Evaluation of PD-L1 Expression and Immune Infiltration in High-risk Non Muscle Invasive Bladder Cancer (IMMUN VESSIE)
Non-muscle-invasive bladder cancer (NMIBC) has a high rate of recurrence (60 to 70%) and progression (20 to 30%) to muscle-invasive bladder cancer (MIBC).
The local immunotherapy (intra-vesical Bacillus Calmette-Guerin (BCG) following transurethral resection of the bladder tumor (TURBT)) reduces significantly the risk of recurrence and progression as compared to observation or to intra-vesical chemotherapy.
Systemic immunotherapy with programmed death ligand-1 (PD-L1) or Programmed cell Death 1 (PD1) inhibitors has shown major efficacy in the treatment of patients with advanced/metastatic urothelial carcinoma who have progressed on platinum-based regimens of chemotherapy, or even in front line setting. In the field of NMIBC, immunotherapy using PD-L1 or PD1 inhibitors is under investigation but the frequency of PD-L1 expression has rarely been precisely described in the different subtypes.
The aim of this retrospective study is to investigate the expression of PD-L1 by different types of NMIBC.
The secondary objective is to characterize the immune contexture of NMIBC.
調査の概要
詳細な説明
Non-muscle-invasive bladder cancer (NMIBC) has a high rate of recurrence (60 to 70%) and progression (20 to 30%) to muscle-invasive bladder cancer (MIBC).
The local immunotherapy (intra-vesical Bacillus Calmette-Guerin (BCG) following transurethral resection of the bladder tumor (TURBT)) reduces significantly the risk of recurrence and progression as compared to observation or to intra-vesical chemotherapy.
Systemic immunotherapy with programmed death ligand-1 (PD-L1) or Programmed cell Death 1 (PD1) inhibitors has shown major efficacy in the treatment of patients with advanced/metastatic urothelial carcinoma who have progressed on platinum-based regimens of chemotherapy, or even in front line setting. In the field of NMIBC, immunotherapy using PD-L1 or PD1 inhibitors is under investigation but the frequency of PD-L1 expression has rarely been precisely described in the different subtypes.
The aim of this retrospective study is to investigate the expression of PD-L1 by different types of NMIBC.
The secondary objective is to characterize the immune contexture of NMIBC. The immunological contexture of NMIBC in comparison with normal bladder tissue and invasive bladder cancer will be deciphered. The objective is to determine immune signatures associated with response or relapse/progression, with and without immune treatments in NMIBC.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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-
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Talence、フランス
- Centre Hospitalier Universitaire de Bordeaux
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
Patients with histologically documented normal bladder, NMIBC (Ta, T1, CIS) or MIBC stored in the tissue bank.
Samples collected from 2007 to 2011. 3 years follow-up is mandatory to assess the frequency of recurrences and progressions.
Exclusion Criteria:
- History of autoimmune disease
- Active tuberculosis
- Prior treatment with CD137 agonists, anti-programmed death-1 (PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents
研究計画
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 |
|---|---|
|
Patients with histologically documented normal bladder
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Samples of bladder tissue collected between 2007 and 2011.
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Patients with histologically documented Non Muscle Invasive Bladder Cancer
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Samples of bladder tissue collected between 2007 and 2011.
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Patients with histologically documented Muscle Invasive Bladder Cancer
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Samples of bladder tissue collected between 2007 and 2011.
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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 |
|---|---|---|
|
PD-L1 status (positive or negative) of the tumor and tumor associated immune cells.
時間枠：Day 1
|
PD-L1 status will be considered positive if more than 25% of tumor cells exhibit membrane staining or immune cells present (ICP) >1% and immune cells (IC)+ >25% or ICP=1% and IC+ = 100%. PD-L1 status will be considered negative if none of the criteria for PD-L1 positive status are met. |
Day 1
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Descriptive analysis of the differential expression of all the following immune biomarkers in normal bladder tissue, NMIBC (Non Muscle Invasive Bladder Cancer) and MIBC (Muscle Invasive Bladder Cancer).
時間枠：Day 1
|
Descriptive statistics will be performed from clinical characteristics as mean values for categorical variables, or medians (range) for non-normal continuous variables.
|
Day 1
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Association of immune profile with recurrence and progression rates
時間枠：Day 1
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Association between all variables will be analysed with t-test, Mann Whitney or ANOVA multiple comparison test.
Correlation analysis will be performed with χ2 and Fischer exact test.
Results will be considered significant if the p-value is <0.05.
|
Day 1
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- CHUBX2018/55
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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