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

NCT ID: NCT06181929

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2034-05-31

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.

Conditions

Health Risk Behaviors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

intervation group

LDCT screening exam

Group Type: EXPERIMENTAL

Low dose CT

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Low dose CT

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sang-Won Um

OTHER

Sponsor Role: lead

Responsible Party

Sang-Won Um

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Um Sang-Won, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, Seoul, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Um Sang-Won, PhD

Role: CONTACT

sangwonum72@gmail.com

82-2-3410-1645

Kyungmi Park

Role: CONTACT

gyeong.mi@sbri.co.kr

82-2-2008-0429

Facility Contacts

Sang-Won Um, MD, PhD

Role: primary

sangwonum72@gmail.com

+82-2-3410-1645

Other Identifiers

20223-10-101

Identifier Type: -

Identifier Source: org_study_id