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Dietary Factors and Risk of Gallbladder Carcinoma in China (DRGBC001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03546296
Recruitment Status : Recruiting
First Posted : June 6, 2018
Last Update Posted : February 1, 2021
Sponsor:
Collaborators:
The First Hospital of Jilin University
Shanghai Zhongshan Hosiptal
First Affiliated Hospital Bengbu Medical College
Second Affiliated Hospital of Nanchang University
The Affiliated Hospital of Inner Mongolia Medical University
First Affiliated Hospital of Xinjiang Medical University
The First Affiliated Hospital of Shanxi Medical University
The affiliated hospital of Jining medical college
The Affiliated Hospital of Tianjin Medical University
The first affiliated hospital of Zhongshan university
Information provided by (Responsible Party):
Yingbin Liu, MD, PhD, FACS, Shanghai Jiao Tong University School of Medicine

Study Description
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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.

Condition or disease
Dietary Habits

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 Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Dietary Factors and Risk of Gallbladder Carcinoma in China
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. the The demographic, reproductive, and lifestyle characteristics [ Time Frame: 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.


Biospecimen Retention:   Samples Without DNA
We will obtain the blood and urine samples for further analysis of metabolomics studies.

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03546296


Locations
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China, Shanghai
Xinhua Hospital Recruiting
Shanghai, Shanghai, China, 200092
Contact: yingbin liu    13918803900    laoniulyb@163.com   
Sponsors and Collaborators
Yingbin Liu, MD, PhD, FACS
The First Hospital of Jilin University
Shanghai Zhongshan Hosiptal
First Affiliated Hospital Bengbu Medical College
Second Affiliated Hospital of Nanchang University
The Affiliated Hospital of Inner Mongolia Medical University
First Affiliated Hospital of Xinjiang Medical University
The First Affiliated Hospital of Shanxi Medical University
The affiliated hospital of Jining medical college
The Affiliated Hospital of Tianjin Medical University
The first affiliated hospital of Zhongshan university
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Yingbin Liu, MD, PhD, FACS, vice-president，Xinhua Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03546296    
Other Study ID Numbers: GBC2017
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: February 1, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yingbin Liu, MD, PhD, FACS, Shanghai Jiao Tong University School of Medicine:
Dietary Exposure
gallbladder carcinoma
Additional relevant MeSH terms:
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Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms