使用实用技术支持平台的前瞻性临床基因组数据库的真实世界注册

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-02-04 DOI:10.1016/j.conctc.2025.101446

Alexia Exarchos , Ariel B. Bourla , Maneet Kaur , Katja Schulze , Sophia Maund , Yi Cao , Yihua Zhao , Elizabeth H. Williams , Sarah C. Gaffey , Richard Zuniga , Shaily Lakhanpal , Vladan Antic , Michelle Doral , Johanna Sy , Neal J. Meropol , Anne C. Chiang

{"title":"使用实用技术支持平台的前瞻性临床基因组数据库的真实世界注册","authors":"Alexia Exarchos , Ariel B. Bourla , Maneet Kaur , Katja Schulze , Sophia Maund , Yi Cao , Yihua Zhao , Elizabeth H. Williams , Sarah C. Gaffey , Richard Zuniga , Shaily Lakhanpal , Vladan Antic , Michelle Doral , Johanna Sy , Neal J. Meropol , Anne C. Chiang","doi":"10.1016/j.conctc.2025.101446","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Discovery and incorporation of predictive and prognostic biomarkers enhance outcomes for patients with cancer. Clinico-genomic datasets, which retrospectively link real-world clinical data to tumor sequencing data, are important resources for biomarker research, which has historically relied on robust research infrastructures exclusive to large academic centers. The objective was to evaluate the feasibility of a pragmatic, technology-enabled platform at community-based research sites for development of a prospective clinico-genomic database supported by centralized electronic health record (EHR)–based patient ascertainment and data processing.</div></div><div><h3>Methods</h3><div>Adults with stage IV or recurrent metastatic non-small cell lung cancer or extensive-stage small-cell lung cancer were enrolled at 23 US sites upon initiating a standard line of therapy. Enrollment rates were estimated from eligible populations at individual centers. Clinical data from routinely collected EHR documentation were centrally processed and normalized for quality control. Serial blood samples at pre-specified timepoints (baseline, during treatment and at disease progression/end of therapy) were used for circulating tumor DNA (ctDNA) genomic profiling.</div></div><div><h3>Results</h3><div>Between December 2019 and May 2021, 944 patients enrolled, representing ≈25 % of eligible patients. Eight-hundred seventeen of 944 (87 %), 406 of 606 (67 %) and 398 of 852 (47 %) participants provided qualifying samples for ctDNA testing at baseline, during treatment and at disease progression/end of therapy, respectively. Samples were provided at all three timepoints by 35 % of participants.</div></div><div><h3>Conclusion</h3><div>A community-based oncology patient cohort was rapidly enrolled, creating a real-world clinico-genomic dataset. This pragmatic study platform has potential research applications where prospective real-world data may contribute to evidence generation.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101446"},"PeriodicalIF":1.4000,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Real-world enrollment for a prospective clinico-genomic database using a pragmatic technology-enabled platform\",\"authors\":\"Alexia Exarchos , Ariel B. Bourla , Maneet Kaur , Katja Schulze , Sophia Maund , Yi Cao , Yihua Zhao , Elizabeth H. Williams , Sarah C. Gaffey , Richard Zuniga , Shaily Lakhanpal , Vladan Antic , Michelle Doral , Johanna Sy , Neal J. Meropol , Anne C. Chiang\",\"doi\":\"10.1016/j.conctc.2025.101446\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>Discovery and incorporation of predictive and prognostic biomarkers enhance outcomes for patients with cancer. Clinico-genomic datasets, which retrospectively link real-world clinical data to tumor sequencing data, are important resources for biomarker research, which has historically relied on robust research infrastructures exclusive to large academic centers. The objective was to evaluate the feasibility of a pragmatic, technology-enabled platform at community-based research sites for development of a prospective clinico-genomic database supported by centralized electronic health record (EHR)–based patient ascertainment and data processing.</div></div><div><h3>Methods</h3><div>Adults with stage IV or recurrent metastatic non-small cell lung cancer or extensive-stage small-cell lung cancer were enrolled at 23 US sites upon initiating a standard line of therapy. Enrollment rates were estimated from eligible populations at individual centers. Clinical data from routinely collected EHR documentation were centrally processed and normalized for quality control. Serial blood samples at pre-specified timepoints (baseline, during treatment and at disease progression/end of therapy) were used for circulating tumor DNA (ctDNA) genomic profiling.</div></div><div><h3>Results</h3><div>Between December 2019 and May 2021, 944 patients enrolled, representing ≈25 % of eligible patients. Eight-hundred seventeen of 944 (87 %), 406 of 606 (67 %) and 398 of 852 (47 %) participants provided qualifying samples for ctDNA testing at baseline, during treatment and at disease progression/end of therapy, respectively. Samples were provided at all three timepoints by 35 % of participants.</div></div><div><h3>Conclusion</h3><div>A community-based oncology patient cohort was rapidly enrolled, creating a real-world clinico-genomic dataset. This pragmatic study platform has potential research applications where prospective real-world data may contribute to evidence generation.</div></div>\",\"PeriodicalId\":37937,\"journal\":{\"name\":\"Contemporary Clinical Trials Communications\",\"volume\":\"44 \",\"pages\":\"Article 101446\"},\"PeriodicalIF\":1.4000,\"publicationDate\":\"2025-02-04\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Contemporary Clinical Trials Communications\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2451865425000201\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary Clinical Trials Communications","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2451865425000201","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}

引用次数: 0

摘要

背景：发现和纳入预测性和预后生物标志物可提高癌症患者的预后。临床基因组数据集将现实世界的临床数据与肿瘤测序数据回顾性地联系起来，是生物标志物研究的重要资源，而生物标志物研究历来依赖于大型学术中心独有的强大研究基础设施。目的是评估在基于社区的研究站点建立一个实用的、技术支持的平台的可行性，该平台用于开发基于集中电子健康记录（EHR）的患者确定和数据处理支持的前瞻性临床基因组数据库。方法：在开始标准治疗线后，在美国23个地点招募了IV期或复发性转移性非小细胞肺癌或广泛期小细胞肺癌的成年人。从各个中心的符合条件的人群中估计入学率。常规收集的EHR文件中的临床数据被集中处理并规范化以进行质量控制。在预先指定的时间点（基线、治疗期间和疾病进展/治疗结束时）采集系列血液样本用于循环肿瘤DNA （ctDNA）基因组分析。在2019年12月至2021年5月期间，944名患者入组，占符合条件患者的约25%。944名参与者中有817名（87%），606名参与者中有406名（67%），852名参与者中有398名（47%）分别在基线、治疗期间和疾病进展/治疗结束时提供了合格的ctDNA检测样本。35%的参与者在所有三个时间点提供了样本。基于社区的肿瘤患者队列快速入组，创建了真实世界的临床基因组数据集。这个实用的研究平台具有潜在的研究应用，其中潜在的现实世界数据可能有助于证据生成。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

Real-world enrollment for a prospective clinico-genomic database using a pragmatic technology-enabled platform

Background

Discovery and incorporation of predictive and prognostic biomarkers enhance outcomes for patients with cancer. Clinico-genomic datasets, which retrospectively link real-world clinical data to tumor sequencing data, are important resources for biomarker research, which has historically relied on robust research infrastructures exclusive to large academic centers. The objective was to evaluate the feasibility of a pragmatic, technology-enabled platform at community-based research sites for development of a prospective clinico-genomic database supported by centralized electronic health record (EHR)–based patient ascertainment and data processing.

Methods

Adults with stage IV or recurrent metastatic non-small cell lung cancer or extensive-stage small-cell lung cancer were enrolled at 23 US sites upon initiating a standard line of therapy. Enrollment rates were estimated from eligible populations at individual centers. Clinical data from routinely collected EHR documentation were centrally processed and normalized for quality control. Serial blood samples at pre-specified timepoints (baseline, during treatment and at disease progression/end of therapy) were used for circulating tumor DNA (ctDNA) genomic profiling.

Results

Between December 2019 and May 2021, 944 patients enrolled, representing ≈25 % of eligible patients. Eight-hundred seventeen of 944 (87 %), 406 of 606 (67 %) and 398 of 852 (47 %) participants provided qualifying samples for ctDNA testing at baseline, during treatment and at disease progression/end of therapy, respectively. Samples were provided at all three timepoints by 35 % of participants.

Conclusion

A community-based oncology patient cohort was rapidly enrolled, creating a real-world clinico-genomic dataset. This pragmatic study platform has potential research applications where prospective real-world data may contribute to evidence generation.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.