Low Dose CT Screening Study for Korean Female Nonsmoker With Family History of Lung Cancer

Study Overview
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Brief Summary
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This is a single-arm prospective pilot study in a single institution. The target accrual is 200 participants of Korean, female sex, never smoker status, and family history of lung cancer. The study will aim to enroll 200 participants in two years.

Detailed Description
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Interested individuals will contact a research coordinator who will help to assess for study eligibility. Individuals who are eligible and able to sign informed consent will then proceed to have a LDCT screening exam with a result reported by a radiologist approved to read lung cancer screening scans. Results of this screening test will be discussed with the subject and further recommendations will be given. Negative results will proceed to have repeat LDCT exams for two additional years. Positive results will be recommended to have further diagnostic work-up, and possible treatment. Those with positive findings may be recommended to repeat a LDCT at varied intervals (e.g. at 3 months, at 6 months, etc.) per Lung-RADS recommendations which can be conducted as a research LDCT or as standard-of-care. In addition, blood draw collection for a plasma-based assay will be collected at baseline, first year and second year for all patients along with the repeated LDCT scans. A medical history questionnaire containing questions regarding ethnicity, family history of lung cancer, environmental exposures including secondhand smoke exposure, and a residential district to estimate the exposure of PM2.5 or PM10 will be given to the patient at the initial visit after informed consent has been obtained (Appendix A). Questionnaire can be collected within 1 month from the baseline consent.

Official Title
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Low Dose CT Screening Study for Korean Female Nonsmoker With Family History of Lung Cancer

Conditions
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Health Risk Behaviors

Intervention / Treatment
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* Diagnostic Test: Low dose CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 45-74 years old Korean female Never smoker defined as a lifetime exposure of less than 100 cigarettes Family history of lung cancer at first degree relatives (parents, siblings, or children) Exclusion Criteria: Prior history of lung cancer. Diagnosis of any cancer within the past five years Participation in a cancer prevention trial. Present symptoms suggestive of current lung cancer, including: unexplained weight loss of over 5 kilograms within the last 12 months or unexplained hemoptysis. Medical or psychiatric condition precluding informed medical consent. History of LDCT screening, chest CT, PET or PET/CT scan within 10 years

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: single-arm prospective pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervation group<br>LDCT screening exam | Diagnostic Test: Low dose CT<br>* A subject can voluntarily discontinue active screening with LDCTs after the baseline LDCT is completed but will remain in study follow-up with follow-up calls in 12-month intervals for up to 10 years since initial consent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Low Dose CT Lung Cancer Screening Program | participation rate | up to 2years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence and incidence of lung cancer | Whether lung cancer is found in each screening test conducted for the first (baseline) and first and second years | up to 2years | 
| distribution of lung cancer stages | number of lung cancer diagnosed, number of stage I, rate of surgery, rate of false positive | up to 2years | 
| Estimation of the Early Detection Rate of Lung Cancer in Liquid Biopsy | cfDNA | up to 2years |