<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/NCT04413656</url>
  </required_header>
  <id_info>
    <org_study_id>SHCHE201902</org_study_id>
    <nct_id>NCT04413656</nct_id>
  </id_info>
  <brief_title>cfDNA Methylation Assay for Clinical Evaluation of Patients With Stage IA Lung Cancer After Ablation Operation</brief_title>
  <official_title>cfDNA Methylation Assay for Clinical Evaluation of Patients With Stage IA Lung Cancer After Ablation Operation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Chest Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Chest 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>
      The objective is to screen and monitor the efficacy of cfDNA methylation in patients with&#xD;
      stage I lung cancer after ablation, to compare the similarities and differences of cfDNA&#xD;
      methylation between surgical treatment and ablation in patients with stage I lung cancer, and&#xD;
      to look for new indicators to assess the efficacy of ablation therapy and to monitor lung&#xD;
      cancer recurrence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective is to screen and monitor the efficacy of cfDNA methylation in patients with&#xD;
      stage I lung cancer after ablation, to compare the similarities and differences of cfDNA&#xD;
      methylation between surgical treatment and ablation in patients with stage I lung cancer, and&#xD;
      to look for new indicators to assess the efficacy of ablation therapy and to monitor lung&#xD;
      cancer recurrence.&#xD;
&#xD;
      The main research content is to screen the cfDNA methylation index that can monitor the&#xD;
      efficacy of stage I lung cancer ablation and compare the similarities and differences of&#xD;
      cfDNA methylation in patients with stage I lung cancer after surgery and ablation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 17, 2019</start_date>
  <completion_date type="Anticipated">June 17, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 17, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Screening and monitoring the change of cfDNA methylation index</measure>
    <time_frame>before surgery , after surgery 1month, 3month, 6month，9month，12month，18month and 24month</time_frame>
    <description>Screening and monitoring the change of cfDNA methylation index in patients with stage I lung cancer after ablation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparing similarities and differences between cfDNA methylation in surgical treatment and ablation</measure>
    <time_frame>before surgery , after surgery 1month, 3month</time_frame>
    <description>Comparing similarities and differences between cfDNA methylation in surgical treatment and ablation of patients with stage I lung cancer</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>ablation group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with stage IA inoperable peripheral lung tumor will be performed ablation. cfDNA methylation would be monitored at different times(before surgery , after surgery 1month, 3month, and every 3month in the first year and every 6 months in the second ). Meanwhile, post-treatment response will be evaluated and follow up will be carried out according to the standard procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>surgery group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with stage IA operable peripheral lung tumor will be performed surgery. cfDNA methylation would be monitored at different time(before surgery , after surgery 1month, 3month). Post-treatment response will be evaluated and follow up will be carried out according to the standard procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ablation</intervention_name>
    <description>Patients with stage IA inoperable peripheral lung tumor will be performed ablation. cfDNA methylation would be monitored at different times(before surgery , after surgery 1month, 3month, and every 3month in the first year and every 6 months in the second ).</description>
    <arm_group_label>ablation group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>surgery</intervention_name>
    <description>Patients with stage IA inoperable peripheral lung tumor will be performed ablation. cfDNA methylation would be monitored at different times(before surgery, after surgery 1month, 3month).</description>
    <arm_group_label>surgery group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age: 18-85 years old;&#xD;
&#xD;
          2. The peripheral pulmonary nodules found in patients with chest CT, preoperative&#xD;
             examination showed that the clinical stage of patients was T1N0M0, IA;&#xD;
&#xD;
          3. patients are not suitable for surgical treatment through multidisciplinary assessment,&#xD;
             agree to accept ablation&#xD;
&#xD;
          4. Patients have good compliance with the tests and follow-ups, understand the situation&#xD;
             of the study and sign informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The patient is generally in poor condition and cannot tolerate the examination;&#xD;
&#xD;
          2. patients with a cardiac pacemaker or stent in the heart; peripheral tumors of the&#xD;
             lungs are adjacent to large blood vessels or important structures;&#xD;
&#xD;
          3. patients with poor compliance;&#xD;
&#xD;
          4. Researchers believe that it is not appropriate to participate in this trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Shanghai Chest Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200030</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jiayuan Sun, MD, PhD</last_name>
      <phone>86-021-22200000-1501</phone>
      <email>jysun1976@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Jiayuan Sun, MD, PhD</last_name>
      <phone>18017321598</phone>
      <email>jysun1976@163.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>November 11, 2019</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Chest Hospital</investigator_affiliation>
    <investigator_full_name>Jiayuan Sun</investigator_full_name>
    <investigator_title>Chief Physician, Department of Pulmonary Medicine, Director, Department of Respiratory Endoscopy and Interventional Pulmonology</investigator_title>
  </responsible_party>
  <keyword>ablation</keyword>
  <keyword>circulating free DNA</keyword>
  <keyword>methylation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung 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>


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/NCT04413656
org study id: SHCHE201902
nct id: NCT04413656
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective is to screen and monitor the efficacy of cfDNA methylation in patients with
      stage I lung cancer after ablation, to compare the similarities and differences of cfDNA
      methylation between surgical treatment and ablation in patients with stage I lung cancer, and
      to look for new indicators to assess the efficacy of ablation therapy and to monitor lung
      cancer recurrence.
The objective is to screen and monitor the efficacy of cfDNA methylation in patients with
      stage I lung cancer after ablation, to compare the similarities and differences of cfDNA
      methylation between surgical treatment and ablation in patients with stage I lung cancer, and
      to look for new indicators to assess the efficacy of ablation therapy and to monitor lung
      cancer recurrence.

      The main research content is to screen the cfDNA methylation index that can monitor the
      efficacy of stage I lung cancer ablation and compare the similarities and differences of
      cfDNA methylation in patients with stage I lung cancer after surgery and ablation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Screening and monitoring the change of cfDNA methylation index
time frame: before surgery , after surgery 1month, 3month, 6month，9month，12month，18month and 24month
description: Screening and monitoring the change of cfDNA methylation index in patients with stage I lung cancer after ablation
measure: Comparing similarities and differences between cfDNA methylation in surgical treatment and ablation
time frame: before surgery , after surgery 1month, 3month
description: Comparing similarities and differences between cfDNA methylation in surgical treatment and ablation of patients with stage I lung cancer
arm group label: ablation group
arm group type: Experimental
description: Patients with stage IA inoperable peripheral lung tumor will be performed ablation. cfDNA methylation would be monitored at different times(before surgery , after surgery 1month, 3month, and every 3month in the first year and every 6 months in the second ). Meanwhile, post-treatment response will be evaluated and follow up will be carried out according to the standard procedure.
arm group label: surgery group
arm group type: Experimental
description: Patients with stage IA operable peripheral lung tumor will be performed surgery. cfDNA methylation would be monitored at different time(before surgery , after surgery 1month, 3month). Post-treatment response will be evaluated and follow up will be carried out according to the standard procedure.
intervention type: Other
intervention name: ablation
description: Patients with stage IA inoperable peripheral lung tumor will be performed ablation. cfDNA methylation would be monitored at different times(before surgery , after surgery 1month, 3month, and every 3month in the first year and every 6 months in the second ).
arm group label: ablation group
intervention type: Other
intervention name: surgery
description: Patients with stage IA inoperable peripheral lung tumor will be performed ablation. cfDNA methylation would be monitored at different times(before surgery, after surgery 1month, 3month).
arm group label: surgery group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Chest Hospital
investigator full name: Jiayuan Sun
investigator title: Chief Physician, Department of Pulmonary Medicine, Director, Department of Respiratory Endoscopy and Interventional Pulmonology
mesh term: Lung Neoplasms
sharing ipd: No