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| Name | Class |
|---|---|
| Lille University | OTHER |
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The immune system plays a critical role in cancer progression and antitumor responses. Glioblastoma is an aggressive and incurable brain tumor characterized by a highly immunosuppressive microenvironment. Over the past two decades, photodynamic therapy (PDT) has been evaluated as an adjunct to fluorescent-guided resection (FGR) and chemoradiotherapy according to the STUPP protocol, for resectable glioblastomas. In addition to demonstrating the feasibility of such a procedure, two previous clinical trials (INDYGO, NCT03048240; DOSINDYGO, NCT04391062) revealed/highlighted significant systemic immune changes following treatment, including modifications in peripheral blood mononuclear cells (PBMCs) activation and cytokine secretion profiles. However, the specific contribution of PDT remains uncertain due to the combined effects of, on the one hand, PDT and, on the other hand, FGR and chemoradiotherapy. This study aims to evaluate immune parameters in a control population undergoing FGR and chemoradiotherapy only (i.e., without PDT). The objective is to distinguish the immunological impact of PDT from that of FGR and chemoradiotherapy. The results will provide a better understanding of the systemic immune modulation induced by PDT in glioblastoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control No PDT | 17 patients with resectable glioblastoma undergoing FGR and chemoradiotherapy only (i.e., without PDT). These patients are matched 1:1 by age and sex with patients from the completed INDYGO (NCT03048240) and DOSINDYGO (NCT04391062) trials who underwent immunological analysis (6 INDYGO patients and 11 DOSINDYGO patients). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluorescence-guided resection (FGR) | Procedure | Patients undergo fluorescence-guided resection for glioblastoma. Post-operative management includes standard radiochemotherapy according to the STUPP protocol. Peripheral blood samples are collected longitudinally for immunological analyses (PBMCs, immune activation markers, cytokine profiling). This group serves as a matched control cohort for patients in the INDYGO and DOSINDYGO trials who received PDT in addition to FGR and chemoradiotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of systemic immune response over 6 months following fluorescence-guided resection and during chemoradiotherapy | Systemic immune response will be assessed by longitudinal changes in the proportion of circulating immune cell subsets quantified by flow cytometry and by cytokine concentrations measured through secretome analysis. All measurements will be analyzed as variations relative to a pre-operative baseline to evaluate immune modulation following resection and during chemoradiotherapy. | From baseline (pre-surgery) to 6 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of immune cells transcriptomic profile | Changes in exosome-induced immune cell proliferation are assessed in peripheral blood samples. The immunomodulatory effects of circulating exosomes are evaluated through their capacity to induce proliferation of immune cells over time following surgical resection and during chemoradiotherapy. | From baseline (pre-surgery) to 6 months post-surgery |
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Inclusion Criteria:
Exclusion Criteria:
Contraindications to 5-ALA (Gliolan®)
Contraindications to surgery
Contraindications to magnetic resonance imaging (MRI)
Treatment with an experimental drug within 30 Days prior to the start of the study
Clinical follow-up impossible to perform for psychological, familial, social or geographical reasons,
Legal incapacity (persons deprived of their liberty or Guardianship or guardianship),
Pregnant or nursing women
Refusal to participate or sign the consent of the study
Soy allergy
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Adult patients with newly diagnosed resectable glioblastoma undergoing fluorescence-guided resection and chemoradiotherapy according to the STUPP protocol. The study includes a prospective control cohort treated with fluorescence-guided resection and chemoradiotherapy only (i.e., without photodynamic therapy (PDT)) and a historical prospective cohort previously treated with intraoperative PDT (INDYGO and DOSINDYGO trials) combined with fluorescence-guided resection and chemoradiotherapy. All patients receive standard post-operative Stupp protocol. Peripheral blood samples are analyzed for systemic immune profiling.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas Pr REYNS, PU-PH | Contact | 33 320 44 65 42 | nicolas.reyns@chu-lille.fr | |
| Nadira Pr DELHEM, PU | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Nicolas REYNS, PU-PH | CHU Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Lille | Lille | France |
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Whole blood, Peripheral Blood Mononuclear Cells, Serum
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| Immunomodulatory effects of circulating exosomes following glioblastoma resection and during chemoradiotherapy | Changes in exosome-induced immune cell proliferation are assessed in peripheral blood samples. The immunomodulatory effects of circulating exosomes are evaluated through their capacity to induce proliferation of immune cells over time following surgical resection and during chemoradiotherapy. | From baseline (pre-surgery) to 6 months post-surgery |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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