Impact of Fluorescence-Guided Resection and Chemoradiotherapy on the Systemic Immune Response in Glioblastoma: A Kinetic Analysis of Immune Biomarkers. (SHAM INDYGO/DO)
28 de abril de 2026 actualizado por: University Hospital, Lille
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Estimado)
17
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Nicolas Pr REYNS, PU-PH
- Número de teléfono: 33 320 44 65 42
- Correo electrónico: nicolas.reyns@chu-lille.fr
Copia de seguridad de contactos de estudio
- Nombre: Nadira Pr DELHEM, PU
Ubicaciones de estudio
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Lille, Francia
- CHU Lille
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Contacto:
- Nicolas REYNS, PU PH
- Número de teléfono: 33 3 20 44 65 42
- Correo electrónico: nicolas.reyns@chu-lille.fr
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
Inclusion Criteria:
- Patient male or female ≥18 years
- General status (WHO) of Performance status 0, 1 or 2
- Probable glioblastoma according to clinical and radiological criteria,
- whose surgical indication was given in Multidisciplinary consultation meeting (RCP) of neurooncology,
- Decision to treat the patient as part of the Clinical trial also taken in neuro-oncology RCP ("Multidisciplinary consultation meeting")
- Patient operable on the basis of absence of cardiopulmonary disease history; a complete medical check-up sufficient to insure a post-operative state with normal daily life
- Clinical neuro-oncological monitoring and long-term MRI scheduled at the hospital CHRU of Lille, center of reference of the region
- Patient able to understand and sign voluntarily Informed consent
- Patient able to adhere to the visit's calendar of the study and other imperatives of the protocol
- Women of child-bearing potential should benefit of an effective contraception
- For patients receiving hepatotoxic therapy in the long term, this treatment must be suspended during the 24h after taking 5-ALA
- Patient assigned to an health insurance
Exclusion Criteria:
Contraindications to 5-ALA (Gliolan®)
- Porphyria
- Taking photosensitizer treatment
- Severe renal or hepatic impairment
- Bilirubin> 1.5 x maximum level, Alkaline Phosphatases and transaminases (ASAT)> 2.5 x Maximum rates
- Creatinine clearance <30 mL / min;
- Non-compliance with the rules of prevention of the transient risk of cutaneous photosensitization
- 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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Evolution of systemic immune response over 6 months following fluorescence-guided resection and during chemoradiotherapy
Periodo de tiempo: From baseline (pre-surgery) to 6 months post-surgery
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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.
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From baseline (pre-surgery) to 6 months post-surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Evolution of immune cells transcriptomic profile
Periodo de tiempo: From baseline (pre-surgery) to 6 months post-surgery
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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.
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From baseline (pre-surgery) to 6 months post-surgery
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Immunomodulatory effects of circulating exosomes following glioblastoma resection and during chemoradiotherapy
Periodo de tiempo: From baseline (pre-surgery) to 6 months post-surgery
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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.
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From baseline (pre-surgery) to 6 months post-surgery
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Nicolas REYNS, PU-PH, CHU Lille
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
15 de junio de 2026
Finalización primaria (Estimado)
15 de diciembre de 2027
Finalización del estudio (Estimado)
15 de junio de 2028
Fechas de registro del estudio
Enviado por primera vez
28 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
28 de abril de 2026
Publicado por primera vez (Actual)
6 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
28 de abril de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2024_0446
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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