A Study of Circulating Exosome Proteomics In Gallbladder Carcinoma Patients

Gallbladder Carcinoma Clinical Trial

— EXOGBC001  

Official title:

A Study of Circulating Exosome Proteomics In Gallbladder Carcinoma Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03581435
• Other study ID #: EXOGBC001
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: July 2018
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Gallbladder Carcinoma
• Gallbladder Neoplasms
• Proteinosis

Locations

Country	Name	City	State
China	Xinhua Hospital	Shanghai	Shanghai

Sponsors (11)

Lead Sponsor

Collaborator

liu yingbin

Bengbu medical college affiliated hospital, First Affiliated Hospital of Xinjiang Medical University, First Hospital of Jilin University, Second Affiliated Hospital of Nanchang University, Shanghai Zhongshan Hosiptal, The Affiliated Hospital of Inner Mongolia Medical University, The affiliated hospital of Jining medical college, The Affiliated Hospital of Tianjin Medical University, The First Affiliated Hospital of Shanxi Medical University, The first affiliated hospital of Zhongshan university

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterization of the protein profile in tumor derived exosomes from the gallbladder carcinoma patients	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.	Up to 2 years from start of study
Primary	The expression of protein A in the circulating exosomes from patients	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.	Up to 2 years from start of study