There has been little change to the standard treatment for osteosarcoma (OS) over the last 25 years and there is an unmet need to identify new biomarkers and novel therapeutic approaches if outcomes are to improve. Furthermore, there is limited evidence on the impact of OS treatment on patient-reported outcomes (PROs). ICONIC (Improving Outcomes through Collaboration in Osteosarcoma; NCT04132895) is a prospective observational cohort study recruiting newly diagnosed OS patients across the United Kingdom (UK) with matched longitudinal collection of clinical, biological, and PRO data. During Stage 1, which assessed the feasibility of recruitment and data collection, 102 patients were recruited at 22 sites with representation from patient groups frequently excluded in OS studies, including patients over 50 years and those with less common primary sites. The feasibility of collecting clinical and biological samples, in addition to PRO data, has been established and there is ongoing analysis of these data as part of Stage 2. ICONIC will provide a unique, prospective cohort of newly diagnosed OS patients representative of the UK patient population, with fully annotated clinical outcomes linked to molecularly characterised biospecimens, allowing for comprehensive analyses to better understand biology and develop new biomarkers and novel therapeutic approaches.
过去25年间，骨肉瘤的标准治疗方案几无变化。若要改善治疗结局，亟需发现新的生物标志物和新型治疗方法。此外，关于骨肉瘤治疗对患者报告结局影响的证据也十分有限。ICONIC研究（通过骨肉瘤协作改善治疗结局；临床试验编号NCT04132895）是一项前瞻性观察队列研究，在英国范围内招募新诊断的骨肉瘤患者，并同步收集临床、生物学及患者报告结局数据。在第一阶段（评估招募与数据收集可行性）中，22个研究中心共招募102例患者，涵盖了骨肉瘤研究中常被排除的患者群体，包括50岁以上患者及原发部位罕见患者。研究已证实临床样本、生物学样本及患者报告结局数据收集的可行性，目前正对这些数据进行第二阶段分析。ICONIC研究将建立具有英国患者群体代表性的新诊断骨肉瘤患者前瞻性队列，该队列具有完整的临床结局注释及分子特征明确的生物样本，为开展全面分析以深入理解疾病生物学特性、开发新型生物标志物和创新治疗方案提供了独特资源。
肿瘤(癌症)患者之家