The LEAP Study: A Multicenter Biospecimen and Imaging Resource for Lung Cancer Screening

Area of Science:

• Oncology
• Radiology
• Biomarker Discovery

Background:

• Blood-based biomarkers can enhance lung cancer screening (LCS) effectiveness by improving risk stratification and nodule assessment.
• The Lung Cancer, Early Detection, Assessment of Risk, and Prevention (LEAP) study was designed to create a reference set for validating cancer biomarkers in LCS.

Purpose of the Study:

• To establish a prospective international cohort for validating blood-based biomarkers in lung cancer screening.
• To collect longitudinal data including low-dose CT (LDCT) imaging and blood specimens from high-risk individuals.

Main Methods:

• Prospective international cohort study enrolling individuals at high risk for lung cancer.
• Three annual rounds of low-dose CT (LDCT) screening with blood specimen collection.
• Data collection via questionnaires and medical chart reviews to determine cancer status.

Main Results:

• 2,841 participants enrolled; LDCT scans performed at baseline, year 1, and year 2.
• Detected lung cancer in 0.9% at baseline and year 1, and 0.7% at year 2.
• Collected 6,586 blood specimens, including prediagnostic samples within 5 years of diagnosis.

Conclusions:

• The LEAP cohort provides a valuable resource for biomarker validation in lung cancer screening.
• Longitudinal data, LDCT imaging, and matched blood specimens address clinical needs in LCS.
• The study supports the development of improved lung cancer diagnostic tools.