A Prospective Study for the Early Diagnosis of Lung Cancer in Korean Females

Not Applicable

Recruiting

• Conditions: Health Risk Behaviors
• Interventions: Diagnostic Test: Low dose CT

• Registration Number: NCT06181929
• Lead Sponsor: Sang-Won Um

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-11-09
• Study First Submitted QC: 2023-12-13
• Study First Posted: 2023-12-26
• Status Verified: 2024-03
• Study Start: 2024-06-01
• Last Update Submitted: 2025-03-02
• Last Update Posted: 2025-03-05
• Primary Completion: 2026-05-31
• Study Completion: 2034-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

1. Age 45-74 years old
2. Korean female
3. Never smoker defined as a lifetime exposure of less than 100 cigarettes
4. Family history of lung cancer at first degree relatives (parents, siblings, or children)

Exclusion Criteria

1. Prior history of lung cancer.
2. Diagnosis of any cancer within the past five years
3. Participation in a cancer prevention trial.
4. Present symptoms suggestive of current lung cancer, including: unexplained weight loss of over 5 kilograms within the last 12 months or unexplained hemoptysis.
5. Medical or psychiatric condition precluding informed medical consent.
6. History of LDCT screening, chest CT, PET or PET/CT scan within 10 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intervation group	Low dose CT	LDCT screening exam

Primary Outcome Measures

Name	Time	Method
Lung cancer detection rate	up to 2years	detection rate

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of