Impact of Fluorescence-Guided Resection and Chemoradiotherapy on the Systemic Immune Response in Glioblastoma: A Kinetic Analysis of Immune Biomarkers. (SHAM INDYGO/DO)
2026年4月28日 更新者：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.
調査の概要
研究の種類
観察的
入学 (推定)
17
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Nicolas Pr REYNS, PU-PH
- 電話番号：33 320 44 65 42
- メール：nicolas.reyns@chu-lille.fr
研究連絡先のバックアップ
- 名前：Nadira Pr DELHEM, PU
研究場所
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-
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Lille、フランス
- CHU Lille
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コンタクト：
- Nicolas REYNS, PU PH
- 電話番号：33 3 20 44 65 42
- メール：nicolas.reyns@chu-lille.fr
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Evolution of systemic immune response over 6 months following fluorescence-guided resection and during chemoradiotherapy
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Evolution of immune cells transcriptomic profile
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月15日
一次修了 (推定)
2027年12月15日
研究の完了 (推定)
2028年6月15日
試験登録日
最初に提出
2026年4月28日
QC基準を満たした最初の提出物
2026年4月28日
最初の投稿 (実際)
2026年5月6日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月6日
QC基準を満たした最後の更新が送信されました
2026年4月28日
最終確認日
2026年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。