Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, United States of America; Present affiliation: Medicines360, 353 Sacramento Street, Suite 300, San Francisco, CA, United States of America.
Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, DHHS, 9609 Medical Center Drive, MSC 9776 Bethesda, MD, United States of America.
J Clin Virol. 2021 Dec;145:105014. doi: 10.1016/j.jcv.2021.105014. Epub 2021 Nov 3.
Biomarkers of Human Papillomavirus (HPV) cervical carcinogenesis are critical to address questions of how to triage and manage women who screen positive for high-risk HPV (HrHPV) and identify those at highest cancer risk.
We describe the development of a large biorepository of cervical specimens for the Improving Risk Informed HPV Screening Study (IRIS) using residual specimens collected in the regional laboratory from women aged 25 and older who had cervical cancer screening or follow-up testing with high-risk human papillomavirus (HrHPV) testing and liquid-based cytology (co-testing) at Kaiser Permanente Northern California (KPNC) from January 2016 to August 2018. Specimen selection, processing for long-term storage, follow-up tracking, consent and demographic and clinical characteristics of the women in the IRIS cohort are described.
Selecting from 897,680 women who had at least one co-test during the study period, we collected 199,403 baseline and 216,390 follow-up HrHPV and cytology specimens from a stratified random sample of 81,348 women, of which 3,428 (4.2%) opted out of the study and were excluded. The majority (79.9%) of the baseline specimens were from HrHPV-positive women. The mean age was 36 years, and the cohort is racially/ethnically diverse with 56% of women being Hispanic or non-white. Over two-thirds of the cohort were members of KPNC for two or more years prior to inclusion. Of the 77,920 women included in the cohort, 57,414 (73.7%) had at least one follow-up co-test.
Use of specimens from the biorepository will elucidate molecular mechanisms underlying HPV carcinogenesis and inform more effective screening and follow-up strategies.
人乳头瘤病毒（HPV）宫颈癌发生的生物标志物对于解决如何对高危型 HPV（HrHPV）检测阳性的女性进行分类管理，以及确定癌症风险最高的人群的问题至关重要。
我们描述了一个大型宫颈标本生物库的开发，用于改善 HPV 风险知情筛查研究（IRIS），该生物库使用了 Kaiser Permanente Northern California（KPNC）地区实验室从 2016 年 1 月至 2018 年 8 月收集的剩余标本，这些标本来自年龄在 25 岁及以上的女性，她们接受了宫颈癌筛查或随访检测，包括高危型人乳头瘤病毒（HrHPV）检测和液基细胞学（联合检测）。描述了 IRIS 队列中女性的标本选择、长期储存处理、随访跟踪、同意以及人口统计学和临床特征。
在研究期间，我们从至少进行过一次联合检测的 897680 名女性中选择，从分层随机抽取的 81348 名女性中收集了 199403 份基线和 216390 份随访的 HrHPV 和细胞学标本，其中 3428 名（4.2%）选择退出研究而被排除。基线标本的大多数（79.9%）来自 HrHPV 阳性女性。平均年龄为 36 岁，队列的种族/民族多样化，其中 56%的女性为西班牙裔或非白人。在纳入该队列之前，超过三分之二的女性已经是 KPNC 的成员两年或更长时间。在 77920 名纳入该队列的女性中，有 57414 名（73.7%）至少有一次随访联合检测。
使用生物库标本将阐明 HPV 致癌的分子机制，并为更有效的筛查和随访策略提供信息。
