Mack Philip C, Crawford James M, Chang Andres, Yin Anna, Klein Sabra L, Shea Patrick, Hirsch Fred R, Zidar David, Simon Viviana, Gleason Charles, McBride Russell, Cordon-Cardo Carlos, VanOudenhove Jennifer, Halene Stephanie, Lee F Eun-Hyung, Mantis Nicholas, Kushi Lawrence H, Weiskopf Daniela, Merchant Akil, Reckamp Karen L, Skarbinski Jacek, Figueiredo Jane C
Center for Thoracic Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, United States.
Department of Pathology and Laboratory Medicine, Northwell Health, New Hyde Park, NY, United States.
J Natl Cancer Inst. 2025 Aug 1;117(8):1547-1556. doi: 10.1093/jnci/djaf073.
The COVID-19 pandemic created the urgent need to monitor risk of SARS-CoV-2 infection and mortality and to evaluate immune responses to novel vaccines. A foremost concern was the unknown risks to patients with cancer, considering their overall health, immune status, and interactions with cancer therapies. The US National Cancer Institute, in partnership with the National Institute of Allergy and Infectious Diseases, established the SARS-CoV-2 Serological Sciences Network as the nation's largest coordinated effort to identify and establish standardized serology tests to study immune responses against SARS-CoV-2. Serological Sciences Network-sponsored institutions established cohort studies in 2020 and 2021 across the nation to prospectively follow more than 3000 patients with solid and hematologic malignancies. Concerted efforts were launched to define common data elements for self-reported and clinicopathological data as well as standardized approaches for serological, cellular, and molecular assays. However, the urgency of the situation, the pace of scientific evolution, and the changing public health landscape presented unique challenges to this effort. Here, we discuss these challenges, including regulatory and institution-specific requirements, enrollment of participants, data and biospecimen collection and harmonization, and the need to adapt study designs to align with the ever changing landscape. This information is critical to the continuance of research on SARS-CoV-2 and provides a roadmap for combatting the emergence of future pathogens with pandemic potential.
新冠疫情使得监测严重急性呼吸综合征冠状病毒2（SARS-CoV-2）感染风险和死亡率以及评估新型疫苗的免疫反应成为当务之急。一个首要问题是，鉴于癌症患者的整体健康状况、免疫状态以及与癌症治疗的相互作用，他们面临的未知风险。美国国立癌症研究所与国立过敏与传染病研究所合作，建立了SARS-CoV-2血清学科学网络，这是美国最大规模的协同努力，旨在识别并建立标准化血清学检测方法，以研究针对SARS-CoV-2的免疫反应。血清学科学网络资助的机构在2020年和2021年在全国范围内开展了队列研究，以前瞻性地跟踪3000多名实体瘤和血液系统恶性肿瘤患者。各方共同努力，确定自我报告数据和临床病理数据的通用数据元素，以及血清学、细胞和分子检测的标准化方法。然而，形势的紧迫性、科学发展的速度以及不断变化的公共卫生格局给这项工作带来了独特的挑战。在此，我们讨论这些挑战，包括监管和机构特定要求、参与者招募、数据和生物样本采集与协调，以及根据不断变化的形势调整研究设计的必要性。这些信息对于SARS-CoV-2研究的持续进行至关重要，并为应对未来具有大流行潜力的病原体的出现提供了路线图。
