Multicenter Prospective Cohort Study of Risk Factors for Gallbladder Cancer
1 other identifier
observational
100,000
0 countries
N/A
Brief Summary
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of benign gallbladder disease; according to the national epidemiology of gallbladder cancer Center Clinical Research (unpublished), 2000 National Cholecystoma Clinical Epidemiology Report, and 2005 Clinical Analysis of 2379 Cases of Gallbladder Carcinoma in 17 Hospitals in Five Northwest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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2019
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2018
CompletedFirst Posted
Study publicly available on registry
December 4, 2018
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
ExpectedMarch 4, 2019
November 1, 2018
3.8 years
December 2, 2018
February 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gallbladder cancer
Comparison of incidence of gallbladder cancer between the two groups
3 years
Study Arms (2)
Exposure group：Benign gallbladder disease
Patients with benign gallbladder diseases, such as gallbladder polyps, gallstones, etc.
Non-exposed group: healthy people
Patients without benign gallbladder diseases
Interventions
We aim to observe the relationship between the benigh gallbladder diseases and gallbladder cancer, and we will not take any actions to interrupt.
Eligibility Criteria
The recruits included patients with benign gallbladder cancer and healthy people, mainly from the Grade-A Tertiary Hospitals and medical centers in China.
You may qualify if:
- 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;
- Sign the informed consent form. PS: If someone meets the condition (1) or (2), then he can be enrolled.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tongji Hospitallead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2018
First Posted
December 4, 2018
Study Start
April 1, 2019
Primary Completion
December 31, 2022
Study Completion (Estimated)
December 31, 2029
Last Updated
March 4, 2019
Record last verified: 2018-11