STRatifying Adult DIffuse Lower-grade Gliomas Based on Their VARIed Metabolic Profiles (STRADIVARI Project)

NCT ID: NCT06794736

Last Updated: 2025-01-27

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

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-14

Study Completion Date

2026-08-31

Brief Summary

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The goal of this observational study is to better characterise lower-grade gliomas from a molecular and metabolic point of view, so to identify further subgroups of these tumours with different behaviour and, possibly, different treatment susceptibility.

Participants of prospective metabolic cohort will be subjected to routine treatment, part of the exceeding tutor material will be subjected to advanced molecular-metabolic analyses to desume their metabolic profile to be then correlated with clinical outcome (progression-free survival, overall survival, response to therapy/progression) and diagnosis (astrocytoma/oligodendroglioma and grade).

Critical enzymes identified from metabolic analyses on the first cohort will be tested on a protein level on a retrospective cohort of patients previously operated and for whom fully available clinical history and pathological material is available in Institutional archive (no need for further intervention on these patients) to see if they actually correlate with clinical outcome.

Detailed Description

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Conditions

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Lower Grade Glioma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Prospective Metabolic Cohort

Patients operated on for lower grade gliomas from whom part of the exceeding pathologic material will be collected for metabolomic profiling

No interventions assigned to this group

Retrospective FFPE Sample Cohort

Historical patient cohort for whom FFPE sections, full clinical history and pathological data are available.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Radiological diagnosis of brain tumor compatible with lower grade glioma
* Full clinical history


* Confirmed diagnosis of lower grade glioma
* Full clinical and radiological history

Exclusion Criteria

* Current pregnancy or lactation
* Patients not able to provide informed consent

Retrospective Cohort of FFPE samples:
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università Vita-Salute San Raffaele

OTHER

Sponsor Role collaborator

University of Bari

OTHER

Sponsor Role collaborator

Ospedale San Paolo Bari

UNKNOWN

Sponsor Role collaborator

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ospedale San Paolo Bari

Bari, Apulia, Italy

Site Status NOT_YET_RECRUITING

Policlinico Bari University Hospital (Bari, Italy)

Bari, Apulia, Italy

Site Status NOT_YET_RECRUITING

Università Vita-Salute San Raffaele

Milan, Lombardy, Italy

Site Status ACTIVE_NOT_RECRUITING

IRCCS Galeazzi-Sant'Ambrogio

Milan, Lombardy, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Lorenzo Bello, MD

Role: CONTACT

+390283502228

Direzione Scientifica IRCCS Galeazzi-Sant'Ambrogio, Milano

Role: CONTACT

+390283502228

Facility Contacts

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Valeria Internò, MD

Role: primary

+390805843721

Francesco Signorelli, MD

Role: primary

+39805597054

Direzione Scientifica

Role: primary

+390283502228

Other Identifiers

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STRADIVARI

Identifier Type: -

Identifier Source: org_study_id

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