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临床试验/NCT03581435
NCT03581435Unknown不适用

A Study of Circulating Exosome Proteomics In Gallbladder Carcinoma Patients

liu yingbin1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
The expression of protein A in the circulating exosomes from patients

研究概览

简要总结

This research will be the first study for exosome purified from blood in gallbladder carcinoma patients. Proteomics studies will be done in both tumor tissue and the circulating exosome from blood specimens. Then, the potential prognostic and predictive biomarkers will be searched by bioinformatics to find the correlations between exosome biomarkers and gallbladder carcinoma.

详细描述

Background:

Exosomes are formed by inward budding of late endosomes, producing multivesicular bodies (MVBs), and are released into the environment by fusion of the MVBs with the plasma membrane. It has been demonstrated that the content and function of exosomes depends on the originating cell and the conditions under which they are produced. Tumor exosome production, transfer and education of bone marrow cells supports tumor growth and metastasis.

Aims of the study:

Proteomics studies will be done in both tumor tissue and the circulating exosome from the gallbladder carcinoma patients. Then, the potential prognostic and predictive biomarkers will be searched by bioinformatics to find the correlations between exosome biomarkers and gallbladder carcinoma.

Materials and Methods:

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with gallbladder carcinoma by imaging tests (cases) Diagnosed with chronic cholecystitis by imaging tests (hospital controls)

排除标准

  • The pathology diagnosis and imaging does not matched Patients with other malignant tumors Patients with other severe systemic diseases

结局指标

主要结局

The expression of protein A in the circulating exosomes from patients

时间窗: Up to 2 years from start of study

The expression of protein A (which is selected from outcome 1) in the circulating exosomes from patients will be detected by flow cytometry analysis. The ROC curve of A+ circulating exosomes will be done to compare with the clinical standard tumour biomarker (e.g. CA199) for patients with gallbladder carcinoma patients.

Characterization of the protein profile in tumor derived exosomes from the gallbladder carcinoma patients

时间窗: Up to 2 years from start of study

Proteomics studies will be done in both tumor tissue and the circulating exosomes from blood specimens. The specific protein A in the circulating exosomes from the gallbladder carcinoma patients will be selected for further analysis.

次要结局

未报告次要终点

研究者

发起方
liu yingbin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

liu yingbin

vice-president,Xinhua Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China

Shanghai Jiao Tong University School of Medicine

研究点 (1)

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