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

ConditionCancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-85
SponsorInova Health Care Services

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Whole Body MRI

    Procedure/Surgery

    Whole body MRI

  • Whole Body Ultrasound

    Procedure/Surgery

    Whole Body Ultrasound

  • MCD Assay

    Device

    Cancer detection blood test

  • Occupational Exposure Questionnaire

    Other intervention

    Questionnaire

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: Whole Body MRIActive comparator 3 interventions
Group B: Whole Body UltrasoundActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

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

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

Time frame
up to 1 year (± 2 months)
2

Number of confirmed malignancies detected with each investigational screening tool

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

Time frame
up to 1 year (± 2 months)

Secondary outcomes

Other outcomes

1

Sensitivity of each investigational screening tool

Sensitivity of each investigational screening tool (whole-body ultrasound, whole-body MRI, and MCD test)

Time frame
up to 1 year (± 2 months)
2

Specificity of each investigational screening tool

Specificity of each investigational screening tool (whole-body ultrasound, whole-body MRI, and MCD test)

Time frame
up to 1 year (± 2 months)
3

Negative predictive value (NPV) of each investigational screening tool

Negative predictive value (NPV) of each investigational screening tool (whole-body ultrasound, whole-body MRI, and MCD test)

Time frame
up to 1 year (± 2 months)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Inova Health Care Services

Lead sponsor

Virginia Department of Health

Collaborator

Source ClinicalTrials.gov
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