Dietary Factors and Risk of Gallbladder Carcinoma in China

NCT ID: NCT03546296

Last Updated: 2021-02-01

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

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2022-12-31

Brief Summary

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The purpose of this study is to see how people's diets, other aspects of their lifestyles affect their chances of getting gallbladder carcinoma in China. This survey will enroll 100 patients who have had gallbladder carcinoma,as well as controls with gallstones. The investigators will compare these two groups of subjects to see what factors may lead to gallbladder carcinoma.

Detailed Description

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The investigators will conduct a case-control study in 10 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.

There will be 100 cases with gallbladder carcinoma, 100 controls. The investigators will interview participants about known and potential risk factors for gallbladder carcinoma and obtain information on diet. The investigators will obtain the blood and urine samples for further analysis of metabolomics studies. The investigators will use logistic regression to determine odds ratios for disease with various exposures.

Conditions

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Dietary Habits

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

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
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

Yingbin Liu, MD, PhD, FACS

OTHER

Sponsor Role lead

Responsible Party

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Yingbin Liu, MD, PhD, FACS

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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GBC2017

Identifier Type: -

Identifier Source: org_study_id

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