PO.CTP01.03 · 进行中的临床试验

消防员职业性癌症筛查:一项全身筛查方式的先导性随机研究

Occupational cancer screening in firefighters: A pilot randomized study of whole-body screening modalities

编号 CT210 展板 5 时间 4/21 09:00–12:00 区域 Section 51 主讲 Bryan Bassig, PhD
分会场 Phase II and Phase III Clinical Trials in Progress
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作者与单位 Authors & Affiliations

Bryan Bassig, Jennifer Lund, John F. Deeken, Salman Baig, Blair Allais, Rita Stanislawski, Megan Slocum, Elizabeth Hatcher, Jennifer Truax, Inger Rosner, Rebecca Kaltman

Inova Health System, Fairfax, VA

摘要 Abstract

中文摘要
背景:国际癌症研究机构已得出结论,消防员的职业工作具有致癌性。鉴于消防员罹患多种癌症类型的风险较高,提供基于证据的预防性健康服务(包括癌症筛查建议)势在必行。关于消防员最佳筛查方法的循证数据和建议,以及对消防员在真实世界实践中已经接受的较新筛查方式(如全身影像学和多癌种检测血液[MCD]检测)的风险与获益的理解,仍然有限且亟需。本先导性癌症筛查试验旨在生成关于使用全身影像学和MCD检测对消防员进行癌症筛查的临床效用和影响的初步数据,并评估这些筛查工具所导致的下游医疗资源利用和诊断检测。 方法:本试验的入选标准包括:北弗吉尼亚州年龄≥35岁、服务至少10年、且过去5年内未患癌症、过去一年内未接受任何全身筛查方式检测的消防员。参与者被均等随机分配接受全身MRI或全身超声,所有参与者均接受MCD检测。使用一种经验证的全身MRI筛查风险分层方法(ONCO-RADS),根据癌症可能性评估所见,以指导临床随访决策。全身超声报告由一组临床研究者评估,按器官系统将所见风险分层为正常、临床可采取行动/不怀疑癌症或临床可采取行动/怀疑恶性肿瘤。MCD检测阳性的参与者接受详细的临床评估,随后进行进一步诊断检查。影像检查后,参与者与临床研究者会面,审查所见及推荐的诊断随访(如有必要)。鼓励参与者完成与年龄相适应的标准治疗筛查,并为其提供全身皮肤检查以及三维全身摄影。符合NCCN标准者可获得遗传咨询和检测。在影像检查后一年联系参与者完成一项癌症结局调查。对于每个筛查组,将计算相对于筛查人数的确诊恶性肿瘤的数量和比例,以及其他临床影响指标,如假阳性比例和所需诊断随访的评估。本先导研究的结果将支持开展一项更大规模的试验,以评估新兴筛查方式的风险和获益,并为消防员提供一种标准化的、基于证据的筛查方法。入组始于2025年2月。截至2025年12月,约450名(计划800名中)参与者已入组,预计于2026年夏季完成(NCT06931561)。
查看英文原文 English abstract
Background: The International Agency for Research on Cancer has concluded that occupational work as a firefighter is carcinogenic. Given the higher risk of multiple cancer types in firefighters, providing evidence-based preventive health services including recommendations on cancer screening is imperative. Evidence-based data and recommendations on the optimal screening approach for firefighters and understanding risks and benefits of newer screening modalities that firefighters are already receiving in real-world practice, such as whole-body imaging and multi-cancer detection blood (MCD) tests, are limited and needed. This pilot cancer screening trial aims to generate preliminary data on the clinical utility and impact of using whole-body imaging and MCD testing for cancer screening in firefighters, and to evaluate the downstream healthcare utilization and diagnostic testing that results from these screening tools. Methods: Eligibility for this trial includes firefighters in Northern Virginia who are ≥ 35 years old with at least 10 years of service and who have not had cancer within the past 5 years or testing with any of the whole-body screening modalities in the past year. Participants are randomized equally to receive either a whole-body MRI or whole-body ultrasound and all participants receive MCD testing. A validated risk stratification approach (ONCO-RADS) for whole-body MRI screening that evaluates findings based on the likelihood of cancer is used to guide clinical follow-up decisions. Whole-body ultrasound reports are evaluated by a team of clinical investigators to risk stratify findings by organ system as either normal, clinically actionable/not suspicious for cancer, or clinically actionable/suspicious for malignancy. Participants with a positive MCD test undergo a detailed clinical evaluation followed by further diagnostic work-up. After imaging, participants meet with a clinical investigator to review findings and recommended diagnostic follow-up, if warranted. Participants are encouraged to complete age-appropriate standard of care screenings and are offered a total body skin examination along with three-dimensional total-body photography. Those meeting NCCN criteria are offered genetic counseling and testing. Participants are contacted to complete a cancer outcomes survey one year following their imaging. For each screening arm, the number and proportion of confirmed malignancies relative to the number screened will be calculated, as well as other measures of clinical impact such as the proportion of false-positives and an evaluation of the diagnostic follow-up needed. Results from this pilot will support development of a larger trial to evaluate risks and benefits of emerging screening modalities and provide a standardized and evidence-based screening approach for firefighters. Enrollment began in February 2025. Around 450 (of 800 planned) participants have enrolled as of December 2025, with anticipated completion in summer 2026 (NCT06931561).
利益披露 Disclosure
B. Bassig, Exact Sciences Other, Company conducting contracted lab services for trial on behalf on sponsor (Inova). Prenuvo Other, Company conducting contracted whole-body imaging services for trial on behalf of sponsor (Inova). United Diagnostic Services Other, Company conducting contracted whole-body imaging services for trial on behalf of sponsor (Inova). J. Lund, None.. J. F. Deeken, None.. S. Baig, None.. B. Allais, None.. R. Stanislawski, None.. M. Slocum, None.. E. Hatcher, None.. J. Truax, None.. I. Rosner, None. R. Kaltman, Exact Sciences Other, Conducting contracted lab services for study on behalf of sponsor (Inova). Prenuvo Other, Conducting contracted imaging services for study on behalf of sponsor (Inova). United Diagnostic Services Other, Conducting contracted imaging services for study on behalf of sponsor (Inova).

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