Impact of Fluorescence-Guided Resection and Chemoradiotherapy on the Systemic Immune Response in Glioblastoma: A Kinetic Analysis of Immune Biomarkers. (SHAM INDYGO/DO)
28. april 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Antatt)
17
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Nicolas Pr REYNS, PU-PH
- Telefonnummer: 33 320 44 65 42
- E-post: nicolas.reyns@chu-lille.fr
Studer Kontakt Backup
- Navn: Nadira Pr DELHEM, PU
Studiesteder
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Lille, Frankrike
- CHU Lille
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Ta kontakt med:
- Nicolas REYNS, PU PH
- Telefonnummer: 33 3 20 44 65 42
- E-post: nicolas.reyns@chu-lille.fr
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Evolution of systemic immune response over 6 months following fluorescence-guided resection and during chemoradiotherapy
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Evolution of immune cells transcriptomic profile
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Nicolas REYNS, PU-PH, CHU Lille
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
15. juni 2026
Primær fullføring (Antatt)
15. desember 2027
Studiet fullført (Antatt)
15. juni 2028
Datoer for studieregistrering
Først innsendt
28. april 2026
Først innsendt som oppfylte QC-kriteriene
28. april 2026
Først lagt ut (Faktiske)
6. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. april 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2024_0446
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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