Department of Medicine, Division of Hematology/Oncology, University of California San Francisco, San Francisco, CA; Helen Diller Family Comprehensive Cancer Center, San Francisco, CA.
Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA; Greater Bay Area Cancer Registry, University of California San Francisco, San Francisco, CA.
Urol Oncol. 2021 Aug;39(8):494.e7-494.e14. doi: 10.1016/j.urolonc.2020.12.010. Epub 2021 Jan 5.
Racial/ethnic diversity in prostate cancer (CaP) clinical trials (CTs) is essential to address CaP disparities. California Cancer Registry mandated electronic reporting (e-path) of structured data elements from pathologists diagnosing cancer thereby creating an opportunity to identify and approach patients rapidly. This study tested the utility of an online CT matching tool (called Trial Library) used in combination with e-path to improve matching of underrepresented CaP patients into CTs at time of diagnosis.
This was a nonrandomized, single-arm feasibility study among patients with a new pathologic diagnosis of high-risk CaP (Gleason Score ≥8). Eligible patients were sent recruitment materials and enrolled patients were introduced to Trial Library.
A total of 419 case listings were assessed. Patients were excluded due to physician contraindication, not meeting baseline eligibility, or unable to be reached. Final participants (N = 52) completed a baseline survey. Among study participants, 77% were White, 10% were Black/Hispanic/Missing, and 14% were Asian. The majority of the study participants were over 65 years of age (81%) and Medicare insured (62%). Additionally, 81% of participants reported using the Internet to learn about CaP. The majority (62%) of participants reported that Trial Library increased their interest in CT participation.
The current study demonstrated that leveraging structured e-path data reporting to a population-based cancer registry to recruit men with high risk CaP to clinical research is feasible and acceptable. We observed that e-path may be linked with an online CT matching tool, Trial Library. Future studies will prioritize recruitment from reporting facilities that serve more racially/ethnically diverse patient populations.
前列腺癌（CaP）临床试验（CTs）中的种族/民族多样性对于解决 CaP 差异至关重要。加利福尼亚癌症登记处要求病理学家诊断癌症时进行电子报告（e-path），从而提供了快速识别和接触患者的机会。本研究测试了一种在线 CT 匹配工具（称为“试验库”）的实用性，该工具与 e-path 结合使用，以提高诊断时代表性不足的 CaP 患者入组 CT 的匹配率。
这是一项针对新诊断为高危前列腺癌（Gleason 评分≥8）的患者的非随机、单臂可行性研究。合格的患者会收到招募材料，已入组的患者会被介绍使用“试验库”。
共评估了 419 例病例列表。由于医生禁忌、不符合基线资格或无法联系到患者，患者被排除在外。最终的参与者（N=52）完成了基线调查。在研究参与者中，77%是白人，10%是黑人/西班牙裔/其他/缺失，14%是亚洲人。研究参与者中大多数（81%）年龄超过 65 岁，62%有医疗保险。此外，81%的参与者表示曾使用互联网了解 CaP。大多数（62%）参与者表示，“试验库”增加了他们对参加 CT 的兴趣。
本研究表明，利用基于人群的癌症登记处的结构化 e-path 数据报告招募患有高危 CaP 的男性参加临床研究是可行且可接受的。我们观察到，e-path 可能与在线 CT 匹配工具“试验库”相关联。未来的研究将优先从服务于更多种族/民族多样化患者群体的报告机构招募患者。
