Tracking Genomic Cancer Evolution in Patients for Stage IB,II and IIIA Non-small Cell Lung Cancer After Radical Resection: The Tracking Molecular Evolution for NSCLC (T-MENC) Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 10
- 主要终点
- Tumor genomic clonal evolution assessed with liquid biopsy of stage IB,II and IIIA non-small cell lung cancer patients after getting radical resection.
研究概览
简要总结
Tumor genomic clonal evolution assessed with liquid biopsy of stage IB,II and IIIA non-small cell lung cancer patients after getting radical resection. Plasma circulating tumor DNA (ctDNA) analysis detects molecule residual disease and predicts recurrence in patients. The concordance of the relative abundance of mutations in plasma ctDNA with cancer recurrence.
详细描述
In the study, 200 of stage IB,II and IIIA non-small cell lung cancer patients obtained radical resection will be recruited. All the patients will receive biopsy genotype assay and ctDNA liquid biopsy. The abundance of mutations of ctDNA was tracked at 4 time points, including:
- st: 10 Days after patients received radical resection.
- nd: When patients finished the chemotherapy or target drug delivery two cycles.
- rd: 10 Days after patients finished the chemotherapy or target drug delivery four cycles.
- th: When tumor recrudescence / 2 years after radical resection.
Tumor genomic clonal evolution was assessed by analyzing the relative abundance of mutations in plasma circulating tumor DNA (ctDNA).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent and assigned.
- •Newly diagnosed and histological or cytological confirmed stage IB-IIIA lung adenocarcinoma or non-smoking squamous cell carcinoma patients according to the AJCC staging system.
- •Expected radical resection.
- •Patients expected more than 3 months of survival time.
- •Willingness to comply with required protocols and give permission to use the data for clinical research and products development.
排除标准
- •Patients who want Neo-adjuvant therapy.
- •Patients with T3-4N1 Pancoast tumors (superior sulcal tumors).
- •Multi-station N2 non-small cell lung cancer with lymph node metastasis.
- •Eastern cooperative oncology group (ECOG) performance status > 2 after postoperative chemotherapy
- •Eastern cooperative oncology group (ECOG) performance status > 4 after postoperative targeted therapy.
- •Patients must never ever has received for any history of radiotherapy/ chemotherapy/surgery before.
- •Patients have other primary cancers.
- •Known central nervous system metastasis.
- •Patients expected less than 3 months of survival time.
- •Other situations mismatch this program.
结局指标
主要结局
Tumor genomic clonal evolution assessed with liquid biopsy of stage IB,II and IIIA non-small cell lung cancer patients after getting radical resection.
时间窗: From assignment of the first subject to the time point when tumor recrudescence or 2 years after radical resection. The last participant will be recruited before June 30,2021.
The tumor molecular clones and the frequency of gene mutations from 1021 tumor related genes will be detected by next-generation sequencing, which will be matched with the CT scanning.
The concordance of the plasma ctDNA detection status with Progress Free Survival (PFS) and Overall Survival (OS) after radical resection or/and under adjuvant therapy.
时间窗: From assignment of the first subject to the time point when tumor recrudescence or 2 years after radical resection. The last participant will be recruited before June 30, 2021.
Plasma circulating tumor DNA (ctDNA) analysis detects molecule residual disease and predicts recurrence in patients. All the patients will receive biopsy genotype assay and ctDNA liquid biopsy.
次要结局
- The molecular mechanism between the tumor recurrence and ctDNA mutations(From assignment of the first subject to the time point when tumor recrudescence or 2 years after radical resection. The last participant will be recruited before June 30, 2021.)
- Evaluation of ctDNA detecting assay in monitoring recurrence of early stage of lung cancer after radical resection.(From assignment of the first subject to the time point when tumor recrudescence or 2 years after radical resection. The last participant will be recruited before June 30, 2021.)