<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/NCT02216955</url>
  </required_header>
  <id_info>
    <org_study_id>cdk-201002</org_study_id>
    <nct_id>NCT02216955</nct_id>
  </id_info>
  <brief_title>Nutrition and Lifestyle Study Cohort of Gastric Cancer in China</brief_title>
  <official_title>Impact of Nutrition, Dietary Pattern, Obesity, Physical Activity, Depression, Diabetes, Aspirin Use and Vitamin Supplement in Colorectal Cancer in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>State Key Laboratory of Cancer Biology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tang-Du Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tianjin Union Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chengdu Medical College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beihua University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Military Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>China-Japan Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University Cancer Hospital &amp; Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Third Military Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>State Key Laboratory of Cancer Biology</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      China has the largest gastric cancer patients population all over the world. Recent reports&#xD;
      concluded nutrition status and lifestyle factors were associated with gastric cancer risk,&#xD;
      however, the influence of nutrition and lifestyle factors on cancer outcome in gastric cancer&#xD;
      survivors is largely unknown.The investigators will explore the impact of nutrition status,&#xD;
      life style, dietary pattern, obesity, physical activity, depression, diabetes, aspirin use&#xD;
      and vitamin supplement on gastric cancer outcome. The investigators will recruit&#xD;
      approximately 50,000 patients as a prospective study cohort. During follow up, the&#xD;
      investigators will explore the association of these factors with disease-specific survival,&#xD;
      disease-free survival and overall survival of patients. The investigators believe that this&#xD;
      project will facilitate the establishment of domestic nutrition and lifestyle data of gastric&#xD;
      cancer of China, and the improvement of the quality of clinical management of patients with&#xD;
      gastric cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background - Gastric cancer incidence is increasing at an alarming rate in China. Recent&#xD;
      studies reported that nutrition status and lifestyle factors such as dietary pattern,&#xD;
      obesity, physical activity, depression, diabetes, aspirin use and vitamin supplement were&#xD;
      associated cancer risk. Yet, the influence of nutrition and lifestyle factors on gastric&#xD;
      cancer outcome (i.e. recurrence and survival) in gastric cancer survivors is largely unknown.&#xD;
      And there is currently no large cohort studies investigated the impact of these factors on&#xD;
      gastric cancer outcomes in China.&#xD;
&#xD;
      Objectives - Our study aims to evaluate the impact of nutrition status and lifestyle factors&#xD;
      such as dietary pattern, tea consumption, obesity, physical activity, depression, diabetes,&#xD;
      aspirin use and vitamin supplement on gastric cancer outcome (disease-specific survival,&#xD;
      disease-free survival and overall survival).&#xD;
&#xD;
      Settings and methods - The study will recruit approximately 50,000 participants with gastric&#xD;
      cancer from 12 public hospitals in China after informed consent. Appropriate questionnaires&#xD;
      will be utilized to evaluate nutrition status and lifestyle factors such as dietary pattern,&#xD;
      tea consumption, obesity, physical activity, depression, diabetes, aspirin use and vitamin&#xD;
      supplement. The association of disease-specific survival, disease-free survival and overall&#xD;
      survival with these factors will be evaluated.&#xD;
&#xD;
      Impact - To the best of our knowledge, this is the first large cohort, systematically&#xD;
      investigation of the impact of nutrition status and lifestyle factors on gastric cancer&#xD;
      outcome. When complete, our investigation would supply a systematical and precise&#xD;
      understanding of the impact nutrition status and lifestyle factors on cancer out come in&#xD;
      China.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2009</start_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Disease-specific survival</measure>
    <time_frame>7 years</time_frame>
    <description>Disease-specific survival is defined as the time elapsed from surgery to death due to gastric cancer. Concretely, the cause of death obtained in the follow up was classified according to ICD-10 conventions. Disease-specific deaths included those with an underlying cause attributed to ICD-10 codes C18.0-C20.0 or C26.0.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>7 years</time_frame>
    <description>Overall survival is defined as the time elapsed from surgery to the date of death from any cause</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Disease-free survival</measure>
    <time_frame>7 years</time_frame>
    <description>Disease-free survival is defined as the time elapsed from surgery to the first occurrence of any of the following events: recurrence of gastric cancer; gastric cancer distant metastasis; development of second non-colorectal malignancy excluding basal cell carcinomas of the skin and carcinoma in situ of the cervix; or death from any cause without documentation of a cancer-related event.</description>
  </other_outcome>
  <enrollment type="Anticipated">50000</enrollment>
  <condition>Gastric Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The investigators will recruit about 50,000 patients with gastric cancer in 12 hospitals of&#xD;
        China&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient must have a histologically proven adenocarcinoma of gastric cancer.&#xD;
&#xD;
          -  Patients must have a performance status of 0,1, or 2 by the Southwest Oncology Group&#xD;
             criteria.&#xD;
&#xD;
          -  Patients must have recovered from any effects of surgery.&#xD;
&#xD;
          -  Evaluable disease must be present outside radiation field. At least 3 weeks must have&#xD;
             elapsed after discontinuation of radiation therapy.&#xD;
&#xD;
          -  Patients must provide a signed consent to participate in the study.&#xD;
&#xD;
          -  Patients must complete all questionnaires.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a proven history of peptic ulcer disease or gastroesophageal reflux.&#xD;
&#xD;
          -  History of other malignancy, except for cancers that have been treated with a curative&#xD;
             intent and patient is without evidence of active disease.&#xD;
&#xD;
          -  Unresolved bacterial infection requiring treatment with antibiotics.&#xD;
&#xD;
          -  Pregnant or lactating women may not participate in the study.&#xD;
&#xD;
          -  Patients known to have HIV-1 virus infection because of the undetermined effect of&#xD;
             this chemotherapy regimen in patients with HIV-1 and the potential for serious&#xD;
             interaction with anti-HIV medications..&#xD;
&#xD;
          -  Other serious concurrent infection&#xD;
&#xD;
          -  Clinically significant cardiac disease not well controlled with medication (e.g.&#xD;
             congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias)&#xD;
             or myocardial infarction within the last 12 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Dake Chu, M.D.</last_name>
    <email>chudake@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>State Key laboratory of Cancer Biology</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dake Chu, M.D.</last_name>
      <email>chudake@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>February 18, 2018</last_update_submitted>
  <last_update_submitted_qc>February 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>State Key Laboratory of Cancer Biology</investigator_affiliation>
    <investigator_full_name>Dake Chu</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT02216955
org study id: cdk-201002
nct id: NCT02216955
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
China has the largest gastric cancer patients population all over the world. Recent reports
      concluded nutrition status and lifestyle factors were associated with gastric cancer risk,
      however, the influence of nutrition and lifestyle factors on cancer outcome in gastric cancer
      survivors is largely unknown.The investigators will explore the impact of nutrition status,
      life style, dietary pattern, obesity, physical activity, depression, diabetes, aspirin use
      and vitamin supplement on gastric cancer outcome. The investigators will recruit
      approximately 50,000 patients as a prospective study cohort. During follow up, the
      investigators will explore the association of these factors with disease-specific survival,
      disease-free survival and overall survival of patients. The investigators believe that this
      project will facilitate the establishment of domestic nutrition and lifestyle data of gastric
      cancer of China, and the improvement of the quality of clinical management of patients with
      gastric cancer.
Background - Gastric cancer incidence is increasing at an alarming rate in China. Recent
      studies reported that nutrition status and lifestyle factors such as dietary pattern,
      obesity, physical activity, depression, diabetes, aspirin use and vitamin supplement were
      associated cancer risk. Yet, the influence of nutrition and lifestyle factors on gastric
      cancer outcome (i.e. recurrence and survival) in gastric cancer survivors is largely unknown.
      And there is currently no large cohort studies investigated the impact of these factors on
      gastric cancer outcomes in China.

      Objectives - Our study aims to evaluate the impact of nutrition status and lifestyle factors
      such as dietary pattern, tea consumption, obesity, physical activity, depression, diabetes,
      aspirin use and vitamin supplement on gastric cancer outcome (disease-specific survival,
      disease-free survival and overall survival).

      Settings and methods - The study will recruit approximately 50,000 participants with gastric
      cancer from 12 public hospitals in China after informed consent. Appropriate questionnaires
      will be utilized to evaluate nutrition status and lifestyle factors such as dietary pattern,
      tea consumption, obesity, physical activity, depression, diabetes, aspirin use and vitamin
      supplement. The association of disease-specific survival, disease-free survival and overall
      survival with these factors will be evaluated.

      Impact - To the best of our knowledge, this is the first large cohort, systematically
      investigation of the impact of nutrition status and lifestyle factors on gastric cancer
      outcome. When complete, our investigation would supply a systematical and precise
      understanding of the impact nutrition status and lifestyle factors on cancer out come in
      China.
observational model: Cohort
time perspective: Prospective
measure: Disease-specific survival
time frame: 7 years
description: Disease-specific survival is defined as the time elapsed from surgery to death due to gastric cancer. Concretely, the cause of death obtained in the follow up was classified according to ICD-10 conventions. Disease-specific deaths included those with an underlying cause attributed to ICD-10 codes C18.0-C20.0 or C26.0.
measure: Overall survival
time frame: 7 years
description: Overall survival is defined as the time elapsed from surgery to the date of death from any cause
measure: Disease-free survival
time frame: 7 years
description: Disease-free survival is defined as the time elapsed from surgery to the first occurrence of any of the following events: recurrence of gastric cancer; gastric cancer distant metastasis; development of second non-colorectal malignancy excluding basal cell carcinomas of the skin and carcinoma in situ of the cervix; or death from any cause without documentation of a cancer-related event.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Dake Chu, M.D.
email: chudake@hotmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: State Key Laboratory of Cancer Biology
investigator full name: Dake Chu
investigator title: Dr.
mesh term: Stomach Neoplasms