Changes of Tumor-related Biomarkers Before and After Pulmonary Nodule Biopsy and Their Clinical Implications.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Reasons of study termination
研究概览
简要总结
In the past few years, circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), microRNAs, autoantibodies, and T-cell receptor repertoire are new biomarkers of liquid biopsy in cancer, which has been demonstrated to have a great value in diagnostics, treatment evaluation, and prognosis prediction. However, most of previous data were based on late stage tumor patients. This study plans to utilize the minimally invasive method to detect the changes of numbers of CTCs, ctDNA hot spot mutations and methylation signals, microRNAs, autoantibodies, and T-cell receptor repertoire in early stage lung cancer patients before and after pulmonary nodule biopsy, during therapeutic and follow-up periods, in order to evaluate the clinical values of above tumor-related biomarkers.
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
- •Confirmed as suspected lung cancer patients with pulmonary nodules (single or multiple) by CT scans, and the maximum diameter of nodule is between 8mm and 3cm;
- •Male or female, with age of 18~80 years;
- •Agree to take the pulmonary nodule biopsy, and sign the Informed Consent.
排除标准
- •With severe comorbidities and unable to participate in this study;
- •Diagnosed with acute respiratory tract infection, for instance fungus, mycobacterium tuberculosis or other bacteria, virus, etc., one month prior to the study recruitment;
- •Pregnant or maternal women;
- •Diagnosed with other carcinoma, and the pulmonary nodules suspected of stemming from other sites;
- •Unable for regular follow-ups according to the research protocol;
- •Blood sample is not qualified for biomarker testing.
结局指标
主要结局
Reasons of study termination
时间窗: Baseline and every three- or six-month follow-up within two years for each patient.
Complete the study, Lost to follow-up, Withdrawal of informed consent, Terminated by the investigator, Severe adverse event(SAE).
Death or survival
时间窗: Baseline and every three- or six-month follow-up within two years for each patient.
Death or survival
Disease progress
时间窗: Baseline and every three- or six-month follow-up within two years for each patient.
Complete Response(CR), Partial Response(PR), Stable Disease(SD), Progressive Disease(PD)
次要结局
未报告次要终点
研究者
Chen Wang
Professor
China-Japan Friendship Hospital