Dietary Factors and Risk of Gallbladder Carcinoma in China

Dietary Habits Clinical Trial

— DRGBC001  

Official title:

Dietary Factors and Risk of Gallbladder Carcinoma in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03546296
• Other study ID #: GBC2017
• Status: Recruiting
• Start date: January 1, 2017
• Est. completion date: December 2022

Study information

• Verified date: January 2021
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Dietary Habits

Locations

Country	Name	City	State
China	Xinhua Hospital	Shanghai	Shanghai

Sponsors (11)

Lead Sponsor

Collaborator

Yingbin Liu, MD, PhD, FACS

First Affiliated Hospital Bengbu Medical College, First Affiliated Hospital of Xinjiang Medical University, First Hospital of Jilin University, Second Affiliated Hospital of Nanchang University, Shanghai Zhongshan Hosiptal, The Affiliated Hospital of Inner Mongolia Medical University, The affiliated hospital of Jining medical college, The Affiliated Hospital of Tianjin Medical University, The First Affiliated Hospital of Shanxi Medical University, The first affiliated hospital of Zhongshan university

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the The demographic, reproductive, and lifestyle characteristics	Cases and controls were interviewed by one of three research assistants with a standard questionnaire to elicit information about demographic, reproductive, and lifestyle characteristics.	2017-2019