xml: <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/NCT06028516</url>
    </required_header>
    <id_info>
      <org_study_id>Manfei01</org_study_id>
      <nct_id>NCT06028516</nct_id>
    </id_info>
    <brief_title>MRD Application in Colorectal Cancer Patients</brief_title>
    <official_title>ctDNA Monitoring Cancer Recurrence and Its Clinical Value in Solid Tumor</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shandong First Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Jinan Central Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Shandong First Medical 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>
        We first collect tumor tissue and adjacent tissue to peform the WES sequencing, then collect&#xD;
        blood after postoperative surgery 1, 3. 6, 9, 12, 18, 24 month to detect ctDNA.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        ctDNA is obtained from plasma rather than serum, as the latter contains more DNA released&#xD;
        from immune cells during clotting. Blood should be drawn into a K2EDTA or cell stabilization&#xD;
        tube (e.g., Streck cfDNA collection tube). Plasma isolation should be performed as soon as&#xD;
        possible, no later than 24 hours, using K2EDTA (preferably within 4-6 hours) and, if using&#xD;
        cell stabilization tubes, within 2-7 days, temporarily stored at 4°C.&#xD;
  &#xD;
        Sample disposal procedure: collect whole anticoagulated blood, gently invert to fully&#xD;
        anticoagulate, plasma fractionation should be performed as soon as possible, no later than 24&#xD;
        hours, temporarily stored at 4°C using K2EDTA (preferably within 4-6 hours), and stored at&#xD;
        -80°C for long term. The collected anticoagulant blood is placed in an ice box containing ice&#xD;
        packs and transported vertically to a centrifugable laboratory. Centrifuge at 3000 rpm at 4°C&#xD;
        for 15 min, take the upper layer, and aliquot 0.5 mL/tube into 1.5 mL centrifuge tubes.&#xD;
        Cryopreserved at -80 °C, 1 mL of whole blood yields approximately 0.5 mL of plasma.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 6, 2021</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>ctDNA positive patients are detedcted before PET-CT</measure>
      <time_frame>2023.12.31</time_frame>
      <description>multiple PCR based on the WES results</description>
    </primary_outcome>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Colorectal Cancer</condition>
    <condition>Surgery</condition>
    <condition>Chemotherapy Effect</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with colorectal cancer and they were received routine laparoscopic surgery and&#xD;
          regular chemotherapy.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          (1) Patients with colorectal tumors, whose clinical symptoms meet the diagnostic criteria&#xD;
          of colon cancer in my country, and pathologically diagnosed as colorectal cancer after&#xD;
          surgery; (2) patients with stage II-III colorectal cancer; (3) aged 30-80 years; (4) All&#xD;
          underwent conventional radiotherapy and chemotherapy after operation; (5) Complete clinical&#xD;
          data and follow-up records were available.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  (1) Other serious diseases (cardiovascular and cerebrovascular diseases, kidney&#xD;
               diseases, etc.) before operation; (2) Combined with multiple primary colorectal&#xD;
               cancers; (3) Patients with other malignant tumors within the past 5 years; (4)&#xD;
               Combined with digestive tract Obstruction, perforation, bleeding and other indications&#xD;
               for emergency surgery.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Tao Xu, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Shandong First Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Manfei Liang, PhD</last_name>
      <phone>0531-59556161</phone>
      <email>manfeiliang@sina.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Jinan central hospital affiliated to Shandong First Medical University</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <zip>250017</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Manfei Liang, PhD</last_name>
        <phone>0531-59556161</phone>
        <email>manfeiliang@sina.com</email>
      </contact>
      <contact_backup>
        <last_name>Guoqin Liu</last_name>
      </contact_backup>
      <investigator>
        <last_name>Manfei Liang, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Zhou J, Wang C, Lin G, Xiao Y, Jia W, Xiao G, Liu Q, Wu B, Wu A, Qiu H, Zhang F, Hu K, Xue H, Shen Z, Wang Z, Han J, Niu B, Xu Y, Yu Z, Yang L. Serial Circulating Tumor DNA in Predicting and Monitoring the Effect of Neoadjuvant Chemoradiotherapy in Patients with Rectal Cancer: A Prospective Multicenter Study. Clin Cancer Res. 2021 Jan 1;27(1):301-310. doi: 10.1158/1078-0432.CCR-20-2299. Epub 2020 Oct 12.</citation>
      <PMID>33046514</PMID>
    </reference>
    <results_reference>
      <citation>Chen G, Peng J, Xiao Q, Wu HX, Wu X, Wang F, Li L, Ding P, Zhao Q, Li Y, Wang D, Shao Y, Bao H, Pan Z, Ding KF, Cai S, Wang F, Xu RH. Postoperative circulating tumor DNA as markers of recurrence risk in stages II to III colorectal cancer. J Hematol Oncol. 2021 May 17;14(1):80. doi: 10.1186/s13045-021-01089-z.</citation>
      <PMID>34001194</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colorectal Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>It will be available when our paper is accepted.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06028516
  org study id: Manfei01
  nct id: NCT06028516
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  We first collect tumor tissue and adjacent tissue to peform the WES sequencing, then collect
        blood after postoperative surgery 1, 3. 6, 9, 12, 18, 24 month to detect ctDNA.
  ctDNA is obtained from plasma rather than serum, as the latter contains more DNA released
        from immune cells during clotting. Blood should be drawn into a K2EDTA or cell stabilization
        tube (e.g., Streck cfDNA collection tube). Plasma isolation should be performed as soon as
        possible, no later than 24 hours, using K2EDTA (preferably within 4-6 hours) and, if using
        cell stabilization tubes, within 2-7 days, temporarily stored at 4°C.
  
        Sample disposal procedure: collect whole anticoagulated blood, gently invert to fully
        anticoagulate, plasma fractionation should be performed as soon as possible, no later than 24
        hours, temporarily stored at 4°C using K2EDTA (preferably within 4-6 hours), and stored at
        -80°C for long term. The collected anticoagulant blood is placed in an ice box containing ice
        packs and transported vertically to a centrifugable laboratory. Centrifuge at 3000 rpm at 4°C
        for 15 min, take the upper layer, and aliquot 0.5 mL/tube into 1.5 mL centrifuge tubes.
        Cryopreserved at -80 °C, 1 mL of whole blood yields approximately 0.5 mL of plasma.
  observational model: Cohort
  time perspective: Prospective
  measure: ctDNA positive patients are detedcted before PET-CT
  time frame: 2023.12.31
  description: multiple PCR based on the WES results
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: 80 Years
  last name: Tao Xu, PhD
  role: Study Director
  affiliation: Shandong First Medical University
  last name: Manfei Liang, PhD
  phone: 0531-59556161
  email: manfeiliang@sina.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: China
  citation: Zhou J, Wang C, Lin G, Xiao Y, Jia W, Xiao G, Liu Q, Wu B, Wu A, Qiu H, Zhang F, Hu K, Xue H, Shen Z, Wang Z, Han J, Niu B, Xu Y, Yu Z, Yang L. Serial Circulating Tumor DNA in Predicting and Monitoring the Effect of Neoadjuvant Chemoradiotherapy in Patients with Rectal Cancer: A Prospective Multicenter Study. Clin Cancer Res. 2021 Jan 1;27(1):301-310. doi: 10.1158/1078-0432.CCR-20-2299. Epub 2020 Oct 12.
  PMID: 33046514
  citation: Chen G, Peng J, Xiao Q, Wu HX, Wu X, Wang F, Li L, Ding P, Zhao Q, Li Y, Wang D, Shao Y, Bao H, Pan Z, Ding KF, Cai S, Wang F, Xu RH. Postoperative circulating tumor DNA as markers of recurrence risk in stages II to III colorectal cancer. J Hematol Oncol. 2021 May 17;14(1):80. doi: 10.1186/s13045-021-01089-z.
  PMID: 34001194
  responsible party type: Sponsor
  mesh term: Colorectal Neoplasms
  sharing ipd: No
  ipd description: It will be available when our paper is accepted.