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NCT06854939: MRDSEEKER

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.

Not yet recruiting Last updated 3 March 2025
What this trial tests

trial in NSCLC, Stage I, II, III in 350 participants. Not yet recruiting.

Timeline
1 March 2025
Primary endpoint
30 September 2026
30 September 2029

Quick facts

Lead sponsorNational Cancer Center, Japan
StatusNot yet recruiting
Study typeOBSERVATIONAL
Enrollment350
Start date1 March 2025
Primary completion30 September 2026
Estimated completion30 September 2029
Sites1 location across Japan

Conditions studied

Sponsor

National Cancer Center, Japan

Who can join

18 and older, any sex, with NSCLC, Stage I, II, III. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. [MRD Testing in Lung Cancer-Latest Insights and Developments].
    Karasaki T, Horinouchi H. · · 2025 · cited 1× · PMID 40563149

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Other National Cancer Center, Japan trials

Trials by the same sponsor.

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