Burn Pit Exposure in Veterans: A Cancer Screening Pilot Study at the Inova Saville Cancer Screening & Prevention Center

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer
• Intervention / Treatment: Device: Avantect Multi-Cancer Detection Test; Diagnostic test: Nasal Swab

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Salman Baig; Phone Number: (571) 472-3500; Email: salman.baig@inova.org
• Study Contact Backup: Name: Bryan Bassig, PhD; Phone Number: (571) 472-3500; Email: bryan.bassig@inova.org

Study Locations

• United States
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Inova Schar Cancer Institute
      • Principal Investigator: Rebecca Kaltman, MD
      • Sub-Investigator: Bryan Bassig, PhD
      • Sub-Investigator: Jennifer Lund, DO
      • Contact: Saville Research; Phone Number: 571-472-3500; Email: Saville_Research@inova.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
STAI Questionnaire	Participant Satisfaction and psychosocial impact of cancer screening will be measured by the Anxiety and Satisfaction Survey. The STAI is a validated anxiety tool that has been used in a variety of research and clinical settings, including studies of cancer screening. The survey will be administered at the following timepoints: After enrollment, before each of the up to 8 screening procedures, after each screening procedure, and after the 1 year screening period. The state component of the questionnaire will be administered at the following timepoints: 12-month study visit, 24-month study visit, before each of the up to 8 screening procedures, after post results review from the previous screening assessment, and follow up (1 year + 2 months following the last screening assessment). STAI scores are computed on a scale from 20-80, with higher scores representing a higher degree of anxiety.	3.5 years
Burn Pit Exposure Questionnaire	This questionnaire will determine the demographic, clinical, lifestyle, and burn pit exposure characteristics of participants in the intensive cancer screening regimen. This questionnaire administered during baseline will assess the position, branch, and dates of military service for each participant and whether they were stationed, worked, and/or lived near a burn pit during those dates of service. The questionnaire will also include an assessment of the specific types of duties that the participant performed if working near the burn pit and how many hours they were exposed to smoke or fumes from the burn pit on a typical day. Participants' demographic, lifestyle and clinical, and burn pit exposure characteristics will be summarized using descriptive statistics	1 day
Cancer Outcomes Follow up Questionnaire	This questionnaire will describe the number, proportion, and stage of confirmed pre-malignant and malignant findings in veterans exposed to burn pits during each annual screening period and during follow-up for the intensive cancer screening protocol. This questionnaire is completed at 12 (+ 2) months following the 24-month screening assessment by phone or electronically. This questionnaire will assess information on any new diagnoses of cancer since the last screening visit. This information can also be collected from medical records without direct participant contact instead of questionnaire if available within the timeframe. The number, proportion, and type and stage of confirmed cancers, and participant demographic, lifestyle, and clinical characteristics will be summarized using descriptive statistics.	1 day
Intensive Cancer Screening Feasibility	Feasibility will be defined as 75% of enrolled participants completing at least 80% of the cancer screening assessments for which they are eligible during each screening period. Any adverse events resulting from the study procedures will be monitored by the research and clinical team during the study visits and will also be assessed during follow-up with participants when the results of screening examinations are provided. The assessments include: Laboratory assessments (CBC, CMP, TSH, LDH, PSA, urinalysis); ENT, skin (with Vectra), breast, and neurological exams; Pulmonary function test (PFT); Flexible Laryngoscopy; Stool-based colon cancer screening (age 35-44 years); Mammogram (women age 35-39); Low-dose CT scan of the chest; Brain MRI with contrast (only for those with abnormal neuro exam); Testicular ultrasound	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nasal Swab	As an exploratory objective, the study will use a nasal swab procedure to detect bronchial gene expression biomarkers. Molecular changes in the nasal epithelium can also serve as a tool for early detection of lung cancer. Two nasal brush swabs will be collected one time during the baseline screening period.	1 day
Blood Collection - Multi-cancer detection Blood Test	The assay involves the analysis of 5-hydroxymethylation (5hmC) of cell-free DNA (cfDNA) using next generation sequencing (NGS). A report indicating whether a cancer signal has been detected from analysis of the blood sample will be issued. For participants that do not have a cancer signal detected, no further diagnostic evaluations will be scheduled based on this particular screening test. For participants that have a cancer signal detected in their sample, the blood test report will additionally contain two tissue of origin (TOO) predictions, which may be used by the clinical research team to guide follow-up diagnostic steps. The test will be administered once a year for 3 years.	3 years
Radiomic analysis	The radionomic analysis will will describe the performance of this tool in detecting diagnoses of malignancy during the study screening and follow up period. These may include mammograms, low-dose CT scan, Brain MRI (if an abnormal neuro exam presents), and testicular ultrasound. An analysis of the LDCT images will be conducted using the machine learning program SYBIL, which is a publicly available program that is used to predict development of lung cancer. SYBIL predictive scores generated from the model will be summarized from LDCT images from each annual screening period for the study population. For any patients diagnosed with lung cancer, the distribution of SYBIL scores will be presented separately relative to patients that did not develop lung cancer. Exploratory analyses summarizing the SYBIL scores by select clinical and/or patient demographic/lifestyle data collected in the study will be conducted.	2 years

Collaborators and Investigators

• Sponsor: Inova Health Care Services
• Investigators: Principal Investigator: Rebecca Kaltman, MD, Inova Health Care Services; Study Director: Stephanie VanBebber, Inova Health Care Services

Publications and helpful links

Helpful Links

• US Dept of Veterans Affairs: Airborne Hazards and Burn Pit Exposures
• US EPA: Health and environmental effects of particulate (PM)
• US EPA: Integrated Science Assessment for Particulate Matter
• American Cancer Society: Military Burn Pits and Cancer Risk
• US CDC: HPV and Oropharyngeal Cancer

Study record dates

Study Major Dates

• Study Start (Estimated): May 2, 2026
• Primary Completion (Estimated): April 28, 2029
• Study Completion (Estimated): July 31, 2029

Study Registration Dates

• First Submitted: March 3, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: INOVA-2025-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All data and records generated during this study will be kept confidential in accordance with Inova Health System institutional policies and HIPAA on participant privacy. The Investigator and other site personnel will not use such data and records for any purpose other than conducting the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No