<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/NCT03252834</url>
  </required_header>
  <id_info>
    <org_study_id>B-ER-106-120</org_study_id>
    <nct_id>NCT03252834</nct_id>
  </id_info>
  <brief_title>Genetic Variants and Chemotherapy-induced Abnormal Thermal Sensation</brief_title>
  <official_title>To Study the Individual Variants of Chemotherapy-induced Abnormal Thermal Sensation in Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cheng-Kung University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cheng-Kung University Hospital</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>
      This is a prospective, single arm, single center study evaluating the use of a 4-gene panel&#xD;
      to predict the occurrence of chemotherapy-induced abnormal thermal threshold in endometrial&#xD;
      and ovarian cancer patients receiving post-operative chemotherapy with&#xD;
      Carboplatin/Paclitaxel, and stage III colorectal cancer patients receiving adjuvant&#xD;
      chemotherapy with mFOLFOX6. A total of 100 patients will be enrolled during 2017 July~ 2019&#xD;
      June. Blood sample will be collected before chemotherapy to analyze the genetic variants of&#xD;
      TRPV1, TRPM2, TRPA1 and ORAI1. All patients will receive neurologic examination (Quantitative&#xD;
      Sensory Test, QST) and complete the questionnaires for quality of life (EQ5D &amp; CIPN20). The&#xD;
      primary endpoint of this study is to test if the genetic variant of TRPV1, TRPM2, TRPA1, and&#xD;
      ORAI1 is a predictive biomarker for the chemotherapy-induced abnormal thermal sensation in&#xD;
      cancer patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Poor enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">December 11, 2020</completion_date>
  <primary_completion_date type="Actual">December 11, 2020</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>The change of thermal pain threshold</measure>
    <time_frame>before chemotherapy &amp; 3, 6, and 9 months after chemotherapy</time_frame>
    <description>The threshold of detecting heat-induced pain</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">12</enrollment>
  <condition>Chemotherapy-induced Abnormal Thermal Sensation</condition>
  <arm_group>
    <arm_group_label>Patients with endometrial or ovarian cancer</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with colorectal cancer</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Genetic variants of TRPV1, TRPM2, TRPA1 and ORAI</intervention_name>
    <description>Genetic variants of TRPV1, TRPM2, TRPA1 and ORAI1 will be analyzed. Quantitative Sensory Test, QST, will be used to determined if there is abnormal thermal sensation.</description>
    <arm_group_label>Patients with colorectal cancer</arm_group_label>
    <arm_group_label>Patients with endometrial or ovarian cancer</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Colorectal, endometrial, or ovarian cancer patients who are scheduled to receive&#xD;
        post-operative adjuvant chemotherapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 20 years old&#xD;
&#xD;
          -  Pathological stage I~IV for ovarian cancer, stage II~IV for endometrial cancer, or&#xD;
             stage III for colorectal cancer.&#xD;
&#xD;
          -  Scheduled to receive adjuvant Paclitaxel/Carboplatin for ovarian or endometrial&#xD;
             cancer, or mFOLFOX6 for colorectal cancer.&#xD;
&#xD;
          -  Patient willing to provide blood sample for research purposes.&#xD;
&#xD;
          -  Ability of the patient to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior treatment with neurotoxic chemotherapy, such as oxaliplatin, cisplatin,&#xD;
             carboplatin, taxanes or vinca alkaloids.&#xD;
&#xD;
          -  Receiving chemotherapy within 6 months.&#xD;
&#xD;
          -  A family history of a genetic or familial neuropathy&#xD;
&#xD;
          -  Poor compliance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital</name>
      <address>
        <city>Tainan</city>
        <zip>704</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>April 7, 2022</last_update_submitted>
  <last_update_submitted_qc>April 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Cheng-Kung University Hospital</investigator_affiliation>
    <investigator_full_name>Meng-Ru Shen</investigator_full_name>
    <investigator_title>Associate Dean for Research</investigator_title>
  </responsible_party>
  <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/NCT03252834
org study id: B-ER-106-120
nct id: NCT03252834
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a prospective, single arm, single center study evaluating the use of a 4-gene panel
      to predict the occurrence of chemotherapy-induced abnormal thermal threshold in endometrial
      and ovarian cancer patients receiving post-operative chemotherapy with
      Carboplatin/Paclitaxel, and stage III colorectal cancer patients receiving adjuvant
      chemotherapy with mFOLFOX6. A total of 100 patients will be enrolled during 2017 July~ 2019
      June. Blood sample will be collected before chemotherapy to analyze the genetic variants of
      TRPV1, TRPM2, TRPA1 and ORAI1. All patients will receive neurologic examination (Quantitative
      Sensory Test, QST) and complete the questionnaires for quality of life (EQ5D & CIPN20). The
      primary endpoint of this study is to test if the genetic variant of TRPV1, TRPM2, TRPA1, and
      ORAI1 is a predictive biomarker for the chemotherapy-induced abnormal thermal sensation in
      cancer patients.
observational model: Cohort
time perspective: Prospective
measure: The change of thermal pain threshold
time frame: before chemotherapy & 3, 6, and 9 months after chemotherapy
description: The threshold of detecting heat-induced pain
arm group label: Patients with endometrial or ovarian cancer
arm group label: Patients with colorectal cancer
intervention type: Diagnostic Test
intervention name: Genetic variants of TRPV1, TRPM2, TRPA1 and ORAI
description: Genetic variants of TRPV1, TRPM2, TRPA1 and ORAI1 will be analyzed. Quantitative Sensory Test, QST, will be used to determined if there is abnormal thermal sensation.
arm group label: Patients with colorectal cancer
arm group label: Patients with endometrial or ovarian cancer
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Cheng-Kung University Hospital
investigator full name: Meng-Ru Shen
investigator title: Associate Dean for Research
sharing ipd: No