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

ConditionHealth Risk Behaviors

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age45-74

SponsorSang-Won Um

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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 of over 5 kilograms within the last 12 months or unexplained hemoptysis.

Trial design

Design model

Single group

Treatments tested in this trial

Low dose CT
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

Treatment groups

200 Participants

are divided into 1 treatment group

Group A: intervation groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Lung cancer detection rate

detection rate

Time frame

up to 2years

Secondary outcomes

incidence of lung cancer

Whether lung cancer is found in each screening test conducted for the first (baseline) and first and second years

Time frame

up to 2years

distribution of lung cancer stages

number of lung cancer diagnosed, number of stage I, rate of surgery, rate of false positive

Time frame

up to 2years

Estimation of the Early Detection Rate of Lung Cancer in Liquid Biopsy

cfDNA

Time frame

up to 2years

Other outcomes

identification of potential predictive biomarkers of malignancy

EGFR mutation

Time frame

up to 2years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sang-Won Um

Lead sponsor

Samsung Medical Center

Sponsor institution

Source ClinicalTrials.gov

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