Hedges Joanne, Sethi Sneha, Garvey Gail, Whop Lisa J, Canfell Karen, Dodd Zell, Larkins Priscilla, Antonsson Annika, Smith Megan A, Mittinty Murthy, Leane Catherine, Reid Nicolas, Ooi Eng H, Ju Xiangqun, Logan Richard, Jamieson Lisa
Australian Research Centre for Population Oral Health, Adelaide Dental School, The University of Adelaide, Adelaide, Australia.
Epidemiology and Health Systems, Menzies School of Health Research, University of Queensland, Brisbane, Australia.
JMIR Res Protoc. 2023 May 17;12:e44593. doi: 10.2196/44593.
Human papillomavirus (HPV) infection, a common sexually transmitted disease, is associated with cancers of the cervix, vulva, vagina, penis, anus, and head and neck. Oropharyngeal squamous cell carcinoma (OPSCC; throat cancer) is a type of cancer involving the head and neck area that is rapidly increasing across the globe. There are higher rates of OPSCC among Indigenous populations relative to non-Indigenous Australian populations, although the HPV-attributable fraction remains unknown. For the first time at a global level, we plan to extend an Indigenous Australian adult cohort to monitor, screen, and ultimately prevent HPV-associated OPSCC and to undertake extensive cost-effectiveness modelling around HPV vaccination.
This study aims to (1) extend follow-up to a minimum of 7 years post recruitment to describe the prevalence, incidence, clearance, and persistence of oral HPV infection; and (2) conduct clinical examinations of the head and neck, oral cavity, and oropharynx and collect saliva samples for early-stage OPSCC testing.
We will continue to implement a longitudinal design for the next study phase, where we will ascertain the prevalence, incidence, clearance, and persistence of oral HPV infection at 48, 60, and 72 months; undertake clinical examinations/saliva assessments to detect early-stage OPSCC; and refer for treatment. The primary outcome measures are changes in oral HPV infection status, biomarker measures of early HPV-related cancer, and clinical evidence of early-stage OPSCC.
Participant 48-month follow-up will commence in January 2023. The first results are expected to be submitted for publication 1 year after 48-month follow-up begins.
Our findings have potential to change the way in which OPSCC among Australian Indigenous adults is managed, with desired impacts including cost-savings on expensive cancer treatments; improved nutritional, social, and emotional outcomes; and improved quality of life for both Indigenous adults and the Indigenous community more broadly. Continuing a large, representative Indigenous adult cohort to track oral HPV infection and monitor early OPSCC is essential to yield critical information to include in the management armamentarium of health and well-being recommendations for Australia's First Nations.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/44593.
人乳头瘤病毒（HPV）感染是一种常见的性传播疾病，与宫颈癌、外阴癌、阴道癌、阴茎癌、肛门癌以及头颈癌有关。口咽鳞状细胞癌（OPSCC；咽喉癌）是一种累及头颈区域的癌症，在全球范围内发病率正在迅速上升。相对于澳大利亚非原住民人群，原住民人群中OPSCC的发病率更高，尽管HPV归因比例尚不清楚。我们计划在全球范围内首次扩大澳大利亚原住民成人队列，以监测、筛查并最终预防HPV相关的OPSCC，并围绕HPV疫苗接种开展广泛的成本效益建模。
本研究旨在（1）将随访延长至招募后至少7年，以描述口腔HPV感染的患病率、发病率、清除率和持续率；（2）对头颈、口腔和口咽进行临床检查，并收集唾液样本用于早期OPSCC检测。
在下一研究阶段，我们将继续采用纵向设计，确定48、60和72个月时口腔HPV感染的患病率、发病率、清除率和持续率；进行临床检查/唾液评估以检测早期OPSCC；并转诊进行治疗。主要结局指标为口腔HPV感染状态的变化、早期HPV相关癌症的生物标志物指标以及早期OPSCC的临床证据。
参与者的48个月随访将于2023年1月开始。预计在48个月随访开始1年后提交首批结果以供发表。
我们的研究结果有可能改变澳大利亚原住民成人OPSCC的管理方式，预期影响包括节省昂贵癌症治疗的费用；改善营养、社会和情感状况；以及更广泛地改善原住民成人和原住民社区的生活质量。继续维持一个大型、具有代表性的原住民成人队列来追踪口腔HPV感染并监测早期OPSCC，对于获取关键信息以纳入澳大利亚原住民健康与福祉建议的管理手段至关重要。
国际注册报告识别码（IRRID）：PRR1-10.2196/44593
