A Study of Circulating Exosome Proteomics In Gallbladder Carcinoma Patients

NCT ID: NCT03581435

Last Updated: 2018-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-12-01

Brief Summary

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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

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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.

Conditions

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Proteinosis Gallbladder Carcinoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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gallbladder carcinoma patients

Cases will be the patients with newly-diagnosed gallbladder carcinoma.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The First Hospital of Jilin University

OTHER

Sponsor Role collaborator

Shanghai Zhongshan Hosiptal

UNKNOWN

Sponsor Role collaborator

The First Affiliated Hospital of Bengbu Medical University

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Nanchang University

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Inner Mongolia Medical University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Xinjiang Medical University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Shanxi Medical University

OTHER

Sponsor Role collaborator

Jining Medical University

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Tianjin Medical University

UNKNOWN

Sponsor Role collaborator

The first affiliated hospital of Zhongshan university

UNKNOWN

Sponsor Role collaborator

liu yingbin

OTHER

Sponsor Role lead

Responsible Party

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liu yingbin

vice-president,Xinhua Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Xinhua Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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yingbin liu

Role: primary

13918803900

Other Identifiers

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EXOGBC001

Identifier Type: -

Identifier Source: org_study_id

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