Clinical trial NCT06181929: A Prospective Study for the Early Diagnosis of Lung Cancer in Korean Females
Official title: A Prospective Study for the Early Diagnosis of Lung Cancer in Korean Females Who Are Never Smoker with a Family History of Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health Risk Behaviors
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 200
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single-arm prospective pilot study
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Lung cancer detection rate
timeFrame: up to 2years
Secondary outcomes:
measure: incidence of lung cancer
timeFrame: up to 2years
measure: distribution of lung cancer stages
timeFrame: up to 2years
measure: Estimation of the Early Detection Rate of Lung Cancer in Liquid Biopsy
timeFrame: up to 2years
Other outcomes:
measure: identification of potential predictive biomarkers of malignancy
timeFrame: up to 2years
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Um Sang-Won, PhD
role: PRINCIPAL_INVESTIGATOR
References: