<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/NCT02222753</url>
  </required_header>
  <id_info>
    <org_study_id>2014AA020801</org_study_id>
    <nct_id>NCT02222753</nct_id>
  </id_info>
  <brief_title>Immunological Markers Screening for Colorectal Cancer</brief_title>
  <official_title>Therapeutic Effect and Prognosis Predication Related Immunocyte Subgroup and Immunologic Factors Screeing for Colorectal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>State Key Laboratory of Cancer Biology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Air Force Military Medical University, China</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>
  </sponsors>
  <source>State Key Laboratory of Cancer Biology</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Colorectal cancer incidence is increasing at an alarming rate in China. Recent reports&#xD;
      concluded aberrant immunological function was associated with colorectal cancer outcome,&#xD;
      however, the influence of immunocyte subgroup and immunologic factors on cancer outcome in&#xD;
      colorectal cancer survivors is largely unknown.The investigators will explore the impact of&#xD;
      immunocyte subgroup and immunologic factors on colorectal cancer disease-specific,&#xD;
      disease-free and overall survival. The investigators will recruit approximately 5,000&#xD;
      patients as a prospective study cohort. During follow up, the investigators will explore the&#xD;
      association of these factors with outcome of patients. The investigators believe that this&#xD;
      project will improve the understanding of the impact of immunocyte subgroup and immunologic&#xD;
      factors on colorectal cancer outcome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2014</start_date>
  <primary_completion_date type="Anticipated">December 2018</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>5 years</time_frame>
    <description>Disease-specific survival is defined as the time elapsed from surgery to death due to CRC. 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>5 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>5 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 colorectal cancer; colorectal 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">5000</enrollment>
  <condition>Colorectal Cancer</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Tissue and blood specimens&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        primary care clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patient must have a histologically proven adenocarcinoma of colon or rectum 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;
          -  Gilbert's disease.&#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_official>
    <last_name>Long Cui, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Shanghai Jiao Tong University School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Long Cui, M.D.</last_name>
    <email>longcuidr@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shanghai Jiaotong University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200240</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Long Cui, M.D.</last_name>
      <email>longcuidr@126.com</email>
    </contact>
    <investigator>
      <last_name>Long Cui, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>August 20, 2014</last_update_submitted>
  <last_update_submitted_qc>August 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 21, 2014</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>Colorectal 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/NCT02222753
org study id: 2014AA020801
nct id: NCT02222753
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Colorectal cancer incidence is increasing at an alarming rate in China. Recent reports
      concluded aberrant immunological function was associated with colorectal cancer outcome,
      however, the influence of immunocyte subgroup and immunologic factors on cancer outcome in
      colorectal cancer survivors is largely unknown.The investigators will explore the impact of
      immunocyte subgroup and immunologic factors on colorectal cancer disease-specific,
      disease-free and overall survival. The investigators will recruit approximately 5,000
      patients as a prospective study cohort. During follow up, the investigators will explore the
      association of these factors with outcome of patients. The investigators believe that this
      project will improve the understanding of the impact of immunocyte subgroup and immunologic
      factors on colorectal cancer outcome.
observational model: Cohort
time perspective: Prospective
measure: Disease-specific survival
time frame: 5 years
description: Disease-specific survival is defined as the time elapsed from surgery to death due to CRC. 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: 5 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: 5 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 colorectal cancer; colorectal 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.
Tissue and blood specimens
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Long Cui, M.D.
role: Study Chair
affiliation: Shanghai Jiao Tong University School of Medicine
last name: Long Cui, M.D.
email: longcuidr@126.com
facility: 
status: Recruiting
contact: 
investigator: 
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: Colorectal Neoplasms