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Идёт набор NCT07291921

To Conduct Multi-omics Integrated Studies in Peripheral Blood, Such as Fragment Omics, Metabolomics and Epigenetics, and Establish Non-invasive Dynamic Follow-up Monitoring Programs During Perioperative and Postoperative Periods (Observational Study)

— Наблюдательное Lung Neoplasms Neoadjuvant Therapy Immunotherapy Minimal Residual Disease

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Lung Neoplasms, Neoadjuvant Therapy, Immunotherapy, Minimal Residual Disease. Базовые параметры: 18 лет — 85 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
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Обзор

This project aims to innovatively integrate multi-omics data, including plasma metabolomics, radiomics, and cfDNA multi-level information, combined with survival data (e.g., RFS), to establish a novel multidimensional approach for noninvasive postoperative recurrence monitoring in lung cancer using artificial intelligence algorithms. The goal is to develop a new noninvasive recurrence monitoring system for lung cancer.

Подробное описание

This project is a prospective observational study designed to comprehensively integrate plasma metabolomic, radiomic, and epigenomic data to develop a predictive model for postoperative recurrence risk in lung cancer. The study will retrospectively enroll 200 patients who underwent radical surgery after neoadjuvant therapy, and prospectively enroll 100 additional post-radical-surgery lung cancer patients who received neoadjuvant treatment as a validation cohort. Peripheral blood samples will be collected at multiple timepoints for metabolomic profiling. Unsupervised clustering, random forest algorithms, and Wilcoxon tests will be applied to identify recurrence-related features and construct a recurrence prediction model.Additionally, using preoperative and first postoperative follow-up CT imaging data, a deep learning-based 3D ResNet will be employed to generate radiomic recurrence risk scores for each patient. Plasma cfDNA will undergo low-pass whole-genome sequencing and methylation analysis to extract multi-dimensional recurrence-associated features. Finally, the study will innovatively utilize the DeepProg deep learning framework to integrate radiomic, cfDNA, and plasma metabolomic data into a non-invasive multi-omics model. Combined with survival data, this model will predict recurrence risk, ultimately achieving high-accuracy stratification of patients' postoperative recurrence probability.

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 (2)
  • Overall survival [Срок оценки: Time from curative surgery to confirmation of death (any cause)，assessed up to 60 months.]
  • Timely diagnosis rate by the novel MRD monitoring technique [Срок оценки: two years]

Критерии участия

Критерии включения

  • Signed written informed consent.
  • Male or female, aged ≥ 18 and < 85 years.
  • Radical resection performed, pathologic stage IB-IIIA (8th TNM) non-small-cell lung cancer.
  • Tumor tissue and blood samples obtainable at all protocol-specified time-points.
  • No pure ground-glass nodule on imaging.
  • Completed standard neoadjuvant immunotherapy combined with platinum-based chemotherapy.

Критерии исключения

  • Postoperative pathology shows other than NSCLC, including but not limited to benign lesions, small-cell carcinoma, metastasis, or indeterminate/inadequate histology.
  • Insufficient or poor-quality blood or tissue samples.
  • Pure ground-glass nodule on imaging.
  • History of any malignancy within the past 5 years.
  • Contraindication to surgery preventing radical resection.
  • Non-radical (R2) resection.
  • Pathologic stage IIIB-N3, IIIC, or IV on paraffin sections.
  • Refusal or withdrawal of informed consent.
  • Any condition deemed unsuitable by the investigator (e.g., perioperative blood transfusion, severe psychiatric disorder precluding follow-up).

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

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

Идентификаторы

NCT: NCT07291921 · BRWEP2024W034080204-1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗