Burn Pit Exposure in Veterans: A Cancer Screening Pilot Study at the Inova Saville Cancer Screening & Prevention Center
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- STAI Questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 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
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: Avantect Multi-Cancer Detection Test (Device)
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).
干预措施: Nasal Swab (Diagnostic Test)
结局指标
主要结局
STAI Questionnaire
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- Nasal Swab(1 day)
- Blood Collection - Multi-cancer detection Blood Test(3 years)
- Radiomic analysis(2 years)