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

NCT06620055 | Recruiting

• 1 other identifier: CRO-2023-40
• Study Type: observational
• Target: 164
• Locations: 1 country
• Sites: 3

Brief Summary

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

Glioma

Outcome Measures

Primary Outcomes (1)

• proportion of patients, out of total patients number, with molecular characteristics susceptible to potential drug therapies ('druggable') identified using an AI model

  proportion of patients, out of total patients number, with molecular characteristics susceptible to potential drug therapies ('druggable') identified using an AI model

  24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

164 patients with a histopathological diagnosis of glioma

You may qualify if:

• 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;
• Age \>=18 years;
• Patients must understand and provide written informed consent;
• Life expectancy \>3 months;
• 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;
• Presence of available and accessible clinical and histopathological data.

You may not qualify if:

• Refusal of informed consent;
• Uncooperative patients;
• Presence of other neoplastic diseases in the last 5 years;
• Pregnant and/or breastfeeding women

Sponsors & Collaborators

• Centro di Riferimento Oncologico - Aviano: lead

Study Sites (3)

Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS

Aviano, Pordenone, 33081, Italy

RECRUITING

IOV

Padua, Italy

RECRUITING

Azienda Sanitaria Universitaria Friuli Centrale (ASUFC

Udine, 33100, Italy

RECRUITING

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Giuseppe Toffoli

  Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS

  PRINCIPAL INVESTIGATOR

• Maurizio Polano

  Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS

  STUDY CHAIR

Central Study Contacts

Giuseppe Toffoli

CONTACT

0434 659 612; gtoffoli@cro.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: November 16, 2023
• Primary Completion (Estimated): November 16, 2028
• Study Completion (Estimated): November 16, 2028
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

IT (3)