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Multicenter Prospective Cohort Study of Risk Factors for Gallbladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03762837
Recruitment Status : Not yet recruiting
First Posted : December 4, 2018
Last Update Posted : March 4, 2019
Information provided by (Responsible Party):
Tongji Hospital

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of benign gallbladder disease; according to the national epidemiology of gallbladder cancer Center Clinical Research (unpublished), 2000 National Cholecystoma Clinical Epidemiology Report, and 2005 Clinical Analysis of 2379 Cases of Gallbladder Carcinoma in 17 Hospitals in Five Northwest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

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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

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

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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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03762837

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Contact: Jianming Wang, PHD +86 13507188252
Contact: Yun Lu, MD +86 13971543825

Sponsors and Collaborators
Tongji Hospital
  Study Documents (Full-Text)

Documents provided by Tongji Hospital:
Informed Consent Form  [PDF] August 31, 2018

Additional Information:

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Responsible Party: Tongji Hospital Identifier: NCT03762837    
Other Study ID Numbers: TJ-IRB20181109
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: November 2018

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