NCT05164757进行中（未招募）不适用
Female Asian Nonsmoker Screening Study (FANSS)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,041
- 试验地点
- 1
- 主要终点
- Number of participants who inquire about the program and are eligible to proceed with the Low Dose Computed Tomography (LDCT) screening test
研究概览
简要总结
The study team propose to develop a database and biorepository of Asian female never smokers. This population is at increased risk for developing lung cancer but do not meet current lung cancer screening criteria. Study procedures will include up to 3 low-dose CT (LDCT) scans and a blood-based assay with the capability for early detection of cancer. Clinical, demographic and exposure history including possible WTC exposure will also be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 40-74 years
- •Never Smoker defined as a lifetime exposure of less than 100 cigarettes
- •Identify as from Asian descent, defined as having reported ancestry or race from the continent of Asia. Individuals with mixed heritage are eligible.
排除标准
- •Prior history of lung cancer.
- •Treatment for, or advisement by a physician of evidence of any cancer within the past five years, with the exceptions of non-melanoma skin cancer and most in-situ carcinomas based on PI discretion. (Treatment for, or evidence of, melanoma or in-situ bladder/transition cell carcinomas within the preceding five years renders the potential participant ineligible.)
- •Participation in a cancer prevention trial.
- •Present symptoms suggestive of current lung cancer, including: unexplained weight loss of over 15 pounds within the 12 months or unexplained hemoptysis.
- •Medical or psychiatric condition precluding informed medical consent.
- •Pneumonia or acute respiratory infection within 12 weeks of enrollment that was treated with antibiotics under physician supervision.
结局指标
主要结局
Number of participants who inquire about the program and are eligible to proceed with the Low Dose Computed Tomography (LDCT) screening test
时间窗: Screening (Day -28 to -1)
Number of Participants who undergo initial LDCT
时间窗: Visit 2 (Day 30 +/- 7)
次要结局
- Detection rate of Incidental coronary artery disease(Visit 6 (day 730 +/- 14))
- Number of diagnoses of lung cancer(Visit 6 (day 730 +/- 14))
- Detection rate of Incidental thyroid nodules(Visit 6 (day 730 +/- 14))
- Detection rate of Incidental thyroid nodules(Visit 2 (Day 30 +/- 7))
- Detection rate of Incidental thyroid nodules(Visit 4 (Day 365 +/- 14))
- Detection rate of Incidental coronary artery disease(Visit 2 (Day 30 +/- 7))
- Detection rate of Incidental coronary artery disease(Visit 4 (Day 365 +/- 14))
- Number of diagnoses of lung cancer(Visit 2 (Day 30 +/- 7))
- Number of diagnoses of lung cancer(Visit 4 (Day 365 +/- 14))
研究者
研究点 (1)
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