Ignite Creation Date:
2024-05-06 @ 7:39 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06080009
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2023-10-08
Brief Title:
Analysis of Molecular Biomarkers in Periocular Adnexal Tumours
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Analysis of Molecular Biomarkers in Periocular Adnexal Tumours
Status:
RECRUITING
Status Verified Date:
2024-02
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:
None
Brief Summary:
The aim of this study is to collect sebaceous carcinomas from the Fondazione Policlinico Gemelli retrospectively and prospectively to analyse them morphologically and immunopathologically and to correlate them with molecular genetic aspects This study will help to clarify and develop a more effective multidisciplinary diagnostic-therapeutic pathway
Detailed Description:
The purpose of this research is to prospectively and retrospectively collect sebaceous carcinomas from the Fondazione Policlinico Gemelli examine them immunopathologically and morphologically and establish a correlation between these characteristics and molecular genetic factors Conducting this research will contribute to the elucidation and advancement of a multidisciplinary therapeutic-diagnostic pathway The study will utilise surgical specimens irrespective of the disease stage that have been formalin-fixed and paraffin-embedded These specimens were previously collected for clinical practise at the Ocular Oncology of Fondazione Policlinico A Gemelli IRCCS The informed consent of the patients regarding the use of these specimens for research purposes was obtained beforehandEach specimen will be subjected to a comprehensive microscopic examination followed by precise subclassification in accordance with the WHO classification and immunophenotypic characterization An exhaustive collection of conventionally standardised histopathological prognostic attributes for sebaceous carcinomas will be compiled Following this tissue samples are sent for single andor multiple IHC Tumour tissues will be subjected to automated digital quantification in conjunction with multiparametric cell line evaluation Integrating IHC with digital automation of analysisExome sequencing will be performed on DNA extracted from paraffin-embedded sections in order to detect variants that are specific to tumours
For each tumour three to nine sections 10 micrometres in thickness will be utilised as the DNA source Following the identification and separation of tumour tissue from normal tissue by the pathologist the two DNAs will be sequenced independently A comparison will be made between variants derived from tumour and normal tissue with contrasting results Anticipated outcomes include 1 somatic or tumor-specific variants which are non-existent in healthy tissue and 2 variants that are lost during the evolution of the tumour as a result of segmental chromosomal deletion or other mechanisms that induce heterozygosity loss During the projects prospective phase newly developed tumours will be preserved Furthermore this resource will facilitate methylome analysis which is in addition to exome analysis
For each tumour three to nine sections 10 micrometres in thickness will be utilised as the DNA source Following the identification and separation of tumour tissue from normal tissue by the pathologist the two DNAs will be sequenced independently A comparison will be made between variants derived from tumour and normal tissue with contrasting results Anticipated outcomes include 1 somatic or tumor-specific variants which are non-existent in healthy tissue and 2 variants that are lost during the evolution of the tumour as a result of segmental chromosomal deletion or other mechanisms that induce heterozygosity loss During the projects prospective phase newly developed tumours will be preserved Furthermore this resource will facilitate methylome analysis which is in addition to exome analysis
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