<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/NCT03754517</url>
  </required_header>
  <id_info>
    <org_study_id>The reaseon of serofast</org_study_id>
    <nct_id>NCT03754517</nct_id>
  </id_info>
  <brief_title>Finding the Latent Treponema Pallidum</brief_title>
  <official_title>Finding the Latent Treponema Pallidum of Syphilis With Serofast Status</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Some syphilitic patients remain in a serologically positive state after the recommended&#xD;
      therapy. Whether a serofast state could represent a persistent low-level infection by&#xD;
      Treponema pallidum is still unknown. The possibility that persistent nontreponemal antibodies&#xD;
      after treatment represent persistence of Treponema pallidum was raised by some investigators.&#xD;
      The investigators use the Next-Generation Sequencing to test blood plasma, srum,&#xD;
      cerebrospinal fluid, aqueous humor, lymph nodes, skin lesion, saliva, semen,milk of serofast&#xD;
      patient and other positive and negative controls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Some syphilitic patients remain in a serologically positive state after the recommended&#xD;
      therapy. Whether a serofast state could represent a persistent low-level infection by&#xD;
      Treponema pallidum is still unknown. The possibility that persistent nontreponemal antibodies&#xD;
      after treatment represent persistence of Treponema pallidum was raised by some investigators.&#xD;
      The investigators use the Next-Generation Sequencing to test blood plasma, serum,&#xD;
      cerebrospinal fluid, aqueous humor, lymph nodes, skin lesion, saliva, semen,milk of serofast&#xD;
      patient and other positive and negative controls.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 2016</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">November 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>the reads of treponema pallidum</measure>
    <time_frame>30 days</time_frame>
    <description>Using the Next-Generation Sequencing to test specific genome of treponema pallidum for syphilis</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Syphilis</condition>
  <arm_group>
    <arm_group_label>Serofast status</arm_group_label>
    <description>The syphilitic patients who remain in a serologically positive state after therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Untreated</arm_group_label>
    <description>untreated syphilis cases</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Serological cure</arm_group_label>
    <description>In the early syphilis patients, at 6 months following treatment, a serological cure was defined as either a negative RPR or ≥2 dilution (4-fold) decrease in the RPR titer.&#xD;
In the late syphilis patients, at 12 months following treatment, a serological cure was defined as either a negative RPR or ≥2 dilution (4-fold) decrease in the RPR titer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>RPR Titer</intervention_name>
    <description>RPR titer; TPPA/FTA-ABS; Next-Generation Sequencing</description>
    <arm_group_label>Serofast status</arm_group_label>
    <arm_group_label>Serological cure</arm_group_label>
    <arm_group_label>Untreated</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      body fluid&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All syphilis cases.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All clinical diagnosis of syphilis cases&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Auto-immune disease (such as SLE)&#xD;
&#xD;
          -  Lyme disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jun Li</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jun Li</last_name>
    <phone>01069151502</phone>
    <email>lijun35@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>PekingUMCH</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jun Li</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>March 26, 2019</last_update_submitted>
  <last_update_submitted_qc>March 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>syphilis</keyword>
  <keyword>serofast</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syphilis</mesh_term>
    <mesh_term>Treponemal Infections</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/NCT03754517
org study id: The reaseon of serofast
nct id: NCT03754517
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Some syphilitic patients remain in a serologically positive state after the recommended
      therapy. Whether a serofast state could represent a persistent low-level infection by
      Treponema pallidum is still unknown. The possibility that persistent nontreponemal antibodies
      after treatment represent persistence of Treponema pallidum was raised by some investigators.
      The investigators use the Next-Generation Sequencing to test blood plasma, srum,
      cerebrospinal fluid, aqueous humor, lymph nodes, skin lesion, saliva, semen,milk of serofast
      patient and other positive and negative controls.
Some syphilitic patients remain in a serologically positive state after the recommended
      therapy. Whether a serofast state could represent a persistent low-level infection by
      Treponema pallidum is still unknown. The possibility that persistent nontreponemal antibodies
      after treatment represent persistence of Treponema pallidum was raised by some investigators.
      The investigators use the Next-Generation Sequencing to test blood plasma, serum,
      cerebrospinal fluid, aqueous humor, lymph nodes, skin lesion, saliva, semen,milk of serofast
      patient and other positive and negative controls.
observational model: Case-Control
time perspective: Prospective
measure: the reads of treponema pallidum
time frame: 30 days
description: Using the Next-Generation Sequencing to test specific genome of treponema pallidum for syphilis
arm group label: Serofast status
description: The syphilitic patients who remain in a serologically positive state after therapy
arm group label: Untreated
description: untreated syphilis cases
arm group label: Serological cure
description: In the early syphilis patients, at 6 months following treatment, a serological cure was defined as either a negative RPR or ≥2 dilution (4-fold) decrease in the RPR titer.
In the late syphilis patients, at 12 months following treatment, a serological cure was defined as either a negative RPR or ≥2 dilution (4-fold) decrease in the RPR titer.
intervention type: Diagnostic Test
intervention name: RPR Titer
description: RPR titer; TPPA/FTA-ABS; Next-Generation Sequencing
arm group label: Serofast status
arm group label: Serological cure
arm group label: Untreated
body fluid
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jun Li
role: Principal Investigator
affiliation: Peking Union Medical College Hospital
last name: Jun Li
phone: 01069151502
email: lijun35@hotmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Syphilis
mesh term: Treponemal Infections