Serum Thioredoxin Reductase Activity Research in First-line Chemotherapy Advanced Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- To measure the thioredoxin reductase activity in blood
研究概览
简要总结
In pre-clinical study we found that the thioredoxin reductase activity of serum harbours huge difference between cancer patients and non-cancer patients, the enzyme activity elevated remarkably among cancer patients, and after any kind of treatment serum thioredoxin reductase activity declined remarkably, so we hypothesis that serum thioredoxin reductase activity could be a warning marker for early progression of first-line treatment for advanced non-small cell lung cancer
详细描述
This is a cooperative research project involving patients in Medical Oncology Department of Affiliated Cancer Hospital of Xiangya School of Medicine Central South University, and the State Key Laboratory for Natural Medicine and Biomimetic Drugs Perking University. The primary objective is to measure the thioredoxin reductase activity using blood in subjects received platinum based chemotherapy, to study the warning progression ability of thioredoxin reductase in blood. The secondary objective is to compare the warning progression activity of blood thioredoxin reductase reductase activity with carcinoembryonic antigen in subjects received platinum based first-line chemotherapy. Blood will be collected before chemotherapy, after every 2 cycles of chemotherapy, every 3 months after all first-line chemotherapy till 2 years, then every 6 months till 3 years, or collect blood till tumor progression, evaluation CT results every time collecting blood samples.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Pathologically proven non-small cell lung cancer, stage Ⅳ patients or unsuitable for local treatment of ⅢB stage patients
- •Malignant tumor treatment naive including surgery（except for surgery for cervical cancer and cutaneous squamous cell carcinoma 5 years before, except for lung cancer patients who received surgery and adjuvant chemotherapy after 12 month then diagnosed with stage ⅢB or Ⅳ）
- •Signed informed consent would like to provide blood for research
排除标准
- •Patients received antitumor treatment before
- •Patients with contraindication of chemotherapy
- •Pregnant or breast feeding women
结局指标
主要结局
To measure the thioredoxin reductase activity in blood
时间窗: may 2013 - may 2014 (1 year)
3-4 ml whole blood was obtained and then centrifuged and stored at -20 ℃, thioredoxin reductase activity was measured within 30 days using 5，5'-Dithio bis-（2-nitrobenzoic acid）(DTNB) method.
次要结局
- To measure the carcinoembryonic antigen (CEA) level in blood(may 2013- may 2014 (1 year))
研究者
Yongchang Zhang
chief
Hunan Province Tumor Hospital