Department of Oncology, Odense University Hospital, Odense, Denmark.
Department of Pathology, Odense University Hospital, Odense, Denmark.
BMC Med Genomics. 2024 Nov 21;17(1):274. doi: 10.1186/s12920-024-02033-z.
Genomic profiling of advanced solid cancer in patients with no further evidence based standard treatment options is a novel approach to identify potential experimental treatment options based on specific genomic alterations. Due to the expected short survival of these patients timely assessment of potential druggable targets is critical to minimize the risk of deterioration during the analysis. The primary objective of this prospective study is to evaluate the turnaround time for genomic profiling and the clinical investigational procedures. The secondary objectives are to investigate how often genomic alterations in tumor tissue gives rise to a matched treatment offer and evaluate the clinical outcome.
The PRECODE study is a prospective, non-randomized, single-center cohort study conducted at Departments of Oncology and Pathology, Odense University Hospital, Denmark. Enrollment between March 1, 2019 and December 31, 2024. Eligibility criteria are age ≥ 18 years, written informed consent, advanced solid tumors, exhausted treatment options, ECOG performance status 0-2, adequate organ function and life expectancy ≥ 3 months. A core needle biopsy is analyzed by next generation sequencing using a pan-cancer comprehensive panel. Results are discussed weekly at institutional/local and national multidisciplinary tumor boards.
Strategies and methods for genomic profiling of advanced solid cancers differ. Rapid analysis and interpretation of sequencing data are key to avoiding delays in initiation potential experimental treatments, as these late-stage patients may quickly deteriorate. Although a highly optimized setup with fast-track clinical evaluation and genomic profiling has been established a subset will not be offered a targeted treatment due to deterioration. Local and national multidisciplinary teams have been established to optimize individualized treatment decisions. After genomic profiling a subset of patients will take part in clinical trials, which will constrain the reporting of overall survival or progression free survival.
Danish Ethics Committee, Projekt-ID: S-2018014, date of approval: 27- FEB- 2019) Danish Data Protection Agency (Journal no: 18/58329, date of approval: 23-NOV-2018).
gov Identifier: NCT05385081 (retrospectively registered).
对没有进一步基于证据的标准治疗选择的晚期实体瘤患者进行基因组分析是一种新的方法，可以根据特定的基因组改变来确定潜在的实验性治疗选择。由于这些患者的预期生存时间较短，因此及时评估潜在的可用药靶点对于最大限度地降低分析过程中恶化的风险至关重要。本前瞻性研究的主要目的是评估基因组分析和临床研究程序的周转时间。次要目标是调查肿瘤组织中的基因组改变是否经常导致匹配的治疗方案，并评估临床结果。
PRECODE 研究是一项在丹麦奥登塞大学医院肿瘤学和病理学系进行的前瞻性、非随机、单中心队列研究。招募时间为 2019 年 3 月 1 日至 2024 年 12 月 31 日。入选标准为年龄≥18 岁、书面知情同意、晚期实体瘤、治疗选择耗尽、ECOG 表现状态 0-2、器官功能和预期寿命足够且≥3 个月。核心针活检通过下一代测序使用泛癌综合面板进行分析。结果每周在机构/本地和国家多学科肿瘤委员会上进行讨论。
晚期实体癌的基因组分析策略和方法不同。快速分析和解释测序数据是避免潜在实验性治疗启动延迟的关键，因为这些晚期患者可能会迅速恶化。尽管已经建立了具有快速临床评估和基因组分析的高度优化设置，但由于病情恶化，仍有一部分患者将无法获得靶向治疗。已经建立了本地和国家多学科团队，以优化个体化治疗决策。在基因组分析后，一部分患者将参加临床试验，这将限制总生存期或无进展生存期的报告。
丹麦伦理委员会，项目 ID：S-2018014，批准日期：2019 年 2 月 27 日；丹麦数据保护局（期刊编号：18/58329，批准日期：2018 年 11 月 23 日）。
gov 标识符：NCT05385081（回顾性注册）。
