<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/NCT03806075</url>
  </required_header>
  <id_info>
    <org_study_id>2017JZ13</org_study_id>
    <nct_id>NCT03806075</nct_id>
  </id_info>
  <brief_title>Study of Accurate Diagnosis and Treatment of Peutz-Jeghers Syndrome</brief_title>
  <official_title>Molecular Typing and Precise Prevention and Treatment of Peutz-Jeghers Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yiqi Du</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Changhai Hospital</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The mutation of STK11 has been regcognized to be the major cause of Peutz-Jeghers syndrome&#xD;
      (PJS).The aim of this study was to confirm the mutation rate of gene associated with&#xD;
      gastrointestinal malignancies,including STK11, APC,PMS1,et al. Furtherly, the investigators&#xD;
      analyze the association of STK11 with gut microbiota.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients diagnosed as PJS were enrolled and accepted second generation gene sequencing&#xD;
      with their blood specimens. Then all patients allocated into gene mutation group and no gene&#xD;
      mutation group according to if the cases accompany with gene mutation of STK11.Also, health&#xD;
      persons were enrolled and a case controlled study will be carried out.All patients and health&#xD;
      persons accepted 16s rRNA sequencing with their feces specimens.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Anticipated">September 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>All patients with Peutz-Jeghers were enrolled and accepted second generation gene sequencing. Then all patients allocated into gene mutation group and no gene mutation group according to if the cases accompany with gene mutation of STK11.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mutation of gene associated with Peutz-Jeghers syndrome</measure>
    <time_frame>2 years</time_frame>
    <description>Mutation of gene associated with Peutz-Jeghers syndrome, including STK11, APC,PMS1,PMS2 et al.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intestinal microbiota of patients with PJS</measure>
    <time_frame>1year</time_frame>
    <description>Identify the variation of intestinal microbiota of patients with PJS</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The association of STK11 with intestinal microbiota of patients with PJS</measure>
    <time_frame>1 year</time_frame>
    <description>The association of STK11 with intestinal microbiota of patients with PJS</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Peutz-Jeghers Syndrome</condition>
  <arm_group>
    <arm_group_label>Peutz-Jeghers patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All Peutz-Jeghers patients meet the clinical criteria</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Health persons</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Those without Peutz-Jeghers syndrome</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Second generation sequencing</intervention_name>
    <description>Firstly, all Peutz-Jeghers patients accept second generation gene sequencing with their blood specimen</description>
    <arm_group_label>Peutz-Jeghers patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>16s rRNA gene sequencing</intervention_name>
    <description>Secondly, All patients and Health persons accepted 16s rRNA gene sequencing with their feces specimen</description>
    <arm_group_label>Health persons</arm_group_label>
    <arm_group_label>Peutz-Jeghers patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject with ages from 18-70 years old.&#xD;
&#xD;
          2. Subject diagnosed with Peutz-Jeughers syndrome.&#xD;
&#xD;
          3. Subject without hypertension, diabetes and other gastrointestinal diseases.&#xD;
&#xD;
          4. The consent form has been signed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject is younger than 18 years or older than 70 years.&#xD;
&#xD;
          2. Subject with hypertension,diabetes and other gastrointestinal diseases.&#xD;
&#xD;
          3. Subject taken or adminstered medicine associated with digestive function during latest&#xD;
             1 month.&#xD;
&#xD;
          4. Pregnant women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yiqi Du, Ph.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Changhai Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yuxin Wang, Ph.D.</last_name>
    <phone>86-18721819083</phone>
    <email>18721819083@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Changhai Hospital</name>
      <address>
        <city>Shanghai</city>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuxin Wang, Ph.D.</last_name>
      <phone>86-18721819083</phone>
      <email>18721819083@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 13, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>January 15, 2019</last_update_submitted>
  <last_update_submitted_qc>January 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Changhai Hospital</investigator_affiliation>
    <investigator_full_name>Yiqi Du</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Second generation gene sequencing, gut microbiota, Gastrointestinal polyp syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peutz-Jeghers Syndrome</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/NCT03806075
org study id: 2017JZ13
nct id: NCT03806075
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The mutation of STK11 has been regcognized to be the major cause of Peutz-Jeghers syndrome
      (PJS).The aim of this study was to confirm the mutation rate of gene associated with
      gastrointestinal malignancies,including STK11, APC,PMS1,et al. Furtherly, the investigators
      analyze the association of STK11 with gut microbiota.
All patients diagnosed as PJS were enrolled and accepted second generation gene sequencing
      with their blood specimens. Then all patients allocated into gene mutation group and no gene
      mutation group according to if the cases accompany with gene mutation of STK11.Also, health
      persons were enrolled and a case controlled study will be carried out.All patients and health
      persons accepted 16s rRNA sequencing with their feces specimens.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: All patients with Peutz-Jeghers were enrolled and accepted second generation gene sequencing. Then all patients allocated into gene mutation group and no gene mutation group according to if the cases accompany with gene mutation of STK11.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Mutation of gene associated with Peutz-Jeghers syndrome
time frame: 2 years
description: Mutation of gene associated with Peutz-Jeghers syndrome, including STK11, APC,PMS1,PMS2 et al.
measure: Intestinal microbiota of patients with PJS
time frame: 1year
description: Identify the variation of intestinal microbiota of patients with PJS
measure: The association of STK11 with intestinal microbiota of patients with PJS
time frame: 1 year
description: The association of STK11 with intestinal microbiota of patients with PJS
arm group label: Peutz-Jeghers patients
arm group type: Experimental
description: All Peutz-Jeghers patients meet the clinical criteria
arm group label: Health persons
arm group type: Placebo Comparator
description: Those without Peutz-Jeghers syndrome
intervention type: Behavioral
intervention name: Second generation sequencing
description: Firstly, all Peutz-Jeghers patients accept second generation gene sequencing with their blood specimen
arm group label: Peutz-Jeghers patients
intervention type: Behavioral
intervention name: 16s rRNA gene sequencing
description: Secondly, All patients and Health persons accepted 16s rRNA gene sequencing with their feces specimen
arm group label: Health persons
arm group label: Peutz-Jeghers patients
criteria: 
gender: All
minimum age: 5 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yiqi Du, Ph.D.
role: Study Chair
affiliation: Changhai Hospital
last name: Yuxin Wang, Ph.D.
phone: 86-18721819083
email: 18721819083@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Changhai Hospital
investigator full name: Yiqi Du
investigator title: Professor
mesh term: Peutz-Jeghers Syndrome
mesh term: Syndrome
sharing ipd: No