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Glioma, Malignant clinical trials

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NCT ID: NCT06381726 Recruiting - Glioma Clinical Trials

Personalized Rendering of Motor System Functional Plasticity Potential to Improve Glioma Resection and Quality of Life

Start date: March 7, 2024
Phase: N/A
Study type: Interventional

Background Lower-grade-gliomas affect young patients, thus the longest progression-free-survival (PFS) with a high level quality of life is crucial. Surgery most significantly impacts on tumor natural history, postponing recurrence, improving symptoms, decreasing the need of adjuvant therapies, with extent of resection, gross-total and supra-total (GTR and STR), strongly associating with longest PFS. Achievement of GTR or STR depends on the degree of functional reorganization induced by glioma. Consequently, a successful treatment fostering neural circuit reorganization before surgery, would increase the chance of GRT/STR. Hypothesis The plastic potential of motor system suggests that reorganization of circuits controlling hand movements could be presurgically fostered in LGG patients by enhancing plasticity with up-front motor-rehabilitation and/or by decreasing tumor infiltration with up-front chemotherapy. Advanced neuroimaging allows to infer the neuroplasticity potential. Intraoperative assessment of the motor circuits functionality will validate reliability of preoperative analyses. Aims The project has 4 aims, investigating: A) the presurgical functional (FC) and structural (SC) connectomics of the hand-motor network to picture the spontaneous reorganization and the influence of clinical, imaging and histomolecular variables; B) the dynamic of FC and SC after tumor resection; C) changes in FC and SC maps after personalized upfront motor rehabilitation and/or chemotherapy; D) the effect of FC and SC upfront treatment on the achievement of GTR/STR preserving hand dexterity. Experimental Design Resting-state fMRI and diffusion-MRI will provide FC and SC maps pre- and post-surgery; personalized up-front motor rehabilitation and/or chemotherapy will be administered; Intraoperative brain mapping procedures will generate data to validate the maps. Expected Results 1. Provide a tool to render the motor functional reorganization predictive of surgical outcome. 2. Identify demographic, clinical and imaging variables associated with functional reorganization. 3. Describe the gain induced by up-front treatment. 4. Distinguish "patterns" predicting chance for GTR/STR from "patterns" suggesting need for up-front treatment. Impact On Cancer Results will increase the achievement of GTR/STR, preserving motor integrity, with dramatic impact on LGGs natural history.

NCT ID: NCT06203496 Recruiting - Glioma, Malignant Clinical Trials

Monitoring of Patients With Diffuse Gliomas Using Circulating miRNAs

GliomiR
Start date: January 1, 2024
Phase:
Study type: Observational

MicroRNAs are small non-coding RNAs involved in the post-transcriptional regulation of genes and, consequently, of intracellular signalling pathways that govern cellular behaviour (Komatsu et al., 2023). They are widely implicated in oncogenesis, and in particular in mechanisms promoting cell migration, invasion and proliferation (Romano et al., 2021). Several preliminary studies have shown that serum levels of pro-oncogenic microRNAs correlate with tumor rates in gliomas (Jones et al., 2021; Levallet et al., 2022; Morokoff et al., 2020). Morokoff's study showed encouraging but insufficient results on the possibility of using microRNAs to differentiate radionecrosis versus recurrence. These results need to be consolidated prospectively, with homogeneous samples taken from all patients. The aim of this study is to describe the evolution over time of plasma levels of pro-oncogenic microRNAs, after surgery for grade 4 glioma, in order to assess whether they can be used to identify false-positive recurrences on MRI (radionecrosis).

NCT ID: NCT06196918 Recruiting - Glioma, Malignant Clinical Trials

Efficacy and Safety of Rivaroxaban in the Prevention of Venous Thromboembolism in Glioma Patients

Start date: November 1, 2023
Phase: N/A
Study type: Interventional

Glioma is a common brain tumor with a high risk of venous thromboembolism during treatment, especially in the months after surgery. Postoperative lower extremity dyskinesia in patients with gliomas is considered as a high-risk factor for venous thromboembolism. Rivaroxaban, as an oral anticoagulants, has similar effect in the prevention and treatment of tumor-related venous thromboembolism compared to low molecular weight heparin. Given the lack of prospective supporting data, the efficacy and safety of rivaroxaban in the prevention of postoperative venous thromboembolism in glioma patients with postoperative lower extremity dyskinesia need to be established.

NCT ID: NCT06038760 Recruiting - Glioblastoma Clinical Trials

Prospective Evaluation of AI R&D Tool in Adult Glioma and Other Primary Brain Tumours (PEAR-GLIO)

PEAR-GLIO
Start date: October 12, 2023
Phase:
Study type: Observational

Pear Bio has developed a 3D microtumor assay and computer vision pipeline through which the response of an individual patient's tumor to different anti-cancer regimens can be tested simultaneously ex vivo. This study will recruit patients with primary brain tumors who are due to undergo surgery. Oncologists will be blinded to treatment response on the Pear Bio tool (the assay will be run in parallel with the patient's treatment). The primary objective of this study is to establish the ex vivo model and confirm whether approved therapies exhibit their intended mechanism of action in the model. Secondary objectives include correlating test results to patient outcomes, where available.

NCT ID: NCT05979064 Recruiting - Glioblastoma Clinical Trials

Omental Tissue Autograft in Human Recurrent Glioblastoma Multiforme (rGBM)

Start date: April 4, 2023
Phase: N/A
Study type: Interventional

This single center, single arm, open-label, phase I study will assess the safety of laparoscopically harvested autologous omentum, implanted into the resection cavity of recurrent glioblastoma multiforme (GBM) patients.

NCT ID: NCT05954858 Recruiting - Glioblastoma Clinical Trials

Surgical Tissue Flap to Bypass the Blood Brain Barrier in Glioblastoma

Start date: June 29, 2023
Phase: N/A
Study type: Interventional

This single center, single arm, open-label, phase 2 study will assess the safety and efficacy of a pedicled temporoparietal fascial (TPF) or pericranial flap into the resection cavity of newly diagnosed glioblastoma multifome (GBM) patients. The objective of the Phase 2 study is to demonstrate that this surgical technique is safe and effective in a human cohort of patients with resected newly diagnosed AA or GBM and may improve progression-free survival (PFS) and overall survival (OS).

NCT ID: NCT05773326 Recruiting - Glioblastoma Clinical Trials

Superselective Intra-arterial Cerebral Infusion of Temsirolimus in HGG

Start date: May 15, 2023
Phase: Early Phase 1
Study type: Interventional

This is a single-center, open-label, dose-escalating Phase 0 trial that will enroll participants with a confirmed diagnosed recurrent high-grade glioma (grade 3 or 4 per WHO criteria) targeting the mTOR pathway. Eligible participants will be administered a single infusion of temsirolimus through super-selective intra-arterial infusion or intravenous infusion. Participants will receive the study drug administration on the same day as the planned surgical resection of the tumor.

NCT ID: NCT05772767 Recruiting - Glioblastoma Clinical Trials

Modulation of Ciliogenesis in Glioma Stem Cells

RF2019-1236878
Start date: February 15, 2021
Phase: N/A
Study type: Interventional

The study aims at investigating the cilium-related transcriptome in patients-derived glioblastoma stem cells and the potential impact of modulation of cilium players in vitro, in vivo and ex vivo in glioblastoma brain organoids. Moreover, drugs inhibiting cilia disassembly will be tested. Finally, the potential prognostic role of a cilium-related gene expression signature in glioblastoma will be assessed.

NCT ID: NCT05772741 Recruiting - Glioblastoma Clinical Trials

Grafts of GSCs Into Brain Organoids for Testing Anti-invasion Drugs

2253
Start date: December 3, 2018
Phase: N/A
Study type: Interventional

In patients operated for glioblastoma, glioma stem-like cell lines will be obtained from tumor tissue, and IPSCs from skin fibroblasts or PBMCs. Brain organoids will be generated from IPSCs and co-cultured with IPSCs to study brain invasion and ciliogenesis. 3D genome architecture of glioma stem-like cells will be investigated. Gene modulation and pharmacologic strategies to inhibit invasion and restore ciliogenesis will be explored.

NCT ID: NCT05695976 Recruiting - Glioblastoma Clinical Trials

GRETeL: Tumor Response to Standard Radiotherapy and TMZ Patients With GBM

Start date: April 18, 2023
Phase:
Study type: Observational

The purpose of this study is to better define longitudinal genomic alterations in patients with glioblastoma (GBM), and to determine if plasma circulating tumor DNA (ctDNA) or cell free DNA (cfDNA) is associated with disease recurrence, survival, tumor characteristics, and/or peripheral immunosuppression.