治癒的治療の対象となる非小細胞肺がん患者における微小残存病変の検出、モニタリング頻度、および予後との関係を調査する前向き研究。

基本情報

NCT ID

NCT06854939

ステータス

募集前

試験のフェーズ

-

試験タイプ

観察

目標被験者数

350

治験依頼者名

National Cancer Center, Japan

概要

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.

対象疾患

依頼者（Sponsor）

実施施設 (1)