CancerNCT07485322
Burn Pit Exposure in Veterans: A Cancer Screening Pilot Study at the Inova Saville Cancer Screening & Prevention Center
A study testing Avantect Multi-Cancer Detection Test and Nasal Swab in people with Cancer, run by Inova Health Care Services at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Avantect Multi-Cancer Detection Test and Nasal Swab
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2026to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Saville Research, 571-472-3500, Saville_Research@inova.org
Rebecca Kaltman, MD
About this study
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Avantect Multi-Cancer Detection Test, Nasal Swab
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avantect Multi-Cancer Detection TestDevice
Also called MCD
Multi-cancer blood test to detect cancer DNA. Manufactured by ClearNote Health.
Nasal SwabDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Veterans exposed to burn pits | Experimental | 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). Receives: Device: Avantect Multi-Cancer Detection Test; Diagnostic Test: Nasal Swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 2 years
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start17 Jun 2026
- Primary completion28 Apr 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Kaltman, MD, Principal investigator, Inova Health Care ServicesStephanie VanBebber, Study director, Inova Health Care Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485322
- Sponsor's protocol ID
- INOVA-2025-302
- Status last verified
- Jun 2026
- First submitted
- 3 Mar 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burn Pit Exposure in Veterans: A Cancer Screening Pilot Study at the Inova Saville Cancer Screening & Prevention Center
- ClinicalTrials.gov ID
- NCT07485322
- Acronym / sponsor ID
- INOVA-2025-302
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Study start
- 17 Jun 2026 (actual)
- Primary completion
- 28 Apr 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Veterans exposed to burn pits | Experimental | Device: Avantect Multi-Cancer Detection Test, Diagnostic Test: Nasal SwabVeteran 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). |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avantect Multi-Cancer Detection TestAlso: MCDMulti-cancer blood test to detect cancer DNA. Manufactured by ClearNote Health. | Device | Veterans exposed to burn pits |
| Nasal SwabTwo 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. | Diagnostic test | Veterans exposed to burn pits |
Primary outcome
STAI Questionnaire
Time frame: 3.5 years
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.
Burn Pit Exposure Questionnaire
Time frame: 1 day
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
Cancer Outcomes Follow up Questionnaire
Time frame: 1 day
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.
Intensive Cancer Screening Feasibility
Time frame: 2 years
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
3 secondary outcomes
Nasal Swab
Time frame: 1 day
Blood Collection - Multi-cancer detection Blood Test
Time frame: 3 years
Radiomic analysis
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- US Dept of Veterans Affairs: Airborne Hazards and Burn Pit ExposuresLink provided by the sponsor.
- US EPA: Health and environmental effects of particulate (PM)Link provided by the sponsor.
- US EPA: Integrated Science Assessment for Particulate MatterLink provided by the sponsor.
- American Cancer Society: Military Burn Pits and Cancer RiskLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
Related trials for Cancer
Not yet recruiting
Using e-Technologies to Maximize Physical Activity After Cancer Treatment
Cancer
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Pharmacogenetic Determinants Of Treatment Response In Children
All Malignancies, Children Being Treated for Catastrophic Illness
RecruitingObservational study
Cancer in Inherited Bone Marrow Failure Syndromes
Diamond Blackfan Anemia, Dyskeratosis Congenita
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rebecca Kaltman, MD principal investigator
Inova Health Care Services
Stephanie VanBebber study director
Inova Health Care Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avantect Multi-Cancer Detection Test and Nasal Swab in people with Cancer, run by Inova Health Care Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bryan Bassig, PhD ((571) 472-3500, bryan.bassig@inova.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
STAI Questionnaire (time frame: 3.5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.