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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06620055
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Centro di Riferimento Oncologico - Aviano
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Giuseppe ToffoliMaurizio Polano
Principal Investigator Affiliation Centro di Riferimento Oncologico di Aviano (CRO) - IRCCSCentro di Riferimento Oncologico di Aviano (CRO) - IRCCS
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Italy
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioma
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Aviano, Pordenone, Italy

Status

Recruiting

Address

Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS

Aviano, Pordenone, 33081

Site Contact

Maurizio Polano

[email protected]

0434 659 612

IOV, Padova, Italy

Status

Recruiting

Address

IOV

Padova, ,

Site Contact

Giuseppe Lombardi, MD

[email protected]

0434 659 612

Udine, Italy

Status

Recruiting

Address

Azienda Sanitaria Universitaria Friuli Centrale (ASUFC

Udine, , 33100

Site Contact

Miran Skrap

[email protected]

0434 659 612

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