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

Jennifer B Dennison¹, Sebastien Gendarme^1,2, Nicole M Kettner¹

¹Department of Clinical Cancer Prevention, The University of Texas MD Anderson Cancer Center, Houston, Texas.

Cancer Epidemiology, Biomarkers & Prevention : a Publication of the American Association for Cancer Research, Cosponsored by the American Society of Preventive Oncology

|November 5, 2025

Summary

The Lung Cancer, Early Detection, Assessment of Risk, and Prevention (LEAP) study collected biospecimens and imaging data to validate blood biomarkers for lung cancer screening. This resource aids in improving lung cancer risk assessment and nodule evaluation.

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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.