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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Avantect Multi-Cancer Detection Test
  Multi-cancer blood test to detect cancer DNA. Manufactured by ClearNote Health.
• Диагностический тест 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.

Первичные конечные точки

• STAI Questionnaire [Срок оценки: 3.5 years]
• Burn Pit Exposure Questionnaire [Срок оценки: 1 day]
• Cancer Outcomes Follow up Questionnaire [Срок оценки: 1 day]
• Intensive Cancer Screening Feasibility [Срок оценки: 2 years]

Вторичные конечные точки (3)

• Nasal Swab [Срок оценки: 1 day]
• Blood Collection - Multi-cancer detection Blood Test [Срок оценки: 3 years]
• Radiomic analysis [Срок оценки: 2 years]

Критерии участия

Критерии включения

• ≥ 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Inova Schar Cancer Institute — Fairfax

Идентификаторы

NCT: NCT07485322 · INOVA-2025-302

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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