plex IHC in whole sections and tissue microarrays TMA and subjected to automated digital quantification Spatial proteomics by automated ultra-high content imagingMACSima Imaging Cyclic Staining MICS technology enables simultaneous analysis of hundreds of marker antigens on a single sample Hundreds of antigens for single sample will be analysed via Automated ultra-high content imagingMACSima Imaging Cyclic Staining MICS that will be performed on the novel automated ultra-high content imaging platform MACSimaTM Miltenyi Biotec
Comprehensive somatic transcriptional and DNA methylation landscape and data integration DNA and RNA will be extracted by FFPE melanoma samples and characterized using whole-exome sequencing WES single nucleotide polymorphism SNP and RNA sequencing RNAseq arrays on matched tumornormal pairs of samples Then recurrent somatic aberrations DNA methylation subclasses and patterns of tumor evolution will be characterized
Pan-European digital second opinion platform this last task will focus on creating a pan-european second opinion platofrom in order to facilitate standardization of melanoma diagnosis and to share knowledge about biomarkers algorithms and subtype classification
Standardization and tissue quality control The quality of the samples will then be determined using hematoxylin ampamp eosin HE-staining If any quality issue is detected feedback will be sent to the clinical center responsible for providing the sample
Histopathology ampamp computational pathology Melanoma samples will undergo a central pathology review and analysis of conventional prognostic staging parameters Diagnostically challenging neoplasms will be included in an inter-observer agreement carried out by different pathologistMelanoma samples will also be charactered by single and multi-plex IHC in whole sections and tissue microarrays TMA and subjected to automated digital quantification Spatial proteomics by automated ultra-high content imagingMACSima Imaging Cyclic Staining MICS technology enables simultaneous analysis of hundreds of marker antigens on a single sample Hundreds of antigens for single sample will be analysed via Automated ultra-high content imagingMACSima Imaging Cyclic Staining MICS that will be performed on the novel automated ultra-high content imaging platform MACSimaTM Miltenyi Biotec
Comprehensive somatic transcriptional and DNA methylation landscape and data integration DNA and RNA will be extracted by FFPE melanoma samples and characterized using whole-exome sequencing WES single nucleotide polymorphism SNP and RNA sequencing RNAseq arrays on matched tumornormal pairs of samples Then recurrent somatic aberrations DNA methylation subclasses and patterns of tumor evolution will be characterized
Pan-European digital second opinion platform this last task will focus on creating a pan-european second opinion platofrom in order to facilitate standardization of melanoma diagnosis and to share knowledge about biomarkers algorithms and subtype classification
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