A Study of Circulating Exosome Proteomics In Gallbladder Carcinoma Patients (EXOGBC001)

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.

Study Overview

• Status: Unknown
• Conditions: Gallbladder Carcinoma; Proteinosis

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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200092
      • Recruiting
      • Xinhua Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
gallbladder carcinoma patients; Cases will be the patients with newly-diagnosed gallbladder carcinoma.
The controls; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: liu yingbin
• Collaborators: The First Hospital of Jilin University; The First Affiliated Hospital of Shanxi Medical University; The Affiliated Hospital of Tianjin Medical University; First Affiliated Hospital of Xinjiang Medical University; First Affiliated Hospital Bengbu Medical College; Second Affiliated Hospital of Nanchang University; The Affiliated Hospital of Inner Mongolia Medical University; The first affiliated hospital of Zhongshan university; Shanghai Zhongshan Hosiptal; The affiliated hospital of Jining medical college

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ANTICIPATED): December 30, 2018
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: June 26, 2018
• First Submitted That Met QC Criteria: July 8, 2018
• First Posted (ACTUAL): July 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 10, 2018
• Last Update Submitted That Met QC Criteria: July 8, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Gallbladder Diseases; Biliary Tract Diseases; Biliary Tract Neoplasms; Carcinoma; Gallbladder Neoplasms
• Other Study ID Numbers: EXOGBC001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No