Clinical Research Directory

Metabolomics and Transcriptomics of Low- and High-Grade Gliomas

The goal of this observational study is to better define the molecular profile of rare brain tumors (gliomas) based on the levels of their metabolites and transcripts (the intermediate step between DNA information and proteins). The main question it aims to answer is to identify new brain tumour subgroups of clinical relevance that might explain the very different history these patients might follow. Additionally, studies on gliomas require cellular cultures and animal models for the development of new medications, but these models are still scarce and rudimental for many types of gliomas. The second aim of this study is to implement better models for these tumors, for a more effective development of new medications. Patients enrolled in this study will not undergo any additional procedures with respect to those necessary for gold-standard management of these brain tumors. A small sample of the resected tumour will be used for advanced analyses investigating the metabolic and transcriptomic profile and used for temptative establishment of cellular cultures and animal models of these pathologies.

Safety and Feasibility of First-line Avutometinib and Defactinib in Patients With Newly Diagnosed High-grade Gliomas

This clinical trial is designed with two treatment stages: Stage 1: one cycle of study drug treatment prior to initiation of first-line standard radiation in all study participants. Stage 2: two additional cycles of study drug treatment (8 weeks total) concomitantly with standard of care radiation (\~6 weeks) for participants with pathology-confirmed MGMT (enzyme O-6-methylguanine-DNA methyltransferase) unmethylated GBM only. The co-primary endpoints of the study are 1) feasibility of completing Stage 1 of treatment prior to radiation in all study participants and starting radiation within 6 weeks, and 2) safety of study drug across both treatment parts. The investigators will additionally evaluate the radiographic response rate after the first cycle of drug in all patients based upon RANO 2.0 (Response Assessment in Neuro-Oncology) criteria as well as safety of study drug in all patients (secondary endpoints). Exploratory endpoints will include characterization of ERK (extracellular signal-regulated kinase) and FAK (Focal adhesion kinase) dependence in pre-treatment tissue (by immunohistochemistry and/or 'omics) and correlation of expression and co-mutations with response and survival. A total of up to 22 evaluable patients can be enrolled in this study. Evaluable patients are those who have received at least one dose of study drug treatment. Patients who do not start drug will be replaced, up to a total of 28 patients.

GliomaAI-GBM: MRI-Based Detection of IDH Wildtype Glioblastoma

The goal of this observational study is to learn whether an artificial intelligence system called GliomaAI-GBM can help detect a specific molecular type of brain tumour called IDH wildtype glioblastoma using routine MRI scans. The study uses previously collected and fully anonymised MRI data from 1,372 patients from 13 institutions in the Cancer Imaging Archive (TCIA). The main questions it aims to answer are: * How accurately can GliomaAI-GBM identify IDH wildtype glioblastoma from MRI scans? * How well does the system perform across data from different hospitals and patient groups? Researchers will use existing MRI scans and clinical information to train and test the AI system. No new scans, treatments, or hospital visits are required for participants, and all data used is fully anonymised and obtained from an existing research database. Participants will not be asked to do anything, as this study only uses previously collected imaging data.