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Impact of Fluorescence-Guided Resection and Chemoradiotherapy on the Systemic Immune Response in Glioblastoma: A Kinetic Analysis of Immune Biomarkers.

Study acronym: SHAM INDYGO/DO
StatusNot Yet Recruiting
PhaseNot specified
Started
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Trial flagged as At Risk
Primary completion moved at least 4 months later Dec 15, 2027 → Apr 15, 2028
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Record History

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  1. Start date: Jun 15, 2026 to Oct 15, 2026 Show 4 more changesShow less
    • Primary completion pushed from Dec 15, 2027 to Apr 15, 2028
    • Study completion pushed from Jun 15, 2028 to Oct 15, 2028
    • Eligibility criteria expanded, about 27 words
    • Secondary endpoints: details revised at 2 of 2 entries
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
University Hospital, Lille
343 trials monitored
See 5 trials at risk
Glioma
1,251 trials monitored
See 88 trials at risk
Glioblastoma
710 trials monitored
See 52 trials at risk
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.
Trial Details
NCT Number NCT07568782
Lead Sponsor University Hospital, Lille
Collaborators: Lille University
Conditions
(from sponsor)		 Glioblastoma
Related terms Glioblastoma
Enrollment 17 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov