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Purpose

The goal of this study is to determine the feasibility and participant satisfaction associated with a more intensive cancer screening regimen in veterans exposed to burn pits. The study results may describe the clinical and psychosocial impact such screening has on this potential population. The study hopes to share the premalignant and malignant findings identified and follow-up healthcare utilization associated with high-intensity cancer screening during the approximately 3-year study period (three annual screening assessments and an additional year of follow-up to determine participants' cancer status). The study will also explore the performance of new tools (nasal brush, multi-cancer detection blood test, and radiomic analysis) in detecting the development of cancer during the study period.

Condition

Eligibility

Eligible Ages
Between 35 Years and 85 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • ≥ 35 years - Veteran of the United States Armed Forces (retired/no longer enlisted) with a prior deployment resulting in exposure (based on self-report or official records, if available) to burn pits for >1 week (exposure defined as on the base or close enough to the base to see the smoke from the burn pit, an area of land used for the open-air combustion of trash and other solid waste products). - Ability to understand and willing to sign informed consent - Ability to understand and willing to sign HIPAA Authorization

Exclusion Criteria

  • No history of malignancy within the past 5 years (non-melanoma skin cancer and in situ carcinoma would still be eligible) and not currently being worked up clinically for suspicion of cancer. - For women of childbearing potential, not pregnant.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Veterans exposed to burn pits 		Veteran of the United States Armed Forces (retired/no longer enlisted) with a prior deployment resulting in exposure (based on self-report or official records, if available) to burn pits for >1 week (exposure defined as on the base or close enough to the base to see the smoke from the burn pit, an area of land used for the open-air combustion of trash and other solid waste products).
  • Device: Avantect Multi-Cancer Detection Test
    Multi-cancer blood test to detect cancer DNA. Manufactured by ClearNote Health.
    Other names:
    • MCD
  • Diagnostic Test: Nasal Swab
    Two nasal brush swabs will be collected during the baseline screening period. The brushing of the inside of the nose is performed using a soft brush, with local anesthetic if necessary.

Recruiting Locations

Inova Schar Cancer Institute
Fairfax, Virginia 22031
Contact:
Saville Research
571-472-3500
Saville_Research@inova.org

More Details

Status
Recruiting
Sponsor
Inova Health Care Services

Study Contact

Bryan Bassig, PhD
(571) 472-3500
bryan.bassig@inova.org

Detailed Description

Participants are assigned by the study protocol to intensive cancer screening at baseline, 12-, and 24-month visits, with follow-up at 36 months. All procedures, including investigational tools like the MCD blood test and nasal swabs, are required by the study and are not routine clinical care. The study objectives include: feasibility, participant satisfaction, detection of cancer, follow-up care, and testing of investigational tools. This is an interventional study.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.