Early Cancer Detection in Firefighters With Low-Dose Chest CT: A Community-Based Approach
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Proportion of participants with detected lung cancers (Aim 1)
研究概览
简要总结
Firefighters are at increased risk for cancer due to exposure to carcinogenic substances. Current lung cancer screening guidelines are predominantly based on smoking history and do not take into account high risk occupational exposures such as firefighting. This study aims to provide chest computed tomography (CT) scans to firefighters to determine the prevalence of lung cancer, other cancers detectable on CT chest, and lung diseases associated with increased cancer risk.
详细描述
This is a single-group prospective interventional study and a community-based participatory project led by University of California, San Francisco and in close collaboration with the firefighter community in California.
PRIMARY OBJECTIVE:
I. Determine the prevalence of lung cancer, other cancers and cancer risk factors detectable on chest Computerized Tomography (CT) (Aim 1).
II. Identify imaging and non-imaging predictors of lung cancer and other cancers detectable on chest CT.
SECONDARY OBJECTIVE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 35 years or greater. If the participant is above the age of 80, participants must be otherwise healthy and well-fit to undergo treatment if lung cancer were to be discovered.
- •Never smoker or quit more than 15 years ago.
- •Able to understand study procedures and to comply with them for the entire length of the study.
- •Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it.
- •Length in profession for 10 or more years. This includes both volunteer firefighting and professional firefighting, self-attested as verifiable by professional records.
- •Additional cases for Aim 2:
- •Age 18+, may include deceased firefighters.
- •A previous or current history of confirmed thoracic malignancy (except localized skin cancer, cancer in situ, or other localized cancers)
排除标准
- •Contraindication to any study-related procedure or assessment.
- •Personal history of malignancy within 5 years (except localized skin cancer, cancer in situ, or localized cancers that are definitively treated and are unlikely to recur) or lung cancer at any time.
- •Participants will be assessed for active pregnancy per standard procedure for clinical lung cancer screening CT at University of California, San Francisco which includes asking the participants directly along with documentation of whether the negative pregnancy was self-reported or confirmed with a urine pregnancy test.
- •Prior CT chest within 1 year.
- •Symptoms highly suggestive of lung cancer, including unexplained weight loss of over 30 pounds (lbs) within the past 12 months or unexplained hemoptysis.
- •No exclusion criteria
研究组 & 干预措施
Firefighters (Lung Screening CT)
Participants will receive a single, low-dose, chest CT without contrast as indicated for lung cancer screening. Participants will be followed up for at least 1 year following the scan and have ongoing medical record reviews.
干预措施: Questionnaires (Other)
Firefighters (Lung Screening CT)
Participants will receive a single, low-dose, chest CT without contrast as indicated for lung cancer screening. Participants will be followed up for at least 1 year following the scan and have ongoing medical record reviews.
干预措施: Low-dose Computerized tomography (CT) of Chest (Procedure)
Firefighters (Lung Screening CT)
Participants will receive a single, low-dose, chest CT without contrast as indicated for lung cancer screening. Participants will be followed up for at least 1 year following the scan and have ongoing medical record reviews.
干预措施: Medical History (Other)
Firefighters with Previously Diagnosed Malignancy
Participants with a history of cancer will have a medical record review as part of a case-control cohort.
干预措施: Medical History (Other)
结局指标
主要结局
Proportion of participants with detected lung cancers (Aim 1)
时间窗: Up to 10 years
The proportion of participants with detected lung cancers will be determined by the frequency of image findings that indicate lung cancer, and an ultimate clinical diagnosis associated with the imaging finding.
Proportion of participants with detected other cancers (Aim 1)
时间窗: Up to 10 years
The proportion of participants with detected cancers, other than lung, will be determined by the frequency of image findings that indicate other cancer, and an ultimate clinical diagnosis associated with the imaging finding.
Proportion of participants with occupational lung disease (Aim 1)
时间窗: Up to 10 years
Occupational or work-related lung diseases are lung conditions that have been caused or made worse by long-term exposure to certain irritants in the workplace. The proportion of participants with occupational lung disease will be determined by the frequency of image findings that indicate occupationally associated lung disease, and an ultimate clinical diagnosis associated with the imaging finding.
Proportion of participants with diagnosed interstitial lung disease (Aim 1)
时间窗: Up to 10 years
Interstitial Lung Disease (ILD) is a group of diseases that irritate, inflame, or scar the lungs and supporting air sacs. The proportion of participants with diagnosed interstitial lung disease will be determined by the frequency of image findings that indicate ILD, and an ultimate clinical diagnosis associated with the imaging finding.
Number of participants within of each Lung-RADS risk group
时间窗: Up to 10 years
The Lung CT Screening Reporting and Data System (Lung-RADS) is a measure developed by the American College of Radiologists to standardize the reporting and management of screen-detected pulmonary nodules. Nodules are categorized as 0=Incomplete, 1=Negative, 2=Benign Appearance or Behavior, 3=Probably Benign, or 4A /4B /4X = Suspicious with an additional modifier of S=Other or C=Prior Lung Cancer to be added to the 4 category codes as needed. The frequency of participants within each Lung-RADS risk group as determined by imaging procedures will be reported.
次要结局
- Percentage of participants with incidental clinical findings(Up to 10 years)
- Number of risk factors identified as associated with cancer development(Up to 10 years)