Dietary Factors and Risk of Gallbladder Carcinoma in China

• Conditions: Dietary Habits

• Registration Number: NCT03546296
• Lead Sponsor: Yingbin Liu, MD, PhD, FACS

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2018-05-23
• Study First Submitted QC: 2018-05-23
• Study First Posted: 2018-06-06
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-02-01
• Primary Completion: 2021-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the The demographic, reproductive, and lifestyle characteristics	2017-2019	Cases and controls were interviewed by one of three research assistants with a standard questionnaire to elicit information about demographic, reproductive, and lifestyle characteristics.

Trial Locations

Locations (1)

Xinhua Hospital; 🇨🇳 Shanghai, Shanghai, China