Cancer
Conditions
Brief 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. 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.
Interventions
DEVICEAvantect Multi-Cancer Detection Test
Multi-cancer blood test to detect cancer DNA. Manufactured by ClearNote Health.
DIAGNOSTIC_TESTNasal 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.
Sponsors
Inova Health Care Services
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 85 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| STAI Questionnaire | 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 | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nasal Swab | 1 day | 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. |
| Blood Collection - Multi-cancer detection Blood Test | 3 years | 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. |
| Radiomic analysis | 2 years | 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. |
Countries
United States
Contacts
CONTACTBryan Bassig, PhD
CONTACTSalman Baig
PRINCIPAL_INVESTIGATORRebecca Kaltman, MD
Inova Health Care Services
STUDY_DIRECTORStephanie VanBebber
Inova Health Care Services
Outcome results
None listed