Gastric Cancer Marker Detection and Its Kit Development
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 530
- 试验地点
- 1
- 主要终点
- Getting serum
研究概览
简要总结
The gastric cancer diagnosis and treatment specifications clearly point out that tumor markers need to be detected in the process of diagnosis, efficacy evaluation and follow-up. However, there is currently a lack of gastric cancer markers with high sensitivity and specificity, and the detection of markers is limited to a single index analysis, which has many shortcomings such as long analysis time, large reagent consumption, and high detection cost. Therefore, this project will use protein chips to detect new types of gastric cancer patient markers and establish a multi-diagnostic model for early screening of gastric cancer. Finally, monoclonal antibodies will be produced against various high-specific tumor markers and a gastric cancer diagnostic kit will be established.
详细描述
1 Preliminary screening of early gastric cancer markers and antibody verification
(1) Recruitment and sample preparation of patients and healthy people: This project requires four batches of subjects, three batches of healthy people, early gastric cancer and advanced gastric cancer groups, with an average of 30 cases in each group. The other batch (the second batch) is healthy people and 30 cases of chronic atrophic gastritis, early gastric cancer and 30 cases of chronic atrophic gastritis. There were 100 cases in each of the advanced gastric cancer group, and 20 cases in each of liver cancer, colorectal cancer, and breast cancer. Serum and plasma samples obtained from subjects are used to screen potential gastric cancer tumor markers, verify the practicability of established gastric cancer tumor marker diagnostic models and test kits.
- Recruitment of gastric cancer patients: 30 cases of early gastric cancer patients (T1, T2) and advanced gastric cancer patients (T3, T4) are selected respectively. The staging of gastric cancer is based on the eighth edition of UICC (International Union Against Cancer) TNM staging. Subjects were screened according to the requirements of the informed consent form.
- Recruitment of healthy people: 30 volunteers without underlying diseases are selected as healthy control group. Subjects were screened according to the requirements of the informed consent form.
- Sample preparation: intravenous collection to obtain whole blood samples of patients and healthy controls. The sample requirement for each subject is 600ul of serum and plasma.
(2) Antibody chip screening for potential tumor markers of gastric cancer for the first time In order to screen for potential protein markers of gastric cancer, Raybiotech's high-throughput quantitative antibody chip (AAH-BLG-2000) was used to measure 640 in the first batch of subjects (early gastric cancer, advanced gastric cancer, and healthy controls each 30). Kind of human protein. Preliminarily screen out differential proteins, conduct bioinformatics analysis, and finally screen differentially expressed proteins relevant to the research.
2Customized antibody chip to verify gastric cancer tumor markers In order to further verify the candidate tumor markers for the diagnosis of gastric cancer, the differential proteins screened in the previous stage were customized for antibody chips. Use subject serum samples (second batch) for potential biomarker verification. According to the test results, the poorly specific proteins are discarded, and the more specific proteins are retained.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age is greater than or equal to 18 years old (including 18 years old);
- •Patients who are diagnosed with cancer after pathological diagnosis;
- •Can provide enough tissue samples;
- •Have not received anti-tumor treatment in the past;
- •Comply with the principle of informed consent and sign the informed consent form.
- •healthy person:
- •Age is greater than or equal to 18 years old (including 18 years old);
- •No underlying disease;
- •Can provide enough tissue samples;
- •Comply with the principle of informed consent and sign the informed consent form.
排除标准
- •The tumor foci cannot be clearly derived from a specific tumor type;
- •Those who have a history of other tumors, autoimmune diseases and allergies;
- •Previously received anti-tumor treatments such as surgery, chemotherapy, radiotherapy, molecular targeted therapy, immunotherapy, biological therapy or Chinese medicines with anti-cancer and anti-tumor effects in the instructions;
- •Participated in any clinical trial within 90 days before the experiment;
- •Received major surgery within 90 days before the experiment;
- •Received bone marrow transplantation 90 days before the experiment;
- •Subjects who may not be able to complete the study due to other reasons or who are determined by the investigator to be unsuitable to participate in this study.
结局指标
主要结局
Getting serum
时间窗: 2023-12-30
Obtain subject serum
次要结局
未报告次要终点