Dietary HabitsDRGBC001NCT03546296
Dietary Factors and Risk of Gallbladder Carcinoma in China
An observational study of Dietary Habits, run by Yingbin Liu, MD, PhD, FACS at 1 site in China.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dietary Habits
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Diagnosed with gallbladder carcinoma by imaging tests (cases) Diagnosed with chronic cholecystitis by imaging tests (hospital controls)
Who cannot join
- The pathology diagnosis and imaging does not matched Patients with other malignant tumors Patients with other severe systemic diseases
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xinhua Hospital
Shanghai, Shanghai Municipality, 200092
yingbin liu, 13918803900, laoniulyb@163.com
About this study
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.
Read the 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.
- Conditions
- Dietary Habits
- Keywords
- Dietary Exposure, gallbladder carcinoma
- Medical subject headings
- Feeding Behavior, Gallbladder Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2017-2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start1 Jan 2017
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary HabitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yingbin Liu, MD, PhD, FACS
- Sponsor type
- University, hospital or other
- Collaborators
- The First Hospital of Jilin University, Shanghai Zhongshan Hosiptal, The First Affiliated Hospital of Bengbu Medical University, 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, Affiliated Hospital of Jining Medical University, The Affiliated Hospital of Tianjin Medical University, The first affiliated hospital of Zhongshan university
- Responsible party
- Sponsor-investigator, Yingbin Liu, MD, PhD, FACS, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546296
- Sponsor's protocol ID
- GBC2017
- Acronym
- DRGBC001
- Status last verified
- Jan 2021
- First submitted
- 23 May 2018
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Factors and Risk of Gallbladder Carcinoma in China
- ClinicalTrials.gov ID
- NCT03546296
- Acronym / sponsor ID
- DRGBC001 / GBC2017
- Conditions
- Dietary Habits
- Keywords
- Dietary Exposure, gallbladder carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yingbin Liu, MD, PhD, FACSUniversity, hospital or other
- Collaborators
- The First Hospital of Jilin University, Shanghai Zhongshan Hosiptal, The First Affiliated Hospital of Bengbu Medical University, 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, Affiliated Hospital of Jining Medical University, The Affiliated Hospital of Tianjin Medical University, The first affiliated hospital of Zhongshan university
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 6 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Diagnosed with gallbladder carcinoma by imaging tests (cases) Diagnosed with chronic cholecystitis by imaging tests (hospital controls)
Key exclusion criteria (1 listed)
- The pathology diagnosis and imaging does not matched Patients with other malignant tumors Patients with other severe systemic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dietary Habits, run by Yingbin Liu, MD, PhD, FACS at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the The demographic, reproductive, and lifestyle characteristics (time frame: 2017-2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021.