Solid Tumor CancerAMethiSTNCT07268066
Implementation of the Methylome in the Characterization of Solid Tumors
An observational study of Solid Tumor Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Cancer
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- 21 May 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include patients aged 18 years or older who have been diagnosed with adult gliomas, malignant thyroid neoplasms, or endometrial carcinomas. The patient selection period will run from January 2021 to December 2023. The operational unit responsible for patient selection will be the Intercompany Laboratory of Molecular Pathology of Solid Tumors - IRCCS - University Hospital of Bologna - Policlinico S. Orsola. The study will be retrospective and will be based on material already collected from normal clinical practice.
Who may be able to join
- 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
Who cannot join
- no
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero Univesitaria di Bologna
Bologna, BO, 40138
Giovanni Tallini, Prof., +39 3389763329, giovanni.tallini@ausl.bologna.it
About this study
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.
Read the 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.
- 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.
- Conditions
- Solid Tumor Cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify methylation profiles
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.
Measured: from January 2024 to December 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start21 May 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor CancerStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Tallini, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268066
- Sponsor's protocol ID
- RC-2024-2790626
- Other IDs
- RC-2024-2790626
- Acronym
- AMethiST
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of the Methylome in the Characterization of Solid Tumors
- ClinicalTrials.gov ID
- NCT07268066
- Acronym / sponsor ID
- AMethiST / RC-2024-2790626
- Conditions
- Solid Tumor Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 21 May 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include patients aged 18 years or older who have been diagnosed with adult gliomas, malignant thyroid neoplasms, or endometrial carcinomas. The patient selection period will run from January 2021 to December 2023. The operational unit responsible for patient selection will be the Intercompany Laboratory of Molecular Pathology of Solid Tumors - IRCCS - University Hospital of Bologna - Policlinico S. Orsola. The study will be retrospective and will be based on material already collected from normal clinical practice.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- no
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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: 1. 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; 2. Develop robust predictive models for the classification of the tumors studied; 3. Validate classification models using clinical data; 4. Assess the relevance of methylation-based tumor classification to determine the clinical utility of classification models; 5. Developing an easy-to-use clinical implementation framework.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Tallini, Prof. (+39 338 9763329, giovanni.tallini@ausl.bologna.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify methylation profiles (time frame: from January 2024 to December 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.