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

Study Purpose

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.

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 [Patient Registry]
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Prospective Metabolic Cohort:

Inclusion Criteria:

  • - Radiological diagnosis of brain tumor compatible with lower grade glioma.
  • - Full clinical history.

Exclusion Criteria:

  • - Current pregnancy or lactation.
  • - Patients not able to provide informed consent.
Retrospective Cohort of FFPE samples:

Inclusion Criteria:

  • - Confirmed diagnosis of lower grade glioma.
- Full clinical and radiological history

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.

NCT06794736
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.

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

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

N/A
Principal Investigator Affiliation N/A
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.

Lower Grade Glioma
Arms & Interventions

Arms

: Prospective Metabolic Cohort

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

: Retrospective FFPE Sample Cohort

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

Interventions

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

Università Vita-Salute San Raffaele, Milano, Lombardy, Italy

Status

Active, not recruiting

Address

Università Vita-Salute San Raffaele

Milano, Lombardy, 20132

IRCCS Galeazzi-Sant'Ambrogio, Milano, Lombardy, Italy

Status

Recruiting

Address

IRCCS Galeazzi-Sant'Ambrogio

Milano, Lombardy, 20157

Site Contact

Direzione Scientifica

[email protected]

+390283502228

Ospedale San Paolo Bari, Bari, Puglia, Italy

Status

Not yet recruiting

Address

Ospedale San Paolo Bari

Bari, Puglia, 70123

Site Contact

Valeria Internò, MD

[email protected]

+390805843721

Bari, Puglia, Italy

Status

Not yet recruiting

Address

Policlinico Bari University Hospital (Bari, Italy)

Bari, Puglia, 70124

Site Contact

Francesco Signorelli, MD

[email protected]

+39805597054

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