Gallbladder DiseasesNCT03762837
Multicenter Prospective Cohort Study of Risk Factors for Gallbladder Cancer
An observational study of Gallbladder Diseases and Healthy, run by Tongji Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gallbladder Diseases, Healthy
- What is being tested?
- Benigh gallbladder diseases
- How many people
- 100,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to 31 Dec 2029
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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
- Being tested
- Benigh gallbladder diseases
- Keywords
- Gallbladder cancer
- Medical subject headings
- Gallbladder Diseases, Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benigh gallbladder diseasesOther
We aim to observe the relationship between the benigh gallbladder diseases and gallbladder cancer, and we will not take any actions to interrupt.
| Study group | Role | What they receive |
|---|---|---|
| Exposure group：Benign gallbladder disease | Patients with benign gallbladder diseases, such as gallbladder polyps, gallstones, etc. Receives: Other: Benigh gallbladder diseases | |
| Non-exposed group: healthy people | Patients without benign gallbladder diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gallbladder cancer
Comparison of incidence of gallbladder cancer between the two groups
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start1 Apr 2019 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallbladder DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762837
- Sponsor's protocol ID
- TJ-IRB20181109
- Status last verified
- Nov 2018
- First submitted
- 2 Dec 2018
- Last updated
- 4 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Cohort Study of Risk Factors for Gallbladder Cancer
- ClinicalTrials.gov ID
- NCT03762837
- Acronym / sponsor ID
- TJ-IRB20181109
- Conditions
- Gallbladder Diseases, Healthy
- Keywords
- Gallbladder cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 4 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure group：Benign gallbladder disease | – | Other: Benigh gallbladder diseasesPatients with benign gallbladder diseases, such as gallbladder polyps, gallstones, etc. |
| Non-exposed group: healthy people | – | –Patients without benign gallbladder diseases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Subjects who met the following four criteria entered the study.
Key exclusion criteria (3 listed)
- Subjects can not enter the study by combining any of the following
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Benigh gallbladder diseasesWe aim to observe the relationship between the benigh gallbladder diseases and gallbladder cancer, and we will not take any actions to interrupt. | Other | Exposure group：Benign gallbladder disease |
Primary outcome
Gallbladder cancer
Time frame: 3 years
Comparison of incidence of gallbladder cancer between the two groups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Gallbladder Diseases and Healthy, run by Tongji Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianming Wang, PHD (+86 13507188252, wjm18jgm@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gallbladder cancer (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2019; AzTrials last refreshed its copy on 26 Oct 2026.