Development of an Artificial Intelligence Model for Optimising Therapy in Gliomas Gliomas

NCT ID: NCT06620055

Last Updated: 2024-10-01

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

164 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-16

Study Completion Date

2028-11-16

Brief Summary

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Artificial intelligence (AI) undoubtedly represents the main tool currently available in the definition of complex algorithms and its use in the medical field is becoming increasingly strategic.As reported in the literature, it is increasingly difficult to find new therapeutic strategies for neoplasms, especially neurological ones. Molecular characterisation is therefore increasingly essential, as is the use of new predictive methods.

With this in mind, the aim of this study is to assess, by means of AI algorithms applied to genomic data, in what percentage molecular alterations are susceptible to potential drug therapies, compared to the literature data that does not consider AI algorithms for this purpose.

Detailed Description

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Artificial intelligence (AI) undoubtedly represents the main tool currently available in the definition of complex algorithms and its use in the medical field is becoming increasingly strategic.As reported in the literature, it is increasingly difficult to find new therapeutic strategies for neoplasms, especially neurological ones. Molecular characterisation is therefore increasingly essential, as is the use of new predictive methods.

With this in mind, the aim of this study is to assess, by means of AI algorithms applied to genomic data, in what percentage molecular alterations are susceptible to potential drug therapies, compared to the literature data that does not consider AI algorithms for this purpose.

Conditions

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Glioma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Patients with a histopathological diagnosis of glioma for whom it is possible to have cryopreserved or fixed in formalin and embedded in paraffin biological material. Specimens may result from incisional biopsy and/or surgical resection and/or blood. Whole blood is taken for germinal analysis;
2. Age \>=18 years;
3. Patients must understand and provide written informed consent;
4. Life expectancy \>3 months;
5. Presence of biological material from resection and blood considered sufficient by quality and quantity to proceed to molecular characterisation in the opinion of the Investigator Principal Investigator;
6. Presence of available and accessible clinical and histopathological data.

Exclusion Criteria

1. Refusal of informed consent;
2. Uncooperative patients;
3. Presence of other neoplastic diseases in the last 5 years;
4. Pregnant and/or breastfeeding women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro di Riferimento Oncologico - Aviano

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giuseppe Toffoli

Role: PRINCIPAL_INVESTIGATOR

Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS

Maurizio Polano

Role: STUDY_CHAIR

Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS

Locations

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Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS

Aviano, Pordenone, Italy

Site Status RECRUITING

IOV

Padua, , Italy

Site Status RECRUITING

Azienda Sanitaria Universitaria Friuli Centrale (ASUFC

Udine, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Giuseppe Toffoli

Role: CONTACT

0434 659 612

Facility Contacts

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Maurizio Polano

Role: primary

Giuseppe Lombardi, MD

Role: primary

Miran Skrap

Role: primary

Marco Vindigni

Role: backup

Other Identifiers

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CRO-2023-40

Identifier Type: -

Identifier Source: org_study_id

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