Clinical trial NCT03546296: Dietary Factors and Risk of Gallbladder Carcinoma in China
Official title: Dietary Factors and Risk of Gallbladder Carcinoma in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dietary Habits
Keywords: Dietary Exposure
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: 2018-06-06
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We will conduct a case-control study in 11 hospitals from China. Cases will be the patients with newly-diagnosed gallbladder carcinoma. The hospital 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. The community controls will be matched（1：1） by sex，race and age which will be selected from the same community with the cases.

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.

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: the The demographic, reproductive, and lifestyle characteristics
timeFrame: 2017-2019
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital
state: Shanghai
Study officials:
References: