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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 uppdaterad 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Beräknad)

17

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

  • Namn: Nadira Pr DELHEM, PU

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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).
Procedur: Fluorescence-guided resection (FGR)
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Evolution of systemic immune response over 6 months following fluorescence-guided resection and during chemoradiotherapy
Tidsram: From baseline (pre-surgery) to 6 months post-surgery
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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Evolution of immune cells transcriptomic profile
Tidsram: From baseline (pre-surgery) to 6 months post-surgery
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
Immunomodulatory effects of circulating exosomes following glioblastoma resection and during chemoradiotherapy
Tidsram: From baseline (pre-surgery) to 6 months post-surgery
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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University Hospital, Lille

Samarbetspartners

Lille University

Utredare

  • Huvudutredare: Nicolas REYNS, PU-PH, CHU Lille

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

15 juni 2026

Primärt slutförande (Beräknad)

15 december 2027

Avslutad studie (Beräknad)

15 juni 2028

Studieregistreringsdatum

Först inskickad

28 april 2026

Först inskickad som uppfyllde QC-kriterierna

28 april 2026

Första postat (Faktisk)

6 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 april 2026

Senast verifierad

1 april 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2024_0446

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

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Nej

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