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/NCT05969938</url>
    </required_header>
    <id_info>
      <org_study_id>B2023-239-01</org_study_id>
      <nct_id>NCT05969938</nct_id>
    </id_info>
    <brief_title>Predicting the Efficacy and Prognosis of Rectal Cancer Patients Based on ctDNA-MRD Technology</brief_title>
    <official_title>Predicting the Efficacy and Prognosis of Rectal Cancer Patients Receiving Neoadjuvant Chemoradiotherapy Based on Circulating Tumor DNA-minimal Residual Disease Technology : A Prospective, Observational Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>WeiWei Xiao</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Haplox Biotechnology Co., Ltd.</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Sun Yat-sen University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to study the performance of MRD monitoring in predicting the&#xD;
        efficacy and prognosis of neoadjuvant therapy in patients with rectal cancer, and to explore&#xD;
        the value of MRD detection in evaluating the prognosis of patients. In this prospective&#xD;
        study, 50 patients with stage II-III rectal cancer who are planing to receive neoadjuvant&#xD;
        chemoradiotherapy will be enrolled. The tumor tissue will be collected by colonoscopy before&#xD;
        treatment and blood samples will be collected before treatment and during treatment.The whole&#xD;
        blood samples will receive MRD detection. The change rate and clearance rate of MRD during&#xD;
        treatment will be calculated, and will be associated with imaging efficacy evaluation,&#xD;
        pathological efficacy evaluation,and prognosis, to determine the performance of MRD in&#xD;
        predicting and judging the efficacy of neoadjuvant chemoradiotherapy and postoperative&#xD;
        recurrence of rectal cancer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a prospective, observational study. It is expected to enroll 50 patients with&#xD;
        newly diagnosed stage II-III rectal cancer.Before neoadjuvant chemoradiotherapy, tumor tissue&#xD;
        will be collected by colonoscopy biopsy for WES and customized panel design, and peripheral&#xD;
        blood samples will be collected for baseline MRD detection ( MRD1 ) and during neoadjuvant&#xD;
        concurrent chemoradiotherapy ( MRD2-6 ) .Peripheral blood sample will be collected 3-4 weeks&#xD;
        after radical surgery ( MRD7 ). For patients who achieved cCR after the end of neoadjuvant&#xD;
        therapy and adopted the W &amp; W ( watch and wait ) strategy, the sampling time point was 3&#xD;
        months after the start of watching and waiting ( MRD7 ).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 21, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</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>Area under the ROC curve (AUC) of the MRD biomarker</measure>
      <time_frame>Baseline to 12 months</time_frame>
      <description>The area under the ROC curve ( AUC ) of MRD</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Local recurrence-free survival（LRFS）</measure>
      <time_frame>From date of radical surgery to local recurrence or death due to disease progression，assessed up to 60 months.</time_frame>
      <description>LRFS differences in patients with MRD clearance / decrease / increase</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Distant metastases-free survival（DMFS）</measure>
      <time_frame>From date of the beginning of neoadjuvant chemoradiotherapy to disease metastasis or death due to any cause,assessed up to 60 months.</time_frame>
      <description>DMFS differences in patients with MRD clearance / decrease / increase</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Rectal Adenocarcinoma</condition>
    <condition>Circulating Tumor DNA</condition>
    <condition>Minimal Residual Disease</condition>
    <condition>Neoadjuvant Chemoradiotherapy</condition>
    <arm_group>
      <arm_group_label>Treatment group</arm_group_label>
      <description>A total of 50 patients with stage II-III rectal cancer who plan to receive neoadjuvant chemoradiotherapy between the ages of 18-75 years old, and these patients have no distant metastasis, normal main organ function, and can receive long-term follow-up. simultaneously, these patients are required to provide sufficient ' colonoscopy collection ' tumor tissue samples for MRD customization, and sufficient whole blood samples are required for baseline MRD detection.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>MRD detection</intervention_name>
      <description>Peripheral blood samples were collected for MRD detection before neoadjuvant chemoradiotherapy, during neoadjuvant chemoradiotherapy, and 3-4 weeks after radical surgery. For patients who achieved cCR after neoadjuvant therapy and adopted the W &amp; W strategy, the sampling time point was 3 months after the start of watching and waiting.</description>
      <arm_group_label>Treatment group</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        The samples including two kinds :1.We will collect tumor tissue samples for WES detection and&#xD;
        customized panel.2. We will collect peripheral blood samples for MRD detection.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          This study intends to include 50 patients with stage II-III rectal cancer who plan to&#xD;
          receive neoadjuvant chemoradiotherapy between the ages of 18-75 years old.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 18-75&#xD;
  &#xD;
            2. Rectal adenocarcinoma confirmed by pathology&#xD;
  &#xD;
            3. The clinical stage is II-III.&#xD;
  &#xD;
            4. Neoadjuvant chemoradiotherapy + radical surgery is planned ( cCR patients can choose&#xD;
               to wait for observation ).&#xD;
  &#xD;
            5. ECOG 0-1;&#xD;
  &#xD;
            6. No distant metastasis ;&#xD;
  &#xD;
            7. Main organ function is normal ;&#xD;
  &#xD;
            8. signed informed consent and willing to accept long-term follow-up；&#xD;
  &#xD;
            9. No anti-tumor treatment was received within 4 weeks before baseline sampling ;&#xD;
  &#xD;
           10. Adequate ' colonoscopy ' tumor tissue samples can be provided for MRD customization,&#xD;
               and sufficient whole blood samples need to be provided for baseline MRD detection.&#xD;
  &#xD;
               -&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. unable to provide sufficient tissue / blood samples to meet the research needs ;&#xD;
  &#xD;
            2. received radiotherapy, chemotherapy, or other targeted or immunotherapy before&#xD;
               enrollment ;&#xD;
  &#xD;
            3. Patients did not receive neoadjuvant therapy according to the original plan ;&#xD;
  &#xD;
            4. Patients refused to accept genetic testing. -&#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>WeiWei Xiao</last_name>
      <phone>8613710390520</phone>
      <phone_ext>8613710390520</phone_ext>
      <email>xiaoww@sysucc.org.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>WeiWei Xiao</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510060</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>WeiWei Xiao</last_name>
        <phone>+8613710390520</phone>
        <email>xiaoww@sysucc.org.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Yang Y, Xu H, Chen G, Pan Y. Stratified Prognostic Value of Pathological Response to Preoperative Treatment in yp II/III Rectal Cancer. Front Oncol. 2021 Dec 16;11:795137. doi: 10.3389/fonc.2021.795137. eCollection 2021.</citation>
      <PMID>34976836</PMID>
    </reference>
    <reference>
      <citation>Scholer LV, Reinert T, Orntoft MW, Kassentoft CG, Arnadottir SS, Vang S, Nordentoft I, Knudsen M, Lamy P, Andreasen D, Mortensen FV, Knudsen AR, Stribolt K, Sivesgaard K, Mouritzen P, Nielsen HJ, Laurberg S, Orntoft TF, Andersen CL. Clinical Implications of Monitoring Circulating Tumor DNA in Patients with Colorectal Cancer. Clin Cancer Res. 2017 Sep 15;23(18):5437-5445. doi: 10.1158/1078-0432.CCR-17-0510. Epub 2017 Jun 9.</citation>
      <PMID>28600478</PMID>
    </reference>
    <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>
    <reference>
      <citation>Pazdirek F, Minarik M, Benesova L, Halkova T, Belsanova B, Macek M, Stepanek L, Hoch J. Monitoring of Early Changes of Circulating Tumor DNA in the Plasma of Rectal Cancer Patients Receiving Neoadjuvant Concomitant Chemoradiotherapy: Evaluation for Prognosis and Prediction of Therapeutic Response. Front Oncol. 2020 Jul 24;10:1028. doi: 10.3389/fonc.2020.01028. eCollection 2020.</citation>
      <PMID>32793464</PMID>
    </reference>
    <reference>
      <citation>Wang Y, Yang L, Bao H, Fan X, Xia F, Wan J, Shen L, Guan Y, Bao H, Wu X, Xu Y, Shao Y, Sun Y, Tong T, Li X, Xu Y, Cai S, Zhu J, Zhang Z. Utility of ctDNA in predicting response to neoadjuvant chemoradiotherapy and prognosis assessment in locally advanced rectal cancer: A prospective cohort study. PLoS Med. 2021 Aug 31;18(8):e1003741. doi: 10.1371/journal.pmed.1003741. eCollection 2021 Aug.</citation>
      <PMID>34464382</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
      <investigator_full_name>WeiWei Xiao</investigator_full_name>
      <investigator_title>Sun Yat-sen University</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasm, Residual</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </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/NCT05969938
  org study id: B2023-239-01
  nct id: NCT05969938
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to study the performance of MRD monitoring in predicting the
        efficacy and prognosis of neoadjuvant therapy in patients with rectal cancer, and to explore
        the value of MRD detection in evaluating the prognosis of patients. In this prospective
        study, 50 patients with stage II-III rectal cancer who are planing to receive neoadjuvant
        chemoradiotherapy will be enrolled. The tumor tissue will be collected by colonoscopy before
        treatment and blood samples will be collected before treatment and during treatment.The whole
        blood samples will receive MRD detection. The change rate and clearance rate of MRD during
        treatment will be calculated, and will be associated with imaging efficacy evaluation,
        pathological efficacy evaluation,and prognosis, to determine the performance of MRD in
        predicting and judging the efficacy of neoadjuvant chemoradiotherapy and postoperative
        recurrence of rectal cancer.
  This study is a prospective, observational study. It is expected to enroll 50 patients with
        newly diagnosed stage II-III rectal cancer.Before neoadjuvant chemoradiotherapy, tumor tissue
        will be collected by colonoscopy biopsy for WES and customized panel design, and peripheral
        blood samples will be collected for baseline MRD detection ( MRD1 ) and during neoadjuvant
        concurrent chemoradiotherapy ( MRD2-6 ) .Peripheral blood sample will be collected 3-4 weeks
        after radical surgery ( MRD7 ). For patients who achieved cCR after the end of neoadjuvant
        therapy and adopted the W & W ( watch and wait ) strategy, the sampling time point was 3
        months after the start of watching and waiting ( MRD7 ).
  observational model: Cohort
  time perspective: Prospective
  measure: Area under the ROC curve (AUC) of the MRD biomarker
  time frame: Baseline to 12 months
  description: The area under the ROC curve ( AUC ) of MRD
  measure: Local recurrence-free survival（LRFS）
  time frame: From date of radical surgery to local recurrence or death due to disease progression，assessed up to 60 months.
  description: LRFS differences in patients with MRD clearance / decrease / increase
  measure: Distant metastases-free survival（DMFS）
  time frame: From date of the beginning of neoadjuvant chemoradiotherapy to disease metastasis or death due to any cause,assessed up to 60 months.
  description: DMFS differences in patients with MRD clearance / decrease / increase
  arm group label: Treatment group
  description: A total of 50 patients with stage II-III rectal cancer who plan to receive neoadjuvant chemoradiotherapy between the ages of 18-75 years old, and these patients have no distant metastasis, normal main organ function, and can receive long-term follow-up. simultaneously, these patients are required to provide sufficient ' colonoscopy collection ' tumor tissue samples for MRD customization, and sufficient whole blood samples are required for baseline MRD detection.
  intervention type: Diagnostic Test
  intervention name: MRD detection
  description: Peripheral blood samples were collected for MRD detection before neoadjuvant chemoradiotherapy, during neoadjuvant chemoradiotherapy, and 3-4 weeks after radical surgery. For patients who achieved cCR after neoadjuvant therapy and adopted the W & W strategy, the sampling time point was 3 months after the start of watching and waiting.
  arm group label: Treatment group
  The samples including two kinds :1.We will collect tumor tissue samples for WES detection and
        customized panel.2. We will collect peripheral blood samples for MRD detection.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: WeiWei Xiao
  phone: 8613710390520
  phone ext: 8613710390520
  email: xiaoww@sysucc.org.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  citation: Yang Y, Xu H, Chen G, Pan Y. Stratified Prognostic Value of Pathological Response to Preoperative Treatment in yp II/III Rectal Cancer. Front Oncol. 2021 Dec 16;11:795137. doi: 10.3389/fonc.2021.795137. eCollection 2021.
  PMID: 34976836
  citation: Scholer LV, Reinert T, Orntoft MW, Kassentoft CG, Arnadottir SS, Vang S, Nordentoft I, Knudsen M, Lamy P, Andreasen D, Mortensen FV, Knudsen AR, Stribolt K, Sivesgaard K, Mouritzen P, Nielsen HJ, Laurberg S, Orntoft TF, Andersen CL. Clinical Implications of Monitoring Circulating Tumor DNA in Patients with Colorectal Cancer. Clin Cancer Res. 2017 Sep 15;23(18):5437-5445. doi: 10.1158/1078-0432.CCR-17-0510. Epub 2017 Jun 9.
  PMID: 28600478
  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: Pazdirek F, Minarik M, Benesova L, Halkova T, Belsanova B, Macek M, Stepanek L, Hoch J. Monitoring of Early Changes of Circulating Tumor DNA in the Plasma of Rectal Cancer Patients Receiving Neoadjuvant Concomitant Chemoradiotherapy: Evaluation for Prognosis and Prediction of Therapeutic Response. Front Oncol. 2020 Jul 24;10:1028. doi: 10.3389/fonc.2020.01028. eCollection 2020.
  PMID: 32793464
  citation: Wang Y, Yang L, Bao H, Fan X, Xia F, Wan J, Shen L, Guan Y, Bao H, Wu X, Xu Y, Shao Y, Sun Y, Tong T, Li X, Xu Y, Cai S, Zhu J, Zhang Z. Utility of ctDNA in predicting response to neoadjuvant chemoradiotherapy and prognosis assessment in locally advanced rectal cancer: A prospective cohort study. PLoS Med. 2021 Aug 31;18(8):e1003741. doi: 10.1371/journal.pmed.1003741. eCollection 2021 Aug.
  PMID: 34464382
  responsible party type: Sponsor-Investigator
  investigator affiliation: Sun Yat-sen University
  investigator full name: WeiWei Xiao
  investigator title: Sun Yat-sen University
  mesh term: Neoplasm, Residual
  sharing ipd: Undecided