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Implementation of the Methylome in the Characterization of Solid Tumors

NCT ID: NCT07268066

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-21

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Solid Tumor Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Giovanni Tallini

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCCS Azienda Ospedaliero Univesitaria di Bologna

Bologna, BO, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Giovanni Tallini, Prof.

Role: CONTACT

Phone: +39 338 9763329

Email: [email protected]

Facility Contacts

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Giovanni Tallini, Prof.

Role: primary

Other Identifiers

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RC-2024-2790626

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

RC-2024-2790626

Identifier Type: -

Identifier Source: org_study_id