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/NCT05978349</url>
    </required_header>
    <id_info>
      <org_study_id>2022-PUMCH-B-005</org_study_id>
      <nct_id>NCT05978349</nct_id>
    </id_info>
    <brief_title>PTC Drug Sensitivity Detection to Guide Postoperative Adjuvant of Colorectal Cancer</brief_title>
    <official_title>Vitro 3D Drug Sensitivity Detection of Micro Tumor (PTC) to Guide Postoperative Adjuvant Treatment Strategy and Prognosis Judgment of Colorectal Cancer--Prospective Clinical Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking Union Medical College Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking Union Medical College Hospital</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>
        The research objectives is to compare vitro 3D drug sensitivity test results of micro tumor&#xD;
        (PTC) with the clinical outcomes of patients, evaluate the consistency between the test&#xD;
        results of the technology platform and the clinical prognosis, and explore the&#xD;
        decision-making value and guiding significance of this technology in assisting the precise&#xD;
        treatment of colorectal cancer. The completion of this study will provide real-world data&#xD;
        support for the clinical application of micro tumor (PTC) in vitro 3D drug sensitivity&#xD;
        detection technology, and provide more valuable reference basis for realizing the&#xD;
        individualization and accuracy of colorectal cancer treatment and improving the clinical&#xD;
        benefit rate.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study is a multi agency prospective cohort study in China. The subjects were patients&#xD;
        aged 18 ~ 75 years with colorectal cancer diagnosed by histopathology or cytology. They must&#xD;
        be colorectal cancer patients who have at least one assessable tumor focus, need adjuvant&#xD;
        therapy after radical surgery, and have not received neoadjuvant therapy， ECoG physical&#xD;
        condition score ≤ 2 points. And they must be voluntarily participate in and sign informed&#xD;
        consent.&#xD;
  &#xD;
        The patients were randomly divided into PTC drug sensitivity test group and control group.&#xD;
        The PTC drug sensitivity test group selected the adjuvant chemotherapy scheme according to&#xD;
        the 3D drug sensitivity test results of micro tumor (PTC) in vitro. The control group made&#xD;
        adjuvant chemotherapy strategy according to clinical experience.&#xD;
  &#xD;
        The primary endpoint was the non inferiority test, and the 3-year disease-free survival rate&#xD;
        was T-C &gt;- Δ&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 14, 2022</start_date>
    <completion_date type="Anticipated">September 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Follow-up and record DFS of patients</measure>
      <time_frame>3 years after enrollment</time_frame>
      <description>We follow-up the patients by outpatient/telephone/online message to find out their survival situation and record their Disease-free-survival time</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Follow-up and record TTP of patients</measure>
      <time_frame>3 years after enrollment</time_frame>
      <description>We follow-up the patients by outpatient/telephone/online message to find out their tumor situation and record their Time To Progress</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Consistency between drug sensitivity results and clinical outcomes</measure>
      <time_frame>3 years after enrollment</time_frame>
      <description>Record the patient's PTC drug sensitivity results and the actual medication therapy, and record the patient's survival status through telephone follow-up, online follow-up and offline diagnosis to compare whether there is correlation between them.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Follow-up and record ORR of patients</measure>
      <time_frame>3 years after enrollment</time_frame>
      <description>We follow-up the patients by outpatient/telephone/online message to find out their tumor situation and record their Objective Response Rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Follow-up and record PFS of patients</measure>
      <time_frame>3 years after enrollment</time_frame>
      <description>We follow-up the patients by outpatient/telephone/online message to find out their tumor situation and record their Progress Free Survival time</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Follow-up and record OS of patients</measure>
      <time_frame>3 years after enrollment</time_frame>
      <description>We follow-up the patients by outpatient/telephone/online message to find out their tumor and survival situation and record their Overall Survival time</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Colo-rectal Cancer</condition>
    <arm_group>
      <arm_group_label>experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Select adjuvant chemotherapy scheme according to 3D drug sensitivity test results of micro tumor (PTC) in vitro</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Formulate adjuvant chemotherapy strategy based on clinical experience</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>adjuvant therapy based on 3D drug sensitivity test results of micro tumor (PTC) in vitro</intervention_name>
      <description>Choose chemotherapeutic drugs（5-fluorouracil + formyltetrahydrofolate/Oxaliplatin + 5-fluorouracil + formyltetrahydrofolate/Irinotecan + 5-fluorouracil + formyltetrahydrofolate/Cetuximab + 5-fluorouracil + formyltetrahydrofolate） based on PTC drug sensitivity results.</description>
      <arm_group_label>experimental group</arm_group_label>
      <other_name>PTC drug sensitivity results</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 18 ~ 75 years old, regardless of gender&#xD;
  &#xD;
            2. Patients with colorectal cancer diagnosed by histopathology or cytology&#xD;
  &#xD;
            3. Colorectal cancer patients who need adjuvant therapy after radical surgery and have&#xD;
               not received neoadjuvant therapy&#xD;
  &#xD;
            4. Having at least one assessable tumor focus&#xD;
  &#xD;
            5. ECoG physical condition score ≤ 2 points&#xD;
  &#xD;
            6. Voluntarily participate and sign informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients diagnosed with metastasis&#xD;
  &#xD;
            2. Patients who cannot obtain tumor samples&#xD;
  &#xD;
            3. Pregnant and lactating women&#xD;
  &#xD;
            4. Patients with poor compliance&#xD;
  &#xD;
            5. Patients with severe cardiovascular and cerebrovascular complications who cannot&#xD;
               receive adjuvant treatment&#xD;
  &#xD;
            6. Patients with other malignant tumors&#xD;
  &#xD;
            7. Suffering from serious mental and nervous system diseases&#xD;
  &#xD;
            8. The researchers believe that patients should not be selected for this study&#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_official>
      <last_name>Guo Lin, Professor</last_name>
      <role>Study Chair</role>
      <affiliation>PUMCH</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jiaolin Zhou, Professor</last_name>
      <phone>13910136704</phone>
      <email>conniezhjl@yahoo.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences</name>
        <address>
          <city>Beijing</city>
          <state>China/Beijing</state>
          <zip>100000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jiaolin Zhou, MD</last_name>
        <phone>13910136704</phone>
        <email>conniezhjl@yahoo.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>colon cancer</keyword>
    <keyword>rectal cancer</keyword>
    <keyword>adjuvant therapy</keyword>
    <keyword>PTC</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Rectal Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT05978349
  org study id: 2022-PUMCH-B-005
  nct id: NCT05978349
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The research objectives is to compare vitro 3D drug sensitivity test results of micro tumor
        (PTC) with the clinical outcomes of patients, evaluate the consistency between the test
        results of the technology platform and the clinical prognosis, and explore the
        decision-making value and guiding significance of this technology in assisting the precise
        treatment of colorectal cancer. The completion of this study will provide real-world data
        support for the clinical application of micro tumor (PTC) in vitro 3D drug sensitivity
        detection technology, and provide more valuable reference basis for realizing the
        individualization and accuracy of colorectal cancer treatment and improving the clinical
        benefit rate.
  The study is a multi agency prospective cohort study in China. The subjects were patients
        aged 18 ~ 75 years with colorectal cancer diagnosed by histopathology or cytology. They must
        be colorectal cancer patients who have at least one assessable tumor focus, need adjuvant
        therapy after radical surgery, and have not received neoadjuvant therapy， ECoG physical
        condition score ≤ 2 points. And they must be voluntarily participate in and sign informed
        consent.
  
        The patients were randomly divided into PTC drug sensitivity test group and control group.
        The PTC drug sensitivity test group selected the adjuvant chemotherapy scheme according to
        the 3D drug sensitivity test results of micro tumor (PTC) in vitro. The control group made
        adjuvant chemotherapy strategy according to clinical experience.
  
        The primary endpoint was the non inferiority test, and the 3-year disease-free survival rate
        was T-C >- Δ
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Follow-up and record DFS of patients
  time frame: 3 years after enrollment
  description: We follow-up the patients by outpatient/telephone/online message to find out their survival situation and record their Disease-free-survival time
  measure: Follow-up and record TTP of patients
  time frame: 3 years after enrollment
  description: We follow-up the patients by outpatient/telephone/online message to find out their tumor situation and record their Time To Progress
  measure: Consistency between drug sensitivity results and clinical outcomes
  time frame: 3 years after enrollment
  description: Record the patient's PTC drug sensitivity results and the actual medication therapy, and record the patient's survival status through telephone follow-up, online follow-up and offline diagnosis to compare whether there is correlation between them.
  measure: Follow-up and record ORR of patients
  time frame: 3 years after enrollment
  description: We follow-up the patients by outpatient/telephone/online message to find out their tumor situation and record their Objective Response Rate
  measure: Follow-up and record PFS of patients
  time frame: 3 years after enrollment
  description: We follow-up the patients by outpatient/telephone/online message to find out their tumor situation and record their Progress Free Survival time
  measure: Follow-up and record OS of patients
  time frame: 3 years after enrollment
  description: We follow-up the patients by outpatient/telephone/online message to find out their tumor and survival situation and record their Overall Survival time
  arm group label: experimental group
  arm group type: Experimental
  description: Select adjuvant chemotherapy scheme according to 3D drug sensitivity test results of micro tumor (PTC) in vitro
  arm group label: control group
  arm group type: No Intervention
  description: Formulate adjuvant chemotherapy strategy based on clinical experience
  intervention type: Drug
  intervention name: adjuvant therapy based on 3D drug sensitivity test results of micro tumor (PTC) in vitro
  description: Choose chemotherapeutic drugs（5-fluorouracil + formyltetrahydrofolate/Oxaliplatin + 5-fluorouracil + formyltetrahydrofolate/Irinotecan + 5-fluorouracil + formyltetrahydrofolate/Cetuximab + 5-fluorouracil + formyltetrahydrofolate） based on PTC drug sensitivity results.
  arm group label: experimental group
  other name: PTC drug sensitivity results
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Guo Lin, Professor
  role: Study Chair
  affiliation: PUMCH
  last name: Jiaolin Zhou, Professor
  phone: 13910136704
  email: conniezhjl@yahoo.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Rectal Neoplasms
  sharing ipd: No