Multicenter Prospective Cohort Study of Risk Factors for Gallbladder Cancer

• ClinicalTrials.gov Identifier: NCT03762837
• Recruitment Status: Not yet recruiting
• First Posted: December 4, 2018
• Last Update Posted: March 4, 2019
• Sponsor: Tongji Hospital
• Information provided by (Responsible Party): Tongji Hospital

Study Description

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of benign gallbladder disease; according to the national epidemiology of gallbladder cancer Center Clinical Research (unpublished), 2000 National Cholecystoma Clinical Epidemiology Report, and 2005 Clinical Analysis of 2379 Cases of Gallbladder Carcinoma in 17 Hospitals in Five Northwest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

Condition or disease	Intervention/treatment
Gallbladder Diseases; Healthy	Other: Benigh gallbladder diseases

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.

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 100000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 10 Years
• Official Title: Multicenter Prospective Cohort Study of Risk Factors for Gallbladder Cancer
• Estimated Study Start Date: April 1, 2019
• Estimated Primary Completion Date: December 31, 2022
• Estimated Study Completion Date: December 31, 2029

Groups and Cohorts

Group/Cohort	Intervention/treatment
Exposure group：Benign gallbladder disease; Patients with benign gallbladder diseases, such as gallbladder polyps, gallstones, etc.	Other: 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.
Non-exposed group: healthy people; Patients without benign gallbladder diseases

Outcome Measures

Primary Outcome Measures :

1. Gallbladder cancer [ Time Frame: 3 years ]
   Comparison of incidence of gallbladder cancer between the two groups

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

The recruits included patients with benign gallbladder cancer and healthy people, mainly from the Grade-A Tertiary Hospitals and medical centers in China.

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.

Contacts and Locations

Contacts

Contact: Jianming Wang, PHD; +86 13507188252; wjm18jgm@aliyun.com

Contact: Yun Lu, MD; +86 13971543825; drlyly@163.com

Sponsors and Collaborators

Tongji Hospital

  Study Documents (Full-Text)

Documents provided by Tongji Hospital:

Informed Consent Form  [PDF] August 31, 2018

Study Protocol and Statistical Analysis Plan  [PDF] August 31, 2018

More Information

Additional Information:

• Responsible Party: Tongji Hospital
• ClinicalTrials.gov Identifier: NCT03762837
• Other Study ID Numbers: TJ-IRB20181109
• First Posted: December 4, 2018
• Last Update Posted: March 4, 2019
• Last Verified: November 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tongji Hospital:

Gallbladder cancer

Additional relevant MeSH terms:

Gallbladder Neoplasms; Gallbladder Diseases; Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases