Actively Recruiting
A Prospective Study for the Early Diagnosis of Lung Cancer in Korean Females Who Are Never Smoker with a Family History of Lung Cancer
Led by Sang-Won Um · Updated on 2025-03-05
200
Participants Needed
1
Research Sites
417 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a single-arm prospective pilot study to evaluate early diagnosis of lung cancer in Korean females who have never smoked and have a family history of lung cancer. The study aims to enroll 200 participants over two years at a single institution. It focuses on assessing lung cancer detection rates and related outcomes over a two-year period. Participants will undergo an initial low dose CT (LDCT) screening exam, with results reviewed by a qualified radiologist. Those with negative results will have repeat LDCT exams annually for two additional years. Participants with positive findings may receive further diagnostic work-ups or treatments and may have additional LDCT scans at intervals per Lung-RADS recommendations. Blood samples for a plasma-based assay will be collected at baseline, one year, and two years alongside the imaging. During the study, participants will complete a medical history questionnaire covering ethnicity, family history, environmental exposures, and residential district to estimate pollution exposure. Follow-up includes discussions of scan results and recommendations, with monitoring for lung cancer detection rates and stages. Participants may voluntarily stop active LDCT screening after baseline but can continue follow-up calls for up to 10 years. The total study duration involves repeated annual assessments and long-term observation.
CONDITIONS
Brief Title
A Prospective Study for the Early Diagnosis of Lung Cancer in Korean Females
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
You will not qualify if you...
- 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 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 years
Participants undergo low dose CT (LDCT) screening exams to detect early signs of lung cancer.
3 LDCT screening visits over 2 years
Duration - Up to 10 years
Participants with negative initial LDCT results have repeat LDCT scans annually for two additional years and blood draws for plasma-based assays at baseline, year 1, and year 2. Those with positive findings may have additional diagnostic work-ups and follow-up LDCTs at varied intervals.
Annual follow-up calls for up to 10 years; blood draws at baseline, 1 year, and 2 years
Trial Site Locations
Total: 1 location
1
Samsung Medical Center
Seoul, Seoul, South Korea, 06351
Actively Recruiting
Research Team
U
Um Sang-Won, PhD
K
Kyungmi Park
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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