Implementation of the Methylome in the Characterization of Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Solid Tumor Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Identify methylation profiles [Time frame: from January 2024 to December 2026]
Eligibility criteria
Inclusion criteria
- Confirmed diagnosis of one of the following types of cancer: gliomas, malignant thyroid neoplasms, or endometrial carcinomas (according to the WHO Nomenclature)
- Availability of adequate material for analysis at the laboratory, specifically availability of at least 3 sections of 10 µm of FFPE
Exclusion criteria
- no
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero Univesitaria di Bologna — Bologna
Identifiers
NCT: NCT07268066 · RC-2024-2790626 · RC-2024-2790626