Boos Laura Amanda, Doerig Christian, Gut Gabriele, Miglino Nicola, Fábregas Ibáñez Luis, Rizzo Shemra, Schärfe Fruechtenicht Charlotta, Chitale Nandini, Lu Charles, Zoche Martin, Bodenmiller Bernd, Chevrier Stephane, Eklund Alexandra Sophia, Nowak Marta, Rahmani Khajouei Sepehr, Berardo Carmen Galani, Kaczmarek Lukasz, Bosshard Karin, Archey William, Bodmer Matthias, Glinz Dominik, Camarillo-Retamosa Eva, Hempel Chiara Louisa, Rahimzadeh Parisa, Gosztonyi Benedict, Richter Ulrich, Bankel Lorenz, Wicki Andreas
Department of Medical Oncology and Hematology, University Hospital Zurich, Zurich, Switzerland.
F. Hoffmann-La Roche AG, Basel, Switzerland.
BMJ Open. 2025 Mar 26;15(3):e096591. doi: 10.1136/bmjopen-2024-096591.
Precision oncology aims to provide individualised treatment recommendations based on patient-specific characteristics. In this rapidly evolving field with increasing numbers of biomarkers and potential therapeutic targets, there is a growing unmet need for evidence guiding these individualised treatment recommendations. The Precision Oncology Program (POP) harnesses real-world data (RWD) and imaging mass cytometry (IMC) to evaluate the feasibility and utility of integrating different data modalities to inform personalised treatment recommendations. This program uses patient-matched clinicogenomic data and spatial single-cell proteomics analysis to support profiling-driven decision-making for patients with cancer at the Molecular Tumor Board.
The collaborative POP project recruits patients across all tumour entities and stages at the Comprehensive Cancer Center Zurich (CCCZ). For patients in the POP, a clinically and molecularly matched cohort is identified within the nationwide (US-based) de-identified Flatiron Health-Foundation Medicine clinicogenomic database (CGDB). It assesses whether clinical, genomic and outcome data of the CGDB cohort can inform treatment recommendations. In addition, multiplexed imaging mass cytometry (IMC) is performed in formalin-fixed paraffin-embedded tissue to assess the potential impact of spatial proteomics on personalised treatment decisions. RWD and IMC information is reviewed in the Molecular Tumor Board to assess the potential impact of this information on therapy decisions. However, since this is an observational study, these additional recommendations remain nonprescriptive and will not be forwarded to the treating physician.
The study is registered at ClinicalTrials.gov (NCT06680726) and approved by the Canton of Zurich Ethics Committee (Project ID: 2022-02289). Project-specific informed consent is obtained from all participants. Deceased patients may also be included. In this case, a signed general consent form must be available. Data privacy is ensured by unique patient numbers for pseudo-anonymised data. Study findings will be disseminated through international peer-reviewed journals, conferences, and direct communication with participants and relevant organisations.
NCT06680726.
精准肿瘤学旨在根据患者的特定特征提供个性化的治疗建议。在这个生物标志物和潜在治疗靶点数量不断增加的快速发展领域，对于指导这些个性化治疗建议的证据的需求日益迫切且未得到满足。精准肿瘤学项目（POP）利用真实世界数据（RWD）和成像质谱流式细胞术（IMC）来评估整合不同数据模式以提供个性化治疗建议的可行性和实用性。该项目使用患者匹配的临床基因组数据和空间单细胞蛋白质组学分析，以支持分子肿瘤委员会对癌症患者进行基于分析的决策。
合作的POP项目在苏黎世综合癌症中心（CCCZ）招募所有肿瘤类型和分期的患者。对于POP项目中的患者，在全国范围（美国）的去识别化Flatiron Health - Foundation Medicine临床基因组数据库（CGDB）中确定一个临床和分子匹配的队列。它评估CGDB队列的临床、基因组和结局数据是否能为治疗建议提供信息。此外，在福尔马林固定石蜡包埋组织中进行多重成像质谱流式细胞术（IMC），以评估空间蛋白质组学对个性化治疗决策的潜在影响。在分子肿瘤委员会中审查RWD和IMC信息，以评估这些信息对治疗决策的潜在影响。然而，由于这是一项观察性研究，这些额外的建议仍不具规范性，不会传达给治疗医生。
该研究已在ClinicalTrials.gov注册（NCT06680726），并获得苏黎世州伦理委员会批准（项目编号：2022 - 02289）。从所有参与者处获得特定项目的知情同意书。已故患者也可能被纳入。在此情况下，必须有签署的一般同意书。通过为伪匿名数据分配唯一患者编号来确保数据隐私。研究结果将通过国际同行评审期刊、会议以及与参与者和相关组织的直接沟通进行传播。
NCT06680726。
