<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03762837</url>
  </required_header>
  <id_info>
    <org_study_id>TJ-IRB20181109</org_study_id>
    <nct_id>NCT03762837</nct_id>
  </id_info>
  <brief_title>Multicenter Prospective Cohort Study of Risk Factors for Gallbladder Cancer</brief_title>
  <official_title>Multicenter Prospective Cohort Study of Risk Factors for Gallbladder Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tongji Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tongji Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial is a prospective study, the main purpose of the study is to investigate the&#xD;
      association between benign gallbladder disease and gallbladder carcinoma; to explain the&#xD;
      timing of intervention, intervention and early prevention of benign gallbladder disease;&#xD;
      according to the national epidemiology of gallbladder cancer Center Clinical Research&#xD;
      (unpublished), 2000 National Cholecystoma Clinical Epidemiology Report, and 2005 Clinical&#xD;
      Analysis of 2379 Cases of Gallbladder Carcinoma in 17 Hospitals in Five Northwest Provinces,&#xD;
      Pre-experimental data, using samples The volume estimation formula, α = 0.05, β = 0.1, plans&#xD;
      to enroll 100,000 people.Half of participants is someone with Biliary benign disease，while&#xD;
      the other half is healthy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gallbladder cancer is the most common malignant biliary tract tumor. The main risk factors&#xD;
      for gallbladder cancer include gallstones, gallbladder polyps, gallbladder adenomas, chronic&#xD;
      inflammation of the gallbladder, etc. However, recently, there is still a lack of evaluation&#xD;
      data on relevant risk factors. Therefore, on the basis of large-scale epidemiological&#xD;
      investigations, large-scale prospective studies are needed to further clarify the level of&#xD;
      risk factors associated with gallbladder cancer. With the development of modern imaging&#xD;
      technology and deep understanding of gallbladder diseases, the detection rate of benign&#xD;
      gallbladder lesions (cacerous polyps, gallbladder adenomyosis, gallbladder adenoma,&#xD;
      gallstones, etc.) has increased year by year, and some benign gallbladder lesions can pass A&#xD;
      series of pathophysiological processes have gradually evolved into gallbladder cancer. This&#xD;
      study aimed to establish a prospective cohort of benign gallbladder disease, to explore the&#xD;
      correlation, intervention time and socioeconomic benefits of benign gallbladder disease and&#xD;
      gallbladder cancer. In order to further understand the current trend and diagnosis and&#xD;
      treatment of benign gallbladder disease in China, the Chinese Society of Surgery Branch of&#xD;
      the Chinese Society of Surgery will launch a national epidemiological survey of gallbladder&#xD;
      cancer (2018). This study will provide a more detailed basis for the diagnosis and treatment&#xD;
      of benign gallbladder disease in China.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">April 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2029</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>Gallbladder cancer</measure>
    <time_frame>3 years</time_frame>
    <description>Comparison of incidence of gallbladder cancer between the two groups</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100000</enrollment>
  <condition>Gallbladder Diseases</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Exposure group：Benign gallbladder disease</arm_group_label>
    <description>Patients with benign gallbladder diseases, such as gallbladder polyps, gallstones, etc.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-exposed group: healthy people</arm_group_label>
    <description>Patients without benign gallbladder diseases</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Benigh gallbladder diseases</intervention_name>
    <description>We aim to observe the relationship between the benigh gallbladder diseases and gallbladder cancer, and we will not take any actions to interrupt.</description>
    <arm_group_label>Exposure group：Benign gallbladder disease</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The recruits included patients with benign gallbladder cancer and healthy people, mainly&#xD;
        from the Grade-A Tertiary Hospitals and medical centers in China.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who met the following four criteria entered the study.&#xD;
&#xD;
               1. A benign gallbladder disease is detected during a medical examination or visit&#xD;
                  (according to any imaging test);&#xD;
&#xD;
               2. healthy people without gallbladder disease;&#xD;
&#xD;
               3. Age greater than 18 years and less than 80 years old;&#xD;
&#xD;
               4. Sign the informed consent form. PS: If someone meets the condition (1) or (2),&#xD;
                  then he can be enrolled.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects can not enter the study by combining any of the following&#xD;
&#xD;
               1. Concomitant diseases such as severe mental illness, severe heart, lung and&#xD;
                  kidney;&#xD;
&#xD;
               2. Refusal of follow-up requirements.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jianming Wang, PHD</last_name>
    <phone>+86 13507188252</phone>
    <email>wjm18jgm@aliyun.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yun Lu, MD</last_name>
    <phone>+86 13971543825</phone>
    <email>drlyly@163.com</email>
  </overall_contact_backup>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>December 2, 2018</study_first_submitted>
  <study_first_submitted_qc>December 2, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>February 28, 2019</last_update_submitted>
  <last_update_submitted_qc>February 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gallbladder cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gallbladder Neoplasms</mesh_term>
    <mesh_term>Gallbladder Diseases</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 31, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/37/NCT03762837/ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 31, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/37/NCT03762837/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03762837
org study id: TJ-IRB20181109
nct id: NCT03762837
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Gallbladder cancer
time frame: 3 years
description: Comparison of incidence of gallbladder cancer between the two groups
arm group label: Exposure group：Benign gallbladder disease
description: Patients with benign gallbladder diseases, such as gallbladder polyps, gallstones, etc.
arm group label: Non-exposed group: healthy people
description: Patients without benign gallbladder diseases
intervention type: Other
intervention name: Benigh gallbladder diseases
description: We aim to observe the relationship between the benigh gallbladder diseases and gallbladder cancer, and we will not take any actions to interrupt.
arm group label: Exposure group：Benign gallbladder disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jianming Wang, PHD
phone: +86 13507188252
email: wjm18jgm@aliyun.com
last name: Yun Lu, MD
phone: +86 13971543825
email: drlyly@163.com
responsible party type: Sponsor
mesh term: Gallbladder Neoplasms
mesh term: Gallbladder Diseases
provided document: 
provided document: 