Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-25 @ 7:44 PM
Study NCT ID:
NCT03581435
Status:
UNKNOWN
Last Update Posted:
2018-07-10
First Post:
2018-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Circulating Exosome Proteomics In Gallbladder Carcinoma Patients
Sponsor:
liu yingbin
Organization:
Study Overview
Official Title:
A Study of Circulating Exosome Proteomics In Gallbladder Carcinoma Patients
Status:
UNKNOWN
Status Verified Date:
2018-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXOGBC001
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: