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A Prospective Study Investigating the Relationship Between Minimal Residual Disease Detection, Monitoring Frequency, and Prognosis in Non-small Cell Lung Cancer Patients Eligible for Curative Treatment.
Sponsor: National Cancer Center, Japan
Summary
Adding immune checkpoint inhibitors or molecularly targeted drugs as adjuvant therapy to curative treatments-such as surgery or chemoradiotherapy-for stage I-III non-small cell lung cancer (NSCLC) has been established as a standard of care and has improved treatment outcomes. However, there is currently no adequate method to determine which patients should receive these adjuvant therapies. Identifying those with a good prognosis without adjuvant therapy could reduce the risk of adverse events, lessen the burden of clinic visits, and reduce healthcare costs. Among various approaches, ctDNA-based MRD (minimal residual disease) analysis is highly anticipated and has already been introduced into clinical practice for hematologic malignancies. However, solid tumors' development as a companion diagnostic has been limited, and regulatory approval is mainly being considered based on performance evaluation data. In this study, we will conduct a performance evaluation of MRD analysis using Signatera™ in patients with stage I-III NSCLC while also collecting other prognostic factors based on clinicopathological information and survival data.
Official title: Prospective Observational Study Using Personalized Minimal Residual Disease Assay (Signatera) to Evaluate the Kinetics and Detection Rate in Patients with Non-small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
350
Start Date
2025-03-01
Completion Date
2029-09-30
Last Updated
2025-03-03
Healthy Volunteers
No
Conditions
Locations (1)
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan