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NCT Number: NCT07268066

Implementation of the Methylome in the Characterization of Solid Tumors

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero Univesitaria di Bologna

Bologna, BO, 40138, Italy

Location status: Recruiting

Location contact

Giovanni Tallini, Prof.

CONTACT

[email protected]

+39 3389763329

About this study

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.

  • 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).
  • Methylation profile:
  • Methylation analysis using ChIP array (Next 550 - Illumina) to generate methylation data.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Identify methylation profiles

    Time frame: from January 2024 to December 2026

    The primary objective of this project is to perform a comprehensive analysis of methylation in glial tumors, endometrial carcinomas, and endocrine neoplasms, with the overall goal of improving their classification and translating the data obtained into clinical practice. Specifically, this project aims to:

    • Characterize DNA methylation patterns in the solid tumors under investigation: this research aims to clarify the specific DNA methylation profiles associated with different types of solid tumors, allowing the identification of unique epigenetic signatures that may contribute to tumor classification;
    • Develop robust predictive models for the classification of the tumors studied;
    • Validate classification models using clinical data;
    • Assess the relevance of methylation-based tumor classification to determine the clinical utility of classification models;
    • Developing an easy-to-use clinical implementation framework.

Study contacts

Contact information is provided by the study sponsor or research team.

Giovanni Tallini, Prof.

CONTACT

[email protected]

+39 338 9763329

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Acronym: AMethiST

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 5, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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