Multicenter Prospective Cohort Study of Risk Factors for Gallbladder Cancer

NCT ID: NCT03762837

Last Updated: 2019-03-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2029-12-31

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of benign gallbladder disease; according to the national epidemiology of gallbladder cancer Center Clinical Research (unpublished), 2000 National Cholecystoma Clinical Epidemiology Report, and 2005 Clinical Analysis of 2379 Cases of Gallbladder Carcinoma in 17 Hospitals in Five Northwest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.

Detailed Description

Gallbladder cancer is the most common malignant biliary tract tumor. The main risk factors for gallbladder cancer include gallstones, gallbladder polyps, gallbladder adenomas, chronic inflammation of the gallbladder, etc. However, recently, there is still a lack of evaluation data on relevant risk factors. Therefore, on the basis of large-scale epidemiological investigations, large-scale prospective studies are needed to further clarify the level of risk factors associated with gallbladder cancer. With the development of modern imaging technology and deep understanding of gallbladder diseases, the detection rate of benign gallbladder lesions (cacerous polyps, gallbladder adenomyosis, gallbladder adenoma, gallstones, etc.) has increased year by year, and some benign gallbladder lesions can pass A series of pathophysiological processes have gradually evolved into gallbladder cancer. This study aimed to establish a prospective cohort of benign gallbladder disease, to explore the correlation, intervention time and socioeconomic benefits of benign gallbladder disease and gallbladder cancer. In order to further understand the current trend and diagnosis and treatment of benign gallbladder disease in China, the Chinese Society of Surgery Branch of the Chinese Society of Surgery will launch a national epidemiological survey of gallbladder cancer (2018). This study will provide a more detailed basis for the diagnosis and treatment of benign gallbladder disease in China.

Conditions

Gallbladder Diseases; Healthy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Exposure group：Benign gallbladder disease

Patients with benign gallbladder diseases, such as gallbladder polyps, gallstones, etc.

Benigh gallbladder diseases

Intervention Type: OTHER

We aim to observe the relationship between the benigh gallbladder diseases and gallbladder cancer, and we will not take any actions to interrupt.

Non-exposed group: healthy people

Patients without benign gallbladder diseases

No interventions assigned to this group

Interventions

Benigh gallbladder diseases

We aim to observe the relationship between the benigh gallbladder diseases and gallbladder cancer, and we will not take any actions to interrupt.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Subjects who met the following four criteria entered the study.

1. A benign gallbladder disease is detected during a medical examination or visit (according to any imaging test);

2. healthy people without gallbladder disease;

3. Age greater than 18 years and less than 80 years old;

4. Sign the informed consent form. PS: If someone meets the condition (1) or (2), then he can be enrolled.

Exclusion Criteria

• Subjects can not enter the study by combining any of the following

1. Concomitant diseases such as severe mental illness, severe heart, lung and kidney;

2. Refusal of follow-up requirements.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tongji Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jianming Wang, PHD

Role: CONTACT

wjm18jgm@aliyun.com

+86 13507188252

Yun Lu, MD

Role: CONTACT

drlyly@163.com

+86 13971543825

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

TJ-IRB20181109

Identifier Type: -

Identifier Source: org_study_id