<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/NCT04454853</url>
  </required_header>
  <id_info>
    <org_study_id>PUTH2017351</org_study_id>
    <nct_id>NCT04454853</nct_id>
  </id_info>
  <brief_title>Methylated DNA Detect in Paraneoplastic Syndrome of Nervous System</brief_title>
  <official_title>A Research of Value of Free Methylated DNA Detect in Lung Cancer on the Diagnosis and Treatment of Paraneoplastic Syndrome of Nervous System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University Third Hospital</source>
  <oversight_info>
    <has_dmc>No</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 purpose of this study is to verify whether the cell-free DNA of lung cancer in the blood&#xD;
      can be used as a biomarker for early diagnosis and prognosis evaluation of patient with&#xD;
      paraneoplastic syndrome of the nervous system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Paraneoplastic neurological syndrome (PNS) is a clinical syndrome that affects the central&#xD;
      nervous system, peripheral nerves, neuromuscular junctions and muscles by the distant&#xD;
      influence of the tumor. No tumor cells are visible in the neuropathy. The disease is a rare&#xD;
      clinical syndrome, and lung cancer is the most common type of tumor that causes PNS.If PNS&#xD;
      can be diagnosed when there are no tumor symptoms, not only can the cause of PNS be&#xD;
      identified, but early tumors can be found for treatment time, and measures can be taken in&#xD;
      the early stages of the tumor to improve survival. Tumor free DNA (cell-free DNA, cfDNA)&#xD;
      methylation detection is to determine the cancer condition and cancer type of the subject by&#xD;
      detecting the methylation of free DNA released by tumor cells. In normal cells, tumor&#xD;
      suppressor genes are expressed and proto-oncogenes are silenced; in tumor cells, tumor&#xD;
      suppressor genes are hypermethylated and silenced, and oncogenes are hypomethylated and&#xD;
      activated. The release of free DNA into the blood will be quickly cleared in tens of minutes&#xD;
      to several hours, which can reflect the body's cell damage in real time, and is of great&#xD;
      significance for monitoring the early occurrence and development of the disease. At present,&#xD;
      the sensitivity of lung cancer cf-DNA detection technology is close to 100%, and the&#xD;
      specificity is 94%, which is an effective detection technology for early detection of lung&#xD;
      cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Actual">July 1, 2019</completion_date>
  <primary_completion_date type="Actual">July 1, 2019</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>Level of cf-DNA</measure>
    <time_frame>1 year after recruitment</time_frame>
    <description>Tumor-free DNA (cfDNA) methylation detection is to determine the cancer condition and cancer type of the subject by detecting the methylation of free DNA released by tumor cells.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes of mRS score</measure>
    <time_frame>1 year after recruitment</time_frame>
    <description>Documentation in the medical record of a Modified Rankin Score (mRS). The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire. The Modified Rankin Score (mRS) is the most widely used outcome measure in stroke clinical trials. Standardized interviews to obtain a mRS score are recommended at 3 months (90 days) following hospital discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival time</measure>
    <time_frame>1 years after recruitment</time_frame>
    <description>The time interval from disease diagnosis to death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>1-year mortality rate</measure>
    <time_frame>1 year after recruitment</time_frame>
    <description>The rate of death among all the inclusion patients after 1 year</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of lung cancer</measure>
    <time_frame>1 year after recruitment</time_frame>
    <description>The rate of lung cancer occurence among all the inclusion patients</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Paraneoplastic Neurological Syndrome</condition>
  <arm_group>
    <arm_group_label>Lung cancer with positive methylated DNA</arm_group_label>
    <description>Blood DNA methylation abnormalities are found in lung cancer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lung cancer with negative methylated DNA</arm_group_label>
    <description>Blood DNA methylation abnormalities are not found in lung cancer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Suspected lung cancer with positive methylated DNA</arm_group_label>
    <description>Blood DNA methylation abnormalities are found in suspected lung cancer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Suspected lung cancer with negative methylated DNA</arm_group_label>
    <description>Blood DNA methylation abnormalities are not found in suspected lung cancer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lung cancer</intervention_name>
    <description>Paraneoplastic neurological syndrome (PNS) is a clinical syndrome that affects the central nervous system, peripheral nerves, neuromuscular junctions and muscles by the distant influence of the tumor. No tumor cells are visible at the neuropathy site.</description>
    <arm_group_label>Lung cancer with negative methylated DNA</arm_group_label>
    <arm_group_label>Lung cancer with positive methylated DNA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Suspected lung cancer</intervention_name>
    <description>Paraneoplastic neurological syndrome (PNS) is a clinical syndrome that affects the central nervous system, peripheral nerves, neuromuscular junctions and muscles by the distant influence of the tumor. No tumor cells are visible at the neuropathy site.</description>
    <arm_group_label>Suspected lung cancer with negative methylated DNA</arm_group_label>
    <arm_group_label>Suspected lung cancer with positive methylated DNA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Positive methylated DNA</intervention_name>
    <description>Tumor-free DNA (cfDNA) methylation detection is to determine the cancer condition and cancer type of the subject by detecting the methylation of free DNA released by tumor cells.</description>
    <arm_group_label>Lung cancer with positive methylated DNA</arm_group_label>
    <arm_group_label>Suspected lung cancer with positive methylated DNA</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        We recruited consecutive patients with paraneoplastic syndrome.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The agnogenic typical neurological syndromes (including encephalomyelitis, marginal&#xD;
             encephalitis, subacute cerebellar degeneration, strabismus ocular clonic-myoclonus,&#xD;
             subacute sensory neuron disease, Lambert-Eaton myasthenic syndrome, skin Myositis,&#xD;
             etc.) patient who predisposed to a tumor.&#xD;
&#xD;
          -  Pathologically confirmed as lung cancer or suggested as lung cancer patient by imaging&#xD;
             (pulmonary CT/Positron Emission Tomography-CT), tumor biomarkers, anti-brain tissue&#xD;
             antibodies, etc.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lacunar infarction&#xD;
&#xD;
          -  Aortic atherosclerotic cerebral infarction&#xD;
&#xD;
          -  Clear cardiogenic cerebral infarction&#xD;
&#xD;
          -  Other related system diseases (arteritis, vascular dissection, migraine and vasospasm,&#xD;
             etc.)&#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>Dongsheng Fan, MD.PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University Third Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Paraneoplastic neurological syndrome; Cell-free DNA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paraneoplastic Syndromes</mesh_term>
    <mesh_term>Syndrome</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/NCT04454853
org study id: PUTH2017351
nct id: NCT04454853
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to verify whether the cell-free DNA of lung cancer in the blood
      can be used as a biomarker for early diagnosis and prognosis evaluation of patient with
      paraneoplastic syndrome of the nervous system.
Paraneoplastic neurological syndrome (PNS) is a clinical syndrome that affects the central
      nervous system, peripheral nerves, neuromuscular junctions and muscles by the distant
      influence of the tumor. No tumor cells are visible in the neuropathy. The disease is a rare
      clinical syndrome, and lung cancer is the most common type of tumor that causes PNS.If PNS
      can be diagnosed when there are no tumor symptoms, not only can the cause of PNS be
      identified, but early tumors can be found for treatment time, and measures can be taken in
      the early stages of the tumor to improve survival. Tumor free DNA (cell-free DNA, cfDNA)
      methylation detection is to determine the cancer condition and cancer type of the subject by
      detecting the methylation of free DNA released by tumor cells. In normal cells, tumor
      suppressor genes are expressed and proto-oncogenes are silenced; in tumor cells, tumor
      suppressor genes are hypermethylated and silenced, and oncogenes are hypomethylated and
      activated. The release of free DNA into the blood will be quickly cleared in tens of minutes
      to several hours, which can reflect the body's cell damage in real time, and is of great
      significance for monitoring the early occurrence and development of the disease. At present,
      the sensitivity of lung cancer cf-DNA detection technology is close to 100%, and the
      specificity is 94%, which is an effective detection technology for early detection of lung
      cancer.
observational model: Cohort
time perspective: Prospective
measure: Level of cf-DNA
time frame: 1 year after recruitment
description: Tumor-free DNA (cfDNA) methylation detection is to determine the cancer condition and cancer type of the subject by detecting the methylation of free DNA released by tumor cells.
measure: Changes of mRS score
time frame: 1 year after recruitment
description: Documentation in the medical record of a Modified Rankin Score (mRS). The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire. The Modified Rankin Score (mRS) is the most widely used outcome measure in stroke clinical trials. Standardized interviews to obtain a mRS score are recommended at 3 months (90 days) following hospital discharge.
measure: Survival time
time frame: 1 years after recruitment
description: The time interval from disease diagnosis to death
measure: 1-year mortality rate
time frame: 1 year after recruitment
description: The rate of death among all the inclusion patients after 1 year
measure: Incidence of lung cancer
time frame: 1 year after recruitment
description: The rate of lung cancer occurence among all the inclusion patients
arm group label: Lung cancer with positive methylated DNA
description: Blood DNA methylation abnormalities are found in lung cancer.
arm group label: Lung cancer with negative methylated DNA
description: Blood DNA methylation abnormalities are not found in lung cancer.
arm group label: Suspected lung cancer with positive methylated DNA
description: Blood DNA methylation abnormalities are found in suspected lung cancer.
arm group label: Suspected lung cancer with negative methylated DNA
description: Blood DNA methylation abnormalities are not found in suspected lung cancer.
intervention type: Other
intervention name: Lung cancer
description: Paraneoplastic neurological syndrome (PNS) is a clinical syndrome that affects the central nervous system, peripheral nerves, neuromuscular junctions and muscles by the distant influence of the tumor. No tumor cells are visible at the neuropathy site.
arm group label: Lung cancer with negative methylated DNA
arm group label: Lung cancer with positive methylated DNA
intervention type: Other
intervention name: Suspected lung cancer
description: Paraneoplastic neurological syndrome (PNS) is a clinical syndrome that affects the central nervous system, peripheral nerves, neuromuscular junctions and muscles by the distant influence of the tumor. No tumor cells are visible at the neuropathy site.
arm group label: Suspected lung cancer with negative methylated DNA
arm group label: Suspected lung cancer with positive methylated DNA
intervention type: Other
intervention name: Positive methylated DNA
description: Tumor-free DNA (cfDNA) methylation detection is to determine the cancer condition and cancer type of the subject by detecting the methylation of free DNA released by tumor cells.
arm group label: Lung cancer with positive methylated DNA
arm group label: Suspected lung cancer with positive methylated DNA
plasma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Dongsheng Fan, MD.PHD
role: Principal Investigator
affiliation: Peking University Third Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Paraneoplastic Syndromes
mesh term: Syndrome
sharing ipd: No