<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/NCT03787667</url>
  </required_header>
  <id_info>
    <org_study_id>ColoRadiomics</org_study_id>
    <nct_id>NCT03787667</nct_id>
  </id_info>
  <brief_title>Application of Radiomics in Precise Preoperative Diagnosis and Prognsis Evaluation of Colorectal Cancer.</brief_title>
  <official_title>Application of Radiomics in Precise Preoperative Diagnosis and Prognsis Evaluation of Colorectal Cancer: a Prospective, Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan University</source>
  <oversight_info>
    <has_dmc>Yes</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 is a prospective, clinical study. This study is to collect and analyze data of radiomics&#xD;
      of primary site or metastasis of colorectal cancer aiming to precisizing preoperative&#xD;
      diagnosis and long-term prognsis evaluation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</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>Sensitivity</measure>
    <time_frame>2 years</time_frame>
    <description>The sensitivity of radiomics in predicting regional or distant synchronous colorectal metastasis</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Colorectal Cancer Stage I-IV</condition>
  <arm_group>
    <arm_group_label>Patients with pathologically diagnosed colorectal cancer</arm_group_label>
    <description>Patients with pathologically diagnosed colorectal cancer</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>CT or MRI based Radiomics</intervention_name>
    <description>Radiomic features were extracted from enhanced CT or MRI of colorectal cancer.</description>
    <arm_group_label>Patients with pathologically diagnosed colorectal cancer</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients received enhaced CT or MRI test must have baseline evaluations performed prior to&#xD;
        the study and must meet all inclusion and exclusion criteria. In addition, the patient must&#xD;
        be thoroughly informed about all aspects of the study, including the study visit schedule&#xD;
        and required evaluations and all regulatory requirements for informed consent.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with pathologically confirmed colorectal cancer&#xD;
&#xD;
          -  Male or female aged 18-75 years old on the day of signing informed consent.&#xD;
&#xD;
          -  Patients who received imageological examination of primary or metastasis&#xD;
&#xD;
          -  Patients who received surgical resection of primary or metastasis&#xD;
&#xD;
          -  Patients must have a performance status of ≤1 on the ECOG Performance Scale.&#xD;
&#xD;
          -  Colorectal cancer is the only malignant tumor&#xD;
&#xD;
          -  Written informed consent must be obtained from patient or patient's legal&#xD;
             representative and ability for patient to comply with the requirements of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients received adjuvant treatment prior to imageological examination&#xD;
&#xD;
          -  Tis stage patients&#xD;
&#xD;
          -  Paitents who diagnosed with malignant disease within 5 years.&#xD;
&#xD;
          -  Patients with a history or current evidence of any condition or abnormality that might&#xD;
             confound the results of the study, interfere with the patient's participation for the&#xD;
             full duration of the study, or is not in the best interest of the patient to&#xD;
             participate, in the opinion of the Investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Guoxiang Cai, M.D.Ph.D.</last_name>
    <phone>+86 13611831623</phone>
    <email>gxcai@fudan.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Fudan University Shanghai Cancer Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guoxiang Cai</last_name>
      <phone>+8613611831623</phone>
      <phone_ext>+8613611831623</phone_ext>
      <email>gxcai@fudan.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 22, 2018</study_first_submitted>
  <study_first_submitted_qc>December 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>December 22, 2018</last_update_submitted>
  <last_update_submitted_qc>December 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Guoxiang Cai</investigator_full_name>
    <investigator_title>Professor</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/NCT03787667
org study id: ColoRadiomics
nct id: NCT03787667
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a prospective, clinical study. This study is to collect and analyze data of radiomics
      of primary site or metastasis of colorectal cancer aiming to precisizing preoperative
      diagnosis and long-term prognsis evaluation.
observational model: Cohort
time perspective: Prospective
measure: Sensitivity
time frame: 2 years
description: The sensitivity of radiomics in predicting regional or distant synchronous colorectal metastasis
arm group label: Patients with pathologically diagnosed colorectal cancer
description: Patients with pathologically diagnosed colorectal cancer
intervention type: Diagnostic Test
intervention name: CT or MRI based Radiomics
description: Radiomic features were extracted from enhanced CT or MRI of colorectal cancer.
arm group label: Patients with pathologically diagnosed colorectal cancer
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Guoxiang Cai, M.D.Ph.D.
phone: +86 13611831623
email: gxcai@fudan.edu.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Guoxiang Cai
investigator title: Professor
mesh term: Colorectal Neoplasms