<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/NCT03272360</url>
  </required_header>
  <id_info>
    <org_study_id>EP-002</org_study_id>
    <nct_id>NCT03272360</nct_id>
  </id_info>
  <brief_title>Endometriosis Biomarker Discovery Study</brief_title>
  <acronym>EMBARK</acronym>
  <official_title>A Prospective Sample Collection Study in Patients With Pelvic Pain Undergoing Laparoscopy for Biomarker Identification in Endometriosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Myriad Genetic Laboratories, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Myriad Genetic Laboratories, Inc.</source>
  <brief_summary>
    <textblock>
      This is a prospective, Single time point, discovery study intending to identify biomarkers&#xD;
      that can differentiate endometriosis from other underlying reasons for pelvic pain. Patients&#xD;
      undergoing laparoscopy for evaluation of chronic pelvic pain or elective tubal ligation will&#xD;
      be enrolled for collection of tissue samples at the time of laparoscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be a prospective collection of blood, urine, and endometrial tissue from&#xD;
      women with chronic pelvic pain symptoms, with or without infertility, who require evaluation&#xD;
      by laparoscopy. Women undergoing laparoscopy for elective tubal ligation will also be&#xD;
      investigated similarly and serve as the negative control. Subjects will be queried regarding&#xD;
      sociodemographic characteristics, medical and reproductive history, pain and lifestyle as&#xD;
      well as assessment for differential diagnoses such as interstitial cystitis and idiopathic&#xD;
      bowel syndrome. Endometriosis severity will be captured by rASRM staging during laparoscopy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    company decision to suspend project&#xD;
  </why_stopped>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2017</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>The identification of biomarker(s) that are differentially expressed in endometriosis in the context of pelvic pain</measure>
    <time_frame>Baseline (pre-operative)</time_frame>
    <description>The primary variables will be the DiscoveryMAP analytes identified in blood and/or urine and the mRNA transcriptome in endometrial tissue. DiscoveryMAP is a comprehensive, quantitative platform of immunoassays evaluating multiple analytes in various body system categories: cytokines, chemokines, metabolic markers, hormones, growth factors, tissue remodeling proteins, angiogenesis markers, acute phase reactants, and cancer markers</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The identification of biomarker(s) that are associated with endometriosis severity</measure>
    <time_frame>Baseline (pre-operative)</time_frame>
    <description>The secondary variables will be measures of endometriosis severity: rASRM staging of endometriosis and pain severity from clinical survey</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Chronic Pelvic Pain</condition>
  <condition>Endometriosis</condition>
  <arm_group>
    <arm_group_label>Chronic Pelvic Pain</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Elective Tubal Ligation</arm_group_label>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum, plasma, whole blood, urine, and endometrial tissue&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Women seeking care at OB/GYN clinics and fertility centers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Able to give informed consent.&#xD;
&#xD;
          2. Aged 18-45 years old who has a regular menstrual cycle (26 to 32 days in length).&#xD;
&#xD;
          3. Undergoing a planned diagnostic or therapeutic laparoscopy for the indication of&#xD;
             pelvic pain or for elective tubal ligation.&#xD;
&#xD;
          4. One prior pregnancy for tubal ligation patients.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior surgical diagnosis of endometriosis.&#xD;
&#xD;
          2. Currently pregnant or breastfeeding.&#xD;
&#xD;
          3. Clinical suspicion of pelvic inflammatory disease (PID) or urinary tract infection.&#xD;
&#xD;
          4. Current malignancy except non-melanoma skin cancer adequately treated.&#xD;
&#xD;
          5. Known major systemic disease, including but not limited to inflammatory disease,&#xD;
             autoimmune disease.&#xD;
&#xD;
          6. Use of immunosuppressants in the past 3 months.&#xD;
&#xD;
          7. Use of injectable reproductive hormonal therapy within the past 3 months and have not&#xD;
             menstruated since last dose.&#xD;
&#xD;
          8. If reproductive hormonal implant has been used in the past, it must have been removed&#xD;
             &gt; 3 months prior to study entry and subject must have menstruated since removal.&#xD;
&#xD;
          9. Use of intrauterine device (IUD) in the past 3 months.&#xD;
&#xD;
         10. Use of any other reproductive hormone therapy within the past 3 months, except for&#xD;
             oral contraceptives (OCPs).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>September 6, 2016</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>August 31, 2017</last_update_submitted>
  <last_update_submitted_qc>August 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometriosis</mesh_term>
    <mesh_term>Pelvic Pain</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/NCT03272360
org study id: EP-002
nct id: NCT03272360
lead sponsor: 
This is a prospective, Single time point, discovery study intending to identify biomarkers
      that can differentiate endometriosis from other underlying reasons for pelvic pain. Patients
      undergoing laparoscopy for evaluation of chronic pelvic pain or elective tubal ligation will
      be enrolled for collection of tissue samples at the time of laparoscopy.
This study will be a prospective collection of blood, urine, and endometrial tissue from
      women with chronic pelvic pain symptoms, with or without infertility, who require evaluation
      by laparoscopy. Women undergoing laparoscopy for elective tubal ligation will also be
      investigated similarly and serve as the negative control. Subjects will be queried regarding
      sociodemographic characteristics, medical and reproductive history, pain and lifestyle as
      well as assessment for differential diagnoses such as interstitial cystitis and idiopathic
      bowel syndrome. Endometriosis severity will be captured by rASRM staging during laparoscopy.
observational model: Cohort
time perspective: Prospective
measure: The identification of biomarker(s) that are differentially expressed in endometriosis in the context of pelvic pain
time frame: Baseline (pre-operative)
description: The primary variables will be the DiscoveryMAP analytes identified in blood and/or urine and the mRNA transcriptome in endometrial tissue. DiscoveryMAP is a comprehensive, quantitative platform of immunoassays evaluating multiple analytes in various body system categories: cytokines, chemokines, metabolic markers, hormones, growth factors, tissue remodeling proteins, angiogenesis markers, acute phase reactants, and cancer markers
measure: The identification of biomarker(s) that are associated with endometriosis severity
time frame: Baseline (pre-operative)
description: The secondary variables will be measures of endometriosis severity: rASRM staging of endometriosis and pain severity from clinical survey
arm group label: Chronic Pelvic Pain
arm group label: Elective Tubal Ligation
Serum, plasma, whole blood, urine, and endometrial tissue
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Endometriosis
mesh term: Pelvic Pain