Multicenter Prospective Cohort Study of Risk Factors for Gallbladder Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTongji Hospital
About this trial
This trial is a prospective study, the main purpose of the study is to investigate the association between benign gallbladder disease and gallbladder carcinoma; to explain the timing of intervention, intervention and early prevention of benign gallbladder disease; according to the national epidemiology of gallbladder cancer Center Clinical Research (unpublished), 2000 National Cholecystoma Clinical Epidemiology Report, and 2005 Clinical Analysis of 2379 Cases of Gallbladder Carcinoma in 17 Hospitals in Five Northwest Provinces, Pre-experimental data, using samples The volume estimation formula, α = 0.05, β = 0.1, plans to enroll 100,000 people.Half of participants is someone with Biliary benign disease，while the other half is healthy.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subjects who met the following four criteria entered the study.
A benign gallbladder disease is detected during a medical examination or visit (according to any imaging test);
healthy people without gallbladder disease;
Age greater than 18 years and less than 80 years old;
Disqualifiers
Subjects can not enter the study by combining any of the following
Concomitant diseases such as severe mental illness, severe heart, lung and kidney;
Refusal of follow-up requirements.
Trial population
The recruits included patients with benign gallbladder cancer and healthy people, mainly from the Grade-A Tertiary Hospitals and medical centers in China.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Benigh gallbladder diseases
Other interventionWe aim to observe the relationship between the benigh gallbladder diseases and gallbladder cancer, and we will not take any actions to interrupt.
Treatment groups
100,000 Participants
are divided into 2 treatment groupsGroup A: Exposure group：Benign gallbladder disease1 intervention
Group B: Non-exposed group: healthy people0 interventions
Trial outcomes
Primary outcomes
1
Gallbladder cancer
Comparison of incidence of gallbladder cancer between the two groups
Time frame
3 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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