What is this study trying to find out about lung cancer in Korean females?

This study is evaluating early detection of lung cancer in Korean females who have never smoked but have a family history of lung cancer. Researchers aim to understand how effective low dose CT scans and blood tests are in identifying lung cancer early. The sponsor is Sang-Won Um, focusing on improving diagnosis for this specific group.

Who may be eligible for this lung cancer clinical trial?

Adults aged 45 to 74 years who are Korean females and have never smoked (less than 100 cigarettes in lifetime) may be eligible. They also need a family history of lung cancer in a first-degree relative. Certain medical conditions and prior cancer history may exclude participation. Please review eligibility criteria for more details.

Is there any cost to participate in this lung cancer clinical trial?

Study-related care, including the low dose CT scans and all trial visits, is provided at no cost. Personal travel expenses and other costs may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation expenses.

Actively Recruiting

Phase Not Applicable

Age: 45Years - 74Years

FEMALE

Healthy Volunteers

ID06181929

Study to Detect Lung Cancer Early in Korean Women Aged 45 to 74 Who Have Never Smoked and Have a Family History of Lung Cancer

Led by Sang-Won Um · Updated on 2025-03-05

200

Participants Needed

Research Sites

417 weeks

Total Duration

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

Age: 45Years - 74Years

FEMALE

Healthy Volunteers

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

Research Team

Um Sang-Won, PhD

Kyungmi Park

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