Clinical trial NCT03581435: A Study of Circulating Exosome Proteomics In Gallbladder Carcinoma Patients
Official title: A Study of Circulating Exosome Proteomics In Gallbladder Carcinoma Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Proteinosis
Gallbladder Carcinoma
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: The First Hospital of Jilin University
name: Shanghai Zhongshan Hosiptal
name: The First Affiliated Hospital of Bengbu Medical University
name: Second Affiliated Hospital of Nanchang University
name: The Affiliated Hospital of Inner Mongolia Medical University
name: First Affiliated Hospital of Xinjiang Medical University
name: The First Affiliated Hospital of Shanxi Medical University
name: Jining Medical University
name: The Affiliated Hospital of Tianjin Medical University
name: The first affiliated hospital of Zhongshan university
First posted: 2018-07-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Characterization of the protein profile in tumor derived exosomes from the gallbladder carcinoma patients
timeFrame: Up to 2 years from start of study
measure: The expression of protein A in the circulating exosomes from patients
timeFrame: Up to 2 years from start of study
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital
state: Shanghai
Study officials:
References: