Development of an Artificial Intelligence Model for Optim... | NCT06620055

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

NCT06620055

Sponsor

Centro di Riferimento Oncologico - Aviano

Status

Recruiting

Last Update Posted

Oct 1, 2024Actual

Enrollment

164Estimated

Phase

Not provided

Conditions

Glioma

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 16, 2023Actual

Primary Completion Date

Nov 16, 2028Estimated

Completion Date

Nov 16, 2028Estimated

First Submitted Date

Sep 26, 2024

First Submission Date that Met QC Criteria

Sep 26, 2024

First Posted Date

Oct 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2024

Last Update Posted Date

Oct 1, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

164Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

164 patients with a histopathological diagnosis of glioma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Giuseppe Toffoli	Contact	0434 659 612		gtoffoli@cro.it

Overall Officials

Name	Affiliation	Role
Giuseppe Toffoli	Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS	Principal Investigator
Maurizio Polano	Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS	Recruiting	Aviano	Pordenone	33081	Italy

Condition Browse Module

MeSH Terms

ID	Term
D005910	Glioma

Ancestor Terms

ID	Term
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

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