<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/NCT02997241</url>
  </required_header>
  <id_info>
    <org_study_id>MG-WXu</org_study_id>
    <nct_id>NCT02997241</nct_id>
  </id_info>
  <brief_title>Colon Cancer Treatment Decisions and Recurrence Predicting</brief_title>
  <acronym>CCTDRP</acronym>
  <official_title>Circulating Tumor DNA Predict Recurrence and Aid Treatment Decisions in Colon Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MyGenostics Inc., Beijing</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>MyGenostics Inc., Beijing</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to determine the relationship between change of gene copies and&#xD;
      recurrence，and the overall survival at 5 years after chemotherapy based on clinical prognosis&#xD;
      compared to Oncocare detection prognosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Colorectal cancer is the third most common cancer worldwide. About two-thirds of the patients&#xD;
      have a good therapeutic effect by combining surgical adjuvant treatment. But there are still&#xD;
      30-40% of patients may relapse. Efficient relapse early surveillance and accurate treatment&#xD;
      decisions can avoid excessive medical treatment，and keep timely intervention to tumor&#xD;
      recurrence as well. That's very important to extend the survival of patients. Currently, the&#xD;
      efficient surveillance tools recommended by surveillance guidelines include clinical&#xD;
      assessment, serum carcinoembryonic antigen testing, colonoscopy and CT.&#xD;
&#xD;
      Cell-free DNA(cfDNA)，the free form of DNA in the plasma，derived from the normal cells, the&#xD;
      abnormal cells (such as tumor cells) or external (such as viral DNA). The plasma cell-free&#xD;
      DNA derived from tumor cells is the circulating tumour DNA(ctDNA).&#xD;
&#xD;
      As most solid tumors, including CRC, release ctDNA into the blood,precision medical&#xD;
      applications of ctDNA liquid biopsy in colorectal cancer to predict recurrence and aid&#xD;
      treatment decisions has become a hot topic.&#xD;
&#xD;
      Recent research shows that substantially all of colorectal cancer patients have somatic&#xD;
      genetic alterations, including both single-base mutation and larger somatic structural&#xD;
      variations (SSVs). Mutations in these genes can be used as biomarkers to evaluate tumor&#xD;
      burden, predict recurrence and supply information for treatment decisions through monitor and&#xD;
      quantify ctDNA.&#xD;
&#xD;
      In this program，sequencing the tissue from colorectal cancer patients by capture technology&#xD;
      TM and next generation sequencing(NGS),the specific somatic mutations，the so-called&#xD;
      biomarkers, can be found.The analysis results of sequencing can help to the study of tumor&#xD;
      molecular pathology and supply information for targetable drug.The continuous monitoring of&#xD;
      biomarkers in the plasma can predict recurrence and supply information for treatment&#xD;
      decisions.&#xD;
&#xD;
      In phase I trials， recruit 200 volunteers with colorectal cancer will be recruited.the&#xD;
      investigators will test the recurrence predicting project through OncocareTM(method mentioned&#xD;
      above). In phase Ⅱ trials，the colorectal cancer patients will be categorized into four groups&#xD;
      on the basis of genetic risk judged by OncocareTM and clinical risk judged by Clinical&#xD;
      routine method. Particular emphasis is on the group of low genetic risk but high clinical&#xD;
      risk and the group of high genetic risk but low clinical risk.&#xD;
&#xD;
      The purpose of the study is to determine the relationship between change of gene copies and&#xD;
      recurrence，and the overall survival at 5 years after chemotherapy based on clinical prognosis&#xD;
      compared to Oncocare detection prognosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">September 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>patients treated with chemotherapy based on clinical prognosis compared to Oncocare detection prognosis</measure>
    <time_frame>From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 66 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>the rate of gene copies change from primary detection to recurrence</measure>
    <time_frame>From date of randomization until the date of first documented progression, assessed up to 100 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival at 5 years</measure>
    <time_frame>From date of randomization until the date of death from any cause, assessed up to 60 months</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Colonic Neoplasms</condition>
  <arm_group>
    <arm_group_label>high genetic risk and high clinical risk</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>on the basis of genetic risk judged by Oncocare and clinical risk judged by Clinical routine method</description>
  </arm_group>
  <arm_group>
    <arm_group_label>low genetic risk but high clinical risk</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>on the basis of genetic risk judged by Oncocare and clinical risk judged by Clinical routine method，randomized design，and chemotherapy for colorectal carcinoma</description>
  </arm_group>
  <arm_group>
    <arm_group_label>high genetic risk but low clinical risk</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>on the basis of genetic risk judged by Oncocare and clinical risk judged by Clinical routine method</description>
  </arm_group>
  <arm_group>
    <arm_group_label>low genetic risk and low clinical risk</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>on the basis of genetic risk judged by Oncocare and clinical risk judged by Clinical routine method</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>OncoCare</intervention_name>
    <description>Personalized monitoring</description>
    <arm_group_label>high genetic risk and high clinical risk</arm_group_label>
    <arm_group_label>high genetic risk but low clinical risk</arm_group_label>
    <arm_group_label>low genetic risk and low clinical risk</arm_group_label>
    <arm_group_label>low genetic risk but high clinical risk</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>chemotherapy for colorectal carcinoma</intervention_name>
    <description>chemotherapy for colorectal carcinoma</description>
    <arm_group_label>high genetic risk but low clinical risk</arm_group_label>
    <arm_group_label>low genetic risk but high clinical risk</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  more than eighteen, diagnosed with colorectal cancer， not chemotherapy history, Inform&#xD;
             consent signed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychosocial disorder, No inform consent signed.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wentong Xu, A.P.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese PLA General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wentong Xu, A.P.</last_name>
    <phone>13911779137</phone>
    <email>xuwentong@medmail.com.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100853</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Wentong Xu, A.P.</last_name>
      <phone>13911779137</phone>
      <email>xuwentong@medmail.com.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>December 15, 2016</last_update_submitted>
  <last_update_submitted_qc>December 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Colonic Neoplasms</keyword>
  <keyword>recurrence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic Neoplasms</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02997241
org study id: MG-WXu
nct id: NCT02997241
lead sponsor: 
collaborator: 
has dmc: No
The purpose of the study is to determine the relationship between change of gene copies and
      recurrence，and the overall survival at 5 years after chemotherapy based on clinical prognosis
      compared to Oncocare detection prognosis.
Colorectal cancer is the third most common cancer worldwide. About two-thirds of the patients
      have a good therapeutic effect by combining surgical adjuvant treatment. But there are still
      30-40% of patients may relapse. Efficient relapse early surveillance and accurate treatment
      decisions can avoid excessive medical treatment，and keep timely intervention to tumor
      recurrence as well. That's very important to extend the survival of patients. Currently, the
      efficient surveillance tools recommended by surveillance guidelines include clinical
      assessment, serum carcinoembryonic antigen testing, colonoscopy and CT.

      Cell-free DNA(cfDNA)，the free form of DNA in the plasma，derived from the normal cells, the
      abnormal cells (such as tumor cells) or external (such as viral DNA). The plasma cell-free
      DNA derived from tumor cells is the circulating tumour DNA(ctDNA).

      As most solid tumors, including CRC, release ctDNA into the blood,precision medical
      applications of ctDNA liquid biopsy in colorectal cancer to predict recurrence and aid
      treatment decisions has become a hot topic.

      Recent research shows that substantially all of colorectal cancer patients have somatic
      genetic alterations, including both single-base mutation and larger somatic structural
      variations (SSVs). Mutations in these genes can be used as biomarkers to evaluate tumor
      burden, predict recurrence and supply information for treatment decisions through monitor and
      quantify ctDNA.

      In this program，sequencing the tissue from colorectal cancer patients by capture technology
      TM and next generation sequencing(NGS),the specific somatic mutations，the so-called
      biomarkers, can be found.The analysis results of sequencing can help to the study of tumor
      molecular pathology and supply information for targetable drug.The continuous monitoring of
      biomarkers in the plasma can predict recurrence and supply information for treatment
      decisions.

      In phase I trials， recruit 200 volunteers with colorectal cancer will be recruited.the
      investigators will test the recurrence predicting project through OncocareTM(method mentioned
      above). In phase Ⅱ trials，the colorectal cancer patients will be categorized into four groups
      on the basis of genetic risk judged by OncocareTM and clinical risk judged by Clinical
      routine method. Particular emphasis is on the group of low genetic risk but high clinical
      risk and the group of high genetic risk but low clinical risk.

      The purpose of the study is to determine the relationship between change of gene copies and
      recurrence，and the overall survival at 5 years after chemotherapy based on clinical prognosis
      compared to Oncocare detection prognosis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: patients treated with chemotherapy based on clinical prognosis compared to Oncocare detection prognosis
time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 66 weeks
measure: the rate of gene copies change from primary detection to recurrence
time frame: From date of randomization until the date of first documented progression, assessed up to 100 weeks
measure: Overall survival at 5 years
time frame: From date of randomization until the date of death from any cause, assessed up to 60 months
arm group label: high genetic risk and high clinical risk
arm group type: Other
description: on the basis of genetic risk judged by Oncocare and clinical risk judged by Clinical routine method
arm group label: low genetic risk but high clinical risk
arm group type: Active Comparator
description: on the basis of genetic risk judged by Oncocare and clinical risk judged by Clinical routine method，randomized design，and chemotherapy for colorectal carcinoma
arm group label: high genetic risk but low clinical risk
arm group type: Active Comparator
description: on the basis of genetic risk judged by Oncocare and clinical risk judged by Clinical routine method
arm group label: low genetic risk and low clinical risk
arm group type: Other
description: on the basis of genetic risk judged by Oncocare and clinical risk judged by Clinical routine method
intervention type: Biological
intervention name: OncoCare
description: Personalized monitoring
arm group label: high genetic risk and high clinical risk
arm group label: high genetic risk but low clinical risk
arm group label: low genetic risk and low clinical risk
arm group label: low genetic risk but high clinical risk
intervention type: Drug
intervention name: chemotherapy for colorectal carcinoma
description: chemotherapy for colorectal carcinoma
arm group label: high genetic risk but low clinical risk
arm group label: low genetic risk but high clinical risk
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wentong Xu, A.P.
role: Principal Investigator
affiliation: Chinese PLA General Hospital
last name: Wentong Xu, A.P.
phone: 13911779137
email: xuwentong@medmail.com.cn
facility: 
contact: 
country: China
responsible party type: Sponsor
mesh term: Colonic Neoplasms
mesh term: Recurrence
sharing ipd: No