跳至主要内容
临床试验/NCT06931561
NCT06931561招募中不适用

Occupational Cancer Screening in Firefighters: A Pilot Study Within the Inova Health System

Inova Health Care Services2 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2025年2月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
800
试验地点
2
主要终点
Number of confirmed pre-malignancies detected with each investigational screening tool

研究概览

简要总结

The purpose of this study is to further understand the clinical impact and follow-up steps that may be required based on using whole-body Magnetic Resonance Imaging (MRI) or whole-body ultrasound and blood tests to detect multiple cancers in firefighters.

This study involves an investigational test (cancer blood test) that has not been approved by the U.S. Food and Drug Administration (FDA).

Whole-body MRI and whole-body ultrasound are approved by the U.S. Food and Drug Administration (FDA) to be used in the diagnosis of some cancers and is approved for adults and children who present other signs of potential disease. In this study, however, the whole-body MRI and the whole-body ultrasound are considered investigational devices because they are not yet approved for use in healthy adults with no other cancer indications.

详细描述

In July 2022, a Working Group of the International Agency for Research on Cancer (IARC) concluded that occupational work as a firefighter is carcinogenic to humans (Group 1) based on a comprehensive review of the scientific literature. Given the established higher risk of multiple cancer types in firefighters, an emphasis on evaluating and delivering evidence-based preventive health services including screening for early detection of cancer in this population is imperative. Evidence-based recommendations on the optimal screening approach for firefighters at higher risk of cancer and greater understanding of the risks and benefits of investigational screening modalities that firefighters are currently receiving in real-world practice are needed. As part of a multidisciplinary cancer screening program for firefighters that is being conducted by the Saville Cancer Screening and Prevention Center and Department of Occupational Health within the Inova Health System, the purpose of this research study is to generate preliminary data on the clinical impact of investigational cancer screening modalities in 800 career and volunteer firefighters age ≥ 35 years old with at least 10 cumulative years of employment as a firefighter. Participating firefighters will be randomized equally to one of two whole-body imaging screening arms (1. whole body MRI, 2. whole body ultrasound) and all participants will further be screened with a multi-cancer detection assay. Aims include evaluating the clinical impact and performance of each tool in detecting cancer, the diagnostic follow-up and healthcare utilization prompted by use of each investigational tool, and assessments of anxiety and feasibility of implementation related to the screening protocols in participants. It is anticipated that results from this pilot will support the development of future firefighter cancer screening programs and serve as a research framework that can be adopted and tested within other health systems in partnership with the local fire jurisdictions in their catchment area, with the ultimate goal of identifying the risks and benefits of these tools for early cancer detection in the firefighter population.

All whole-body MRI examinations will be conducted without contrast using 1.5T (T is a unit of measure for magnetic field strength) (Tesla) MRI systems (Philips Healthcare Clinical Systems, Amsterdam, Netherlands). Scans will be obtained at an outpatient MRI facility with the images subsequently reviewed and reported by the imaging center radiologists specialized in the practice of preventive healthcare screening using whole-body MRI. The scan protocol that will be used for this research study is designed to be consistent with the protocol that has been implemented at external imaging centers such as Prenuvo where firefighters are already being screened. The resulting whole-body MRI report and images will be sent to the Saville clinical team who will use the report from the consulting radiologist to determine the follow-up diagnostic plan, as appropriate. The imaging report will include an interpretation of findings from each organ system with an assessment based on the Oncologically Relevant Findings Reporting and Data System (ONCO-RADS) along with any applicable clinical notes from the reviewing radiologist.

Whole-Body Ultrasound:

All whole-body ultrasound examinations will be conducted by a vendor that specializes in ultrasound diagnostics using the Mindray Z60 ultrasound technology with site-specific presets. The procedure will include scans of the liver, spleen, gallbladder, kidneys, thyroid (scanning of the right and left lobes of the gland to evaluate any nodules or echotexture changes), heart, and bladder. For female patients, further evaluation of the reproductive system including the uterus and ovaries will be assessed transabdominally while the urinary bladder is at its fullest capacity. For male patients, imaging of the testicles and surrounding region will also be performed. Any abnormality detected during the scan will be imaged multiple times with and without color (color imaging is used to show vascularity in the region where an abnormality is noted). Identical protocols and procedures for this scan will be used for all participants randomized to receive wholebody ultrasound and will be performed by the same imaging company. Unified Diagnostic Services (UDS), the ultrasound vendor, will provide the mobile ultrasounds at a location convenient to the participants, which could include the Saville Cancer Screening and Prevention Center, an Inova Occupational Health location, or directly at the firehouse or other convenient community location of a participating jurisdiction.

Multiple Cancer Detection (MCD) Test:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Screening
盲法
Single (Investigator)

入排标准

年龄范围
35 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 35 years old
  • at least 10 cumulative years working as a firefighter
  • Actively serving as a firefighter (active or volunteer) with completion of NFPA physical examination within the past 6 months
  • Ability to understand and willing to sign informed consent
  • Ability to understand and willing to sign the Health Insurance Portability and Accountability Act (HIPAA) Authorization
  • Additional eligibility criteria in protocol

排除标准

  • No prior history of any invasive cancer within the previous 5 years (non-melanoma skin cancer and in situ carcinoma would still be eligible) and no current diagnostic workup for suspicion of cancer
  • Received a whole-body MRI, whole-body ultrasound, or been tested with a MCD within the past 1-year
  • For women of childbearing potential, pregnancy and no plans for pregnancy for the duration of the study
  • Additional exclusion criteria in protocol

研究组 & 干预措施

Whole Body MRI

Active Comparator

Prenuvo whole body magnetic resonance imaging

干预措施: Occupational Exposure Questionnaire (Other)

Whole Body MRI

Active Comparator

Prenuvo whole body magnetic resonance imaging

干预措施: Whole Body MRI (Procedure)

Whole Body Ultrasound

Active Comparator

High frequency sound waves

干预措施: Whole Body Ultrasound (Procedure)

Whole Body Ultrasound

Active Comparator

High frequency sound waves

干预措施: MCD Assay (Device)

Whole Body Ultrasound

Active Comparator

High frequency sound waves

干预措施: Occupational Exposure Questionnaire (Other)

Whole Body MRI

Active Comparator

Prenuvo whole body magnetic resonance imaging

干预措施: MCD Assay (Device)

结局指标

主要结局

Number of confirmed pre-malignancies detected with each investigational screening tool

时间窗: up to 1 year (± 2 months)

The number of confirmed pre-malignancies detected using whole-body Magnetic Resonance Imaging (MRI), whole-body ultrasound, or the Multi Cancer Detection (MCD) test

Number of confirmed malignancies detected with each investigational screening tool

时间窗: up to 1 year (± 2 months)

The number of confirmed malignancies detected using whole-body Magnetic Resonance Imaging (MRI), whole-body ultrasound, or the Multi Cancer Detection (MCD) test

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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