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临床试验/NCT07057102
NCT07057102招募中不适用

Applications of Multiple Omics Sequencing Technologies in Predicting the Efficacy and Monitoring the Recurrence of Non-Small Cell Lung Cancer: A Prospective, Non-Interventional Study

Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年1月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Liquid Biopsy Biomarkers

研究概览

简要总结

Lung cancer is one of the diseases with the highest global incidence and mortality. Studies have confirmed that liquid biopsy markers such as minimal residual disease (MRD) detection in solid tumors, circulating tumor DNA (ctDNA), and T-cell receptor (TCR) have roles in monitoring disease status, prognostic evaluation, recurrence prediction, and guiding treatment decisions in NSCLC patients. Peripheral blood dynamic monitoring indicators have broad application prospects and may completely transform the treatment paradigm for NSCLC patients in the future. However, current limitations exist, including the need to improve the sensitivity of detection methods, the lack of uniform criteria for defining MRD positivity, the undetermined timing and cycle of MRD testing, and insufficient results from large-scale prospective clinical trials. Therefore, the transition of peripheral blood-based dynamic testing to routine clinical practice still requires results from large-scale prospective clinical trials. This study intends to conduct a prospective clinical trial enrolling NSCLC patients with different stages and treatment modalities (immunotherapy combined with chemotherapy, targeted therapy combined with chemotherapy, neoadjuvant therapy, adjuvant therapy). Based on peripheral blood and tumor tissue samples, it will systematically integrate multi-omics approaches including ctDNA testing, whole exome sequencing (WES), genome-wide methylation sequencing (GM-seq), and TCR-seq to carry out comprehensive, precise, and dynamic biomarker detection for efficacy monitoring and recurrence prediction, providing new methods and evidence for the clinical application of dynamic liquid biopsy monitoring in lung cancer.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Voluntarily signed the informed consent;
  • Aged 18 years or older;
  • Expected life expectancy of ≥3 months;
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (see Appendix 1);
  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) patients;
  • Classified as stage II, III, or IV according to the AJCC TNM staging system (9th edition);
  • Willing to provide blood samples and pre-treatment paraffin-embedded tissue samples;
  • With evaluable target lesions for efficacy assessment.
  • Exclusion Criteria
  • In the investigator's opinion, unsuitable for peripheral blood collection due to complications or other circumstances;
  • Active, known, or suspected autoimmune diseases (except vitiligo, type 1 diabetes, residual hypothyroidism caused by autoimmune thyroiditis requiring only hormone replacement therapy, or conditions not expected to relapse without external stimulation);
  • Active tuberculosis (TB) infection confirmed by chest X-ray, sputum examination, and clinical physical examination. Patients with a history of active TB infection within the past 1 year, even if treated, will be excluded. Patients with a history of active TB infection more than 1 year ago will also be excluded unless they can demonstrate that previous antitubercular treatment was fully effective;
  • Comorbidities requiring treatment with immunosuppressive drugs, or comorbidities requiring systemic or local corticosteroids at immunosuppressive doses;
  • Pregnant or lactating;
  • Positive for human immunodeficiency virus antibody (HIVAb), active hepatitis B virus infection (HBsAg-positive and HBV-DNA > 10³ copies/ml), or hepatitis C virus infection (HCV antibody-positive and HCV-RNA > the lower limit of detection at the study center);
  • History of severe neurological or psychiatric disorders, including but not limited to: dementia, depression, seizures, bipolar disorder, etc.;
  • Use of any antitumor-active drugs prior to blood sample collection;
  • Previous history of other malignancies (excluding non-melanoma skin cancer and the following in situ carcinomas: bladder, stomach, colon, endometrium, cervix/dysplasia, melanoma, or breast cancer);
  • Administration of live vaccines within 28 days prior to blood sample collection.

排除标准

  • 未提供

结局指标

主要结局

Liquid Biopsy Biomarkers

时间窗: From enrollment to the end of monitoring at 3 years or the occurrence of disease progression.

Liquid biopsy biomarkers for efficacy monitoring, prognostic evaluation, and recurrence prediction

次要结局

  • Comparison of MRD and Conventional Imaging(From enrollment to the end of monitoring at 3 years or the occurrence of disease progression.)
  • The appropriate timing for minimal residual disease (MRD) testing(From enrollment to the end of monitoring at 3 years or the occurrence of disease progression.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhijie Wang

Professor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

研究点 (1)

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