Gallbladder Carcinoma, Proteinosis
Conditions
Brief summary
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.
Detailed description
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: The investigators will conduct a case-control study in 11 hospitals from China. Cases will be the patients with newly-diagnosed gallbladder carcinoma. The controls will be matched （1：1）by sex，race and age which will be selected from the patients receiving cholecystectomy due to gallstones from the same hospital with the cases. A total of 50 patients with gallbladder carcinoma will be recruited. The investigators will obtain the blood and tumor tissue samples for further analysis of proteomics studies. Exosome from blood specimens will be isolated and purified by sucrose gradient ultracentrifugation. The potential prognostic and predictive biomarkers will be searched by bioinformatics to find the correlations between exosome biomarkers and gallbladder carcinoma. Data will be collected from January 2018 to December 2018.
Interventions
None listed
Sponsors
The First Hospital of Jilin University
Shanghai Zhongshan Hosiptal
The First Affiliated Hospital of Bengbu Medical University
Second Affiliated Hospital of Nanchang University
The Affiliated Hospital of Inner Mongolia Medical University
First Affiliated Hospital of Xinjiang Medical University
The First Affiliated Hospital of Shanxi Medical University
Jining Medical University
The Affiliated Hospital of Tianjin Medical University
The first affiliated hospital of Zhongshan university
liu yingbin
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Diagnosed with gallbladder carcinoma by imaging tests (cases) Diagnosed with chronic cholecystitis by imaging tests (hospital controls)
Exclusion criteria
* The pathology diagnosis and imaging does not matched Patients with other malignant tumors Patients with other severe systemic diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characterization of the protein profile in tumor derived exosomes from the gallbladder carcinoma patients | 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. |
| The expression of protein A in the circulating exosomes from patients | 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. |
Countries
China
Outcome results
None listed