Dietary Factors and Risk of Gallbladder Carcinoma in China

NCT03546296 | Unknown

• 1 other identifier: GBC2017
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Dietary Habits

Keywords

Dietary Exposure; gallbladder carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Diagnosed with gallbladder carcinoma by imaging tests (cases) Diagnosed with chronic cholecystitis by imaging tests (hospital controls)

You may not qualify if:

• The pathology diagnosis and imaging does not matched Patients with other malignant tumors Patients with other severe systemic diseases

Sponsors & Collaborators

• Yingbin Liu, MD, PhD, FACS: lead
• The First Hospital of Jilin University: collaborator
• Shanghai Zhongshan Hosiptal: collaborator
• The First Affiliated Hospital of Bengbu Medical University: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator
• The Affiliated Hospital of Inner Mongolia Medical University: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• The First Affiliated Hospital of Shanxi Medical University: collaborator
• Jining Medical University: collaborator
• The Affiliated Hospital of Tianjin Medical University: collaborator
• The first affiliated hospital of Zhongshan university: collaborator

Study Sites (1)

Xinhua Hospital

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

We will obtain the blood and urine samples for further analysis of metabolomics studies.

MeSH Terms

Conditions

Feeding Behavior; Gallbladder Neoplasms

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: vice-president，Xinhua Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 6, 2018
• Study Start: January 1, 2017
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: February 1, 2021

Record last verified: 2021-01

Locations

CN (1)