EXOGBC001: A Study of Circulating Exosome Proteomics In Gallbladder Carcinoma Patients

Sponsor

liu yingbin (Other)

Overall Status

Unknown status

CT.gov ID

NCT03581435

Collaborator

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

Enrollment

Location

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Proteinosis 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

A Study of Circulating Exosome Proteomics In Gallbladder Carcinoma Patients

Actual Study Start Date :

Jan 1, 2018

Anticipated Primary Completion Date :

Dec 30, 2018

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xinhua Hospital	Shanghai	Shanghai	China	200092

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

liu yingbin, vice-president，Xinhua Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China, Shanghai Jiao Tong University School of Medicine

ClinicalTrials.gov Identifier:

NCT03581435

Other Study ID Numbers:

EXOGBC001

First Posted:

Jul 10, 2018

Last Update Posted: