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Идёт набор NCT06930807

Liquid Biopsy-Based Novel Modality for Postoperative Management of Lung Cancer

Без фазы С лечением Non-small Cell Lung Cancer Minimal Residual Disease Adaptive Treatment

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Adaptive postoperative management based on minimal residual disease.
Кому может быть актуально
Состояния в реестре: Non-small Cell Lung Cancer, Minimal Residual Disease, Adaptive Treatment. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Development and Validation of Non-Invasive Monitoring Techniques for Postoperative Recurrence and Novel Adjuvant Therapeutic Strategies in Lung Cancer

Обзор

The goal of this study is to develop new techniques for minimal residual disease(MRD) monitoring and to confirm the efficacy and safety of MRD-guided postoperative management for early stage non-small cell lung cancer. The main questions this study aims to answer are: * How to develop multi-omics-based high-sensitivity detection methods to accurately capture MRD and monitor postoperative recurrence in lung cancer? * Is adaptive treatment guided by ctDNA-MRD for lung cancer patients superior to traditional clinical management and effectively improves survival? * Do heterogeneous patient populations (grouped by stages, histopathological subtypes, driver mutations, and treatment histories) show differences in effects under ctDNA-MRD guided postoperative management strategies?

Подробное описание

Approximately 30% of early-stage lung cancer patients experience recurrence after curative surgery. However, the clinical utility of routine chest CT surveillance remains limited. Emerging evidence has demonstrated that liquid biopsy-based minimal residual disease (MRD) detection may serve as a more sensitive monitoring strategy. Longitudinal ctDNA dynamics analysis further enables real-time assessment of tumor progression and early detection of molecular relapse.

This study aims to develop a novel multidimensional approach for non-invasive postoperative recurrence monitoring in lung cancer and establish an MRD-guided adjuvant therapy model to optimize precision treatment and MRD-stratified follow-up protocols for lung cancer patients. This study will evaluate the sensitivity and specificity of novel monitoring methods and further compare emerging non-invasive recurrence monitoring approaches with conventional ctDNA-based techniques, driving continuous advancements in lung cancer research.

Вмешательства

  • Другое Adaptive postoperative management based on minimal residual disease
    participants will not receive postoperative treatment if (neoadjuvant therapy efficacy reaches pCR and) MRD results keep negative.

Первичные конечные точки

  • Two-year recurrence-free survival rate [Срок оценки: Time from curative surgery to confirmation of clinical progression (recurrence or metastasis) within two years.]
Вторичные конечные точки (4)
  • Overall survival [Срок оценки: Time from curative surgery to confirmation of death (any cause)，assessed up to 60 months.]
  • Incremental cost effectiveness ratio [Срок оценки: 24 months after surgery]
  • Timely diagnosis rate by the novel MRD monitoring technique [Срок оценки: two years]
  • Sensitivity of the novel MRD monitoring approach [Срок оценки: two years]

Критерии участия

Критерии включения

  • Non-small cell lung cancer with stage IA-IIIA (8th edition TNM classification) planning to undergo curative surgery or to undergo neoadjuvant therapy
  • Solid nodules >1 cm or ground-glass nodules >1.5 cm on imaging
  • No history of malignancies other than non-small cell lung cancer in the past 5 years
  • Specimens are well preserved and imaging documents are accessible.

Критерии исключения

  • Age<18 years old
  • Non-small cell lung cancer with pathologic stage IIIB-IV (8th edition TNM classification)
  • Pathology results confirmed not to be non-small cell lung cancer
  • History of malignancies other than non-small cell lung cancer in the past 5 years

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Peking University People's Hospital — Пекин

Идентификаторы

NCT: NCT06930807 · 2023ZD0501900

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗