Lung Cancer Detection and Staging by Extracellular Monitoring of Metabolic Activity Profiles of Peripheral Blood Mononuclear Cells (PBMC)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 950
- 试验地点
- 2
- 主要终点
- Positive and negative diagnosis (scored 0/1 dichotomously) of lung cancer
研究概览
简要总结
Purpose: To evaluate the performance of Extracellular Monitoring of Metabolic Activity Profiles of Peripheral Blood Mononuclear Cells (PBMC) analysis method in identifying lung cancer.
The study population will include a total of 950 participants, patients with lung cancer before any treatment, and healthy and COPD patients as a control group.
详细描述
The purpose of the study is to evaluate the performance of Extracellular Monitoring of Metabolic Activity Profiles of Peripheral Blood Mononuclear Cells (PBMC) analysis method in identifying lung cancer.
The analysis method described in this protocol is a novel simple plausible immunological approach which is non-invasive, high throughput, real-time quantitative monitoring of metabolic activity (MA) profiles of fresh Peripheral Blood Mononuclear Cells (PBMC) in response to various reagents at different concentrations.
Study Design Prospective, three groups, open, comparative, controlled study. No. of Sites One Study Population Man and Women aged 18 - 90 years old. No. of Subjects A total of 950 completed, evaluated subjects will be enrolled in this study.
The groups sample size is as follows:
Group 1 - 75 subjects Group 2 - 75 subjects Group 3 - 150 subjects Group 4 - 650 subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject signed the informed consent.
- •Subject is between 18 to 90 years old.
- •Lung cancer diagnosis before any treatment
排除标准
- •Lung cancer patients
- •Subject has been previously treated for any type of malignant or benign tumor (for example: colon or uterus polyps removal).
- •Subject has active infection or inflammation determined clinically at screening.
- •Subject is currently treated with concomitant medication related directly or can affect the immune system.
- •Subject lactating or undergoing fertility treatment.
- •Subject has impaired judgment.
- •Known positive HIV, hepatitis B, or hepatitis C, autoimmune disease.
- •Known history of a significant medical disorder, which in the investigators' judgment contraindicates the patient's participation.
- •Known hypersensitivity and/or allergy
- •Drug or alcohol abuse (by history).
- •Subject is participating in any other clinical trial, drug or device study within 30 days prior sample collection
- •Relatives of the study investigators or employees of the study investigators are not allowed to participate in the study
研究组 & 干预措施
lung cancer diagnosis
4 arms will be included in the study:
The groups sample size is as follows:
Group 1 - Healthy non smoker- 75 subjects Group 2 - Healthy smoker- 75 subjects Group 3 - Patients diagnosed as having COPD- 150 subjects Group 4 - Patients with diagnosis of lung cancer- 650 subjects
A blood test will be taken from each patient.
干预措施: Blood test (Other)
结局指标
主要结局
Positive and negative diagnosis (scored 0/1 dichotomously) of lung cancer
时间窗: 1 year
次要结局
未报告次要终点