Comprehensive Cancer Centre, King's College London, London, UK.
Head and Neck Pathology, Guy's and St Thomas' Hospitals NHS Trust, London, UK.
BMJ Open. 2024 Oct 10;14(10):e084176. doi: 10.1136/bmjopen-2024-084176.
Organoids have been successfully used in several areas of cancer research and large living biobanks of patient-derived organoids (PDOs) have been developed from various malignancies. The characteristics of the original tumour tissue such as mutation signatures, phenotype and genetic diversity are well preserved in organoids, thus showing promising results for the use of this model in translational research. In this study, we aim to assess whether we can generate PDOs from head and neck squamous cell carcinoma (HNSCC) samples and whether PDOs can be used to predict treatment sensitivity in HNSCC patients as well as to explore potential biomarkers.
This is a prospective observational study at a single centre (Guy's and St Thomas' NHS Foundation Trust) to generate PDOs from patients' samples to assess treatment response and to correlate with patients' treatment outcomes. Patients will be included if they are diagnosed with HNSCC undergoing curative treatment (primary surgery or radiotherapy) or presenting with recurrent or metastatic cancers and they will be categorised into three groups (cohort 1: primary surgery, cohort 2: primary radiotherapy and cohort 3: recurrent/metastatic disease). Research tumour samples will be collected and processed into PDOs and chemosensitivity/radiosensitivity will be assessed using established methods. Moreover, blood and other biological samples (eg, saliva) will be collected at different time intervals during treatment and will be processed in the laboratory for plasma and peripheral blood mononuclear cell (PBMC) isolation. Plasma and saliva will be used for circulating tumour DNA analysis and PBMC will be stored for assessment of the peripheral immune characteristics of the patients as well as to perform co-culture experiments with PDOs. SOTO study (correlation of the treatment Sensitivity of patient-derived Organoids with Treatment Outcomes in patients with head and neck cancer) uses the collaboration of several specialties in head and neck cancer and has the potential to explore multiple areas of research with the aim of offering a valid and effective approach to personalised medicine for cancer patients.
This study was approved by North West-Greater Manchester South Research Ethics Committee (REC Ref: 22/NW/0023) on 21 March 2022. An informed consent will be obtained from all participants prior to inclusion in the study. Results will be disseminated via peer-reviewed publications and presentations at international conferences.
NCT05400239.
类器官已成功应用于癌症研究的多个领域，并且已经从各种恶性肿瘤中开发出了大型的患者来源的类器官（PDO）活体生物库。类器官很好地保留了原始肿瘤组织的特征，如突变特征、表型和遗传多样性，因此在转化研究中使用该模型显示出有前景的结果。在这项研究中，我们旨在评估我们是否可以从头颈部鳞状细胞癌（HNSCC）样本中生成 PDO，以及 PDO 是否可用于预测 HNSCC 患者的治疗敏感性，并探索潜在的生物标志物。
这是一项在单一中心（盖伊和圣托马斯 NHS 基金会信托）进行的前瞻性观察性研究，旨在从患者样本中生成 PDO 以评估治疗反应，并与患者的治疗结果相关联。如果患者被诊断患有接受根治性治疗（原发性手术或放疗）的 HNSCC 或出现复发性或转移性癌症，将纳入患者；他们将被分为三组（队列 1：原发性手术，队列 2：原发性放疗，队列 3：复发性/转移性疾病）。研究性肿瘤样本将被收集并加工成 PDO，并使用已建立的方法评估化疗敏感性/放疗敏感性。此外，将在治疗的不同时间间隔收集血液和其他生物样本（例如唾液），并在实验室中进行处理以分离血浆和外周血单核细胞（PBMC）。将使用血浆和唾液进行循环肿瘤 DNA 分析，将 PBMC 储存起来用于评估患者的外周免疫特征，并与 PDO 进行共培养实验。SOTO 研究（患者来源的类器官的治疗敏感性与头颈部癌症患者的治疗结果的相关性）利用了头颈部癌症多个专业领域的合作，有潜力探索多个研究领域，旨在为癌症患者提供有效的个性化医疗方法。
该研究于 2022 年 3 月 21 日获得了西北-大曼彻斯特南研究伦理委员会（REC 参考：22/NW/0023）的批准。在纳入研究之前，将从所有参与者处获得知情同意。结果将通过同行评议的出版物和国际会议上的演讲进行传播。
NCT05400239。
