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

A Prospective Study for the Early Diagnosis of Lung Cancer in Korean Females Who Are Never Smoker With a Family History of Lung Cancer

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Health Risk Behaviors
• Intervention / Treatment: Diagnostic test: Low dose CT

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Um Sang-Won, PhD; Phone Number: 82-2-3410-1645; Email: sangwonum72@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervation group; LDCT screening exam	Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung cancer detection rate	detection rate	up to 2years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
identification of potential predictive biomarkers of malignancy	EGFR mutation	up to 2years

Collaborators and Investigators

• Sponsor: Sang-Won Um
• Investigators: Principal Investigator: Um Sang-Won, PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2034

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Actual): December 26, 2023

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 20223-10-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No