Female Asian Nonsmoker Screening Study

Study Overview
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Brief Summary
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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.

Official Title
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Female Asian Nonsmoker Screening Study (FANSS)

Conditions
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Lung Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 40-74 years Female 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who inquire about the program and are eligible to proceed with the Low Dose Computed Tomography (LDCT) screening test |  | Screening (Day -28 to -1) | 
| Number of Participants who undergo initial LDCT |  | Visit 2 (Day 30 +/- 7) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of diagnoses of lung cancer |  | Visit 2 (Day 30 +/- 7) | 
| Number of diagnoses of lung cancer |  | Visit 4 (Day 365 +/- 14) | 
| Number of diagnoses of lung cancer |  | 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 thyroid nodules |  | Visit 6 (day 730 +/- 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) | 
| Detection rate of Incidental coronary artery disease |  | Visit 6 (day 730 +/- 14) |