Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
Study NCT ID:
NCT07268066
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-11-25
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Implementation of the Methylome in the Characterization of Solid Tumors
Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Organization:
Study Overview
Official Title:
Implementation of the Methylome in the Characterization of Solid Tumors
Status:
RECRUITING
Status Verified Date:
2025-11
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:
AMethiST
Brief Summary:
This study aims to investigate the functional consequences of specific methylation changes and to examine the clinical implications of these alterations. Methylation analysis is a powerful tool for understanding the molecular mechanisms of brain tumors and other solid tumors and can help identify new diagnostic and therapeutic targets. By analyzing DNA methylation patterns in tumor tissue, it is possible to identify genes that are silenced or activated by methylation. This information can be used to develop new biomarkers for early diagnosis and to identify new therapeutic targets that can be used to reverse methylation-mediated gene silencing.
Detailed Description:
A total of 180 cases will be collected: 60 central nervous system tumors, 60 endometrial carcinomas, and 60 endocrine tumors (pituitary tumors, adrenal tumors, thyroid tumors).
By following these practical steps, the project aims to develop and implement a methylation-based tumor classification system that improves clinical decision-making and patient care in the field of solid tumor oncology.
1\. Study design and sample collection:
* Select a diverse cohort of patients with various types of solid tumors.
* Collect tumor tissue samples for DNA extraction.
* Select the neoplastic area and extract DNA. 2. NGS profiling:
* Analyze molecular alterations using lab-developed NGS panels developed and in use at the IRCCS molecular pathology laboratory (sequencer: S5 Prime - Thermo Fisher Scientific).
3\. Methylation profile:
* Methylation analysis using ChIP array (Next 550 - Illumina) to generate methylation data.
4\. Clinical correlation and interpretation of data:
* Analyze the clinical relevance of tumor classification based on methylation profile. Define how these classifications relate to clinical parameters, to treatment outcome and survival 5. Development of diagnostic/therapeutic protocols:
* Development of interdisciplinary protocols to implement methylation profile -based tumor classification in the clinical setting.
By following these practical steps, the project aims to develop and implement a methylation-based tumor classification system that improves clinical decision-making and patient care in the field of solid tumor oncology.
1\. Study design and sample collection:
* Select a diverse cohort of patients with various types of solid tumors.
* Collect tumor tissue samples for DNA extraction.
* Select the neoplastic area and extract DNA. 2. NGS profiling:
* Analyze molecular alterations using lab-developed NGS panels developed and in use at the IRCCS molecular pathology laboratory (sequencer: S5 Prime - Thermo Fisher Scientific).
3\. Methylation profile:
* Methylation analysis using ChIP array (Next 550 - Illumina) to generate methylation data.
4\. Clinical correlation and interpretation of data:
* Analyze the clinical relevance of tumor classification based on methylation profile. Define how these classifications relate to clinical parameters, to treatment outcome and survival 5. Development of diagnostic/therapeutic protocols:
* Development of interdisciplinary protocols to implement methylation profile -based tumor classification in the clinical setting.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| RC-2024-2790626 | OTHER_GRANT | Ministero della Salute tramite IRCCS Azienda Ospedaliero Universitaria di Bologna | View |