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

NCT06181929 | Recruiting

• 1 other identifier: 20223-10-101
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Risk Behaviors

Outcome Measures

Primary Outcomes (1)

• Lung cancer detection rate

  detection rate

  up to 2years

Secondary Outcomes (3)

• incidence of lung cancer

  up to 2years

• distribution of lung cancer stages

  up to 2years

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

  up to 2years

Other Outcomes (1)

• identification of potential predictive biomarkers of malignancy

  up to 2years

Study Arms (1)

intervation group

EXPERIMENTAL

LDCT screening exam

Diagnostic Test: Low dose CT

Interventions

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

intervation group

Eligibility Criteria

• Age: 45 Years - 74 Years
• Gender Eligibility Details: Korean female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• Medical or psychiatric condition precluding informed medical consent.
• History of LDCT screening, chest CT, PET or PET/CT scan within 10 years

Sponsors & Collaborators

• Sang-Won Um: lead

Study Sites (1)

Samsung Medical Center

Seoul, Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Health Risk Behaviors

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Um Sang-Won, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Um Sang-Won, PhD

CONTACT

82-2-3410-1645; sangwonum72@gmail.com

Kyungmi Park

CONTACT

82-2-2008-0429; gyeong.mi@sbri.co.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Model Details: single-arm prospective pilot study

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: December 26, 2023
• Study Start: June 1, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2034
• Last Updated: March 5, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)