<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/NCT03229187</url>
  </required_header>
  <id_info>
    <org_study_id>2016-NACT-01</org_study_id>
    <nct_id>NCT03229187</nct_id>
  </id_info>
  <brief_title>Specific Molecular Signatures Predict Neoadjuvant Chemotherapy Response in Cervical Cancer</brief_title>
  <official_title>Accurate Prediction and Validation of Response to Neoadjuvant Chemotherapy in Cervical Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Huazhong University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wuhan Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Huazhong University of Science and Technology</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cervical cancer is one of the major health problems for chinese women. Besides surgery and&#xD;
      radiotherapy, neoadjuvant chemotherapy has been proved to be an effective program by many&#xD;
      studies.&#xD;
&#xD;
      However, not all patients respond well to neoadjuvant chemotherapy. Knowing the therapeutic&#xD;
      effect of the neoadjuvant chemotherapy before receiving it can not only reduce the economic&#xD;
      burden, but also more importantly save time to take more suitable treatments.&#xD;
&#xD;
      This study is undertaken to build specific molecular signatures to predict the effects of&#xD;
      neoadjuvant chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Anticipated">September 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>The clinical response to neoadjuvant chemotherapy</measure>
    <time_frame>1 to 3 months</time_frame>
    <description>clinical response（tumor size）</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The pathological response to neoadjuvant chemotherapy</measure>
    <time_frame>1 to 3 months</time_frame>
    <description>pathological response（&lt;3 mm or not）</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Uterine Cervical Neoplasms</condition>
  <condition>Cervical Cancer</condition>
  <condition>Uterine Cervical Cancer</condition>
  <arm_group>
    <arm_group_label>neoadjuvant chemotherapy</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Samples with DNA from blood and tissues.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with histologically confirmed Ib~ IIb cervical carcinoma underwent Neoadjuvant&#xD;
        Chemotherapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Untreated cervical cancer with FIGO stage Ib-IIb&#xD;
&#xD;
          -  Measurable lesions&#xD;
&#xD;
          -  Possible to radical hysterectomy&#xD;
&#xD;
          -  Age: 18 and older&#xD;
&#xD;
          -  Karnofsky Performance Status≥ 70.&#xD;
&#xD;
          -  WBC &gt; 3,000/mm³, Hb &gt; 9.0g/dl, Platelet &gt; 100,000 /mm³, SGOT/SGPT &lt; 60 IU/L, T-Bil &lt;&#xD;
             1.5 mg/dL, Cr &lt; 1.2 mg/dL, PaO2 &gt; 80 torr, normal ECG&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous history of cancer&#xD;
&#xD;
          -  Patients with previous treatment&#xD;
&#xD;
          -  Patients without information of clinical risk factors&#xD;
&#xD;
          -  Patients who have active infection&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Ma Ding, M.D.</last_name>
    <phone>86-27-8362681</phone>
    <email>dma@tjh.tjmu.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tongji Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ma Ding, M.D.</last_name>
      <phone>86-27-8362681</phone>
      <email>dma@tjh.tjmu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Huazhong University of Science and Technology</investigator_affiliation>
    <investigator_full_name>Ding Ma</investigator_full_name>
    <investigator_title>Director of Department of Gynecology and Obstetrics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT03229187
org study id: 2016-NACT-01
nct id: NCT03229187
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Cervical cancer is one of the major health problems for chinese women. Besides surgery and
      radiotherapy, neoadjuvant chemotherapy has been proved to be an effective program by many
      studies.

      However, not all patients respond well to neoadjuvant chemotherapy. Knowing the therapeutic
      effect of the neoadjuvant chemotherapy before receiving it can not only reduce the economic
      burden, but also more importantly save time to take more suitable treatments.

      This study is undertaken to build specific molecular signatures to predict the effects of
      neoadjuvant chemotherapy.
observational model: Other
time perspective: Prospective
measure: The clinical response to neoadjuvant chemotherapy
time frame: 1 to 3 months
description: clinical response（tumor size）
measure: The pathological response to neoadjuvant chemotherapy
time frame: 1 to 3 months
description: pathological response（<3 mm or not）
arm group label: neoadjuvant chemotherapy
Samples with DNA from blood and tissues.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
last name: Ma Ding, M.D.
phone: 86-27-8362681
email: dma@tjh.tjmu.edu.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Huazhong University of Science and Technology
investigator full name: Ding Ma
investigator title: Director of Department of Gynecology and Obstetrics
mesh term: Uterine Cervical Neoplasms