<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/NCT02981043</url>
  </required_header>
  <id_info>
    <org_study_id>23924</org_study_id>
    <nct_id>NCT02981043</nct_id>
  </id_info>
  <brief_title>Does &quot;Aggressivity&quot; of Endometriosis Correlate to Clinical History or Outcomes?</brief_title>
  <acronym>Aggressivity</acronym>
  <official_title>Does &quot;Aggressivity&quot; of Endometriosis Correlate to Clinical History or Outcomes?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Louis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Louis University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Clinical studies so far have been limited, and larger volume and multi-center studies studies&#xD;
      are needed. The purpose of this pilot study is to look for a clinical correlations between&#xD;
      the aggressivity panel developed from biomarkers thought to affect the progression or&#xD;
      aggressivity of endometriosis, pain and quality of life.&#xD;
&#xD;
      Our goal with the study is find a correlation between the &quot;aggressivity&quot; of endometriosis&#xD;
      with clinical factors determined in our study questionnaires. The &quot;aggressivity panel&quot; was&#xD;
      pioneered by the EndoDiag lab in France, and was created using markers thought to affect the&#xD;
      activity or progression of endometriosis. This information could lead to a better&#xD;
      understanding of the disease, and ultimately lead to more targeted therapies.&#xD;
&#xD;
      If a patient returns for a second surgery we will ask their permission to use their slides&#xD;
      from their first and seconed surgery to compare. The tissue that is being removed during the&#xD;
      surgery as standard of care to make slides for the research study (there will not be an&#xD;
      endometrial biopsy performed for research purposes with the second surgery). The slides from&#xD;
      surgery 1 &amp; surgery 2 will then be compared.&#xD;
&#xD;
      If a clinical correlation is found with the aggressivity panel, the goal would be to create a&#xD;
      local lab and tissue bank here in the United States that could provide a basis for&#xD;
      collaborative national (even international) research. Also, if a correlation is found, future&#xD;
      investigation will look at correlations of the aggressivity panel and fertility outcomes.&#xD;
      Results of this pilot study will help to direct studies of treatment protocols of the various&#xD;
      stages of aggressivity of endometriosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study design is an investigator-initiated pilot, prospective cohort study (Canadian Task&#xD;
      Force, II-3). Patients will not be randomized.&#xD;
&#xD;
      Consecutive subjects from age 14-55 will be recruited and included in the study if they are&#xD;
      seeking treatment of pain and with suspected or known endometriosis. Patients who are&#xD;
      menopausal (either chemically-induced, natural or surgical) will not be included in the&#xD;
      study. Patients who are pregnant are not eligible for surgery, and not eligible to be in the&#xD;
      study. Subjects will be excluded if they are found not to have endometriosis confirmed by&#xD;
      histology. All surgeries are performed at a single institution, St. Mary's Hospital.&#xD;
&#xD;
      An ad hoc sample size calculation is not possible for this pilot study, since we have no&#xD;
      historic data on which to base such a calculation. The goal is to acquire 45 panel results,&#xD;
      as a reasonable amount of data for a pilot study, and given the funding available.&#xD;
&#xD;
      Quality of life (measured by the 100-point scale and by the EHP-5) and pain indices (measured&#xD;
      by the VAS scale) will be measured at up to six different time points: before surgery, six&#xD;
      months after surgery, and one year after each surgery. At each time point you will compare&#xD;
      quality of life and each pain index across the four aggressivity groups of low, moderate,&#xD;
      medium, and high using analysis of variance (ANOVA) or the non-parametric Kruskal-Wallis test&#xD;
      depending on the normality of the distributions. Pairwise comparisons will also be made using&#xD;
      independent students t test or the non-parametric Kolmogorov-Smirnov test depending on the&#xD;
      normality of the distributions.&#xD;
&#xD;
      The follow-up time frame for each surgery will be 1 year. Patients will receive&#xD;
      questionnaires pre op and at 6-months and 1 year for both the first surgery and the second&#xD;
      surgery( if needed). The entire study will take about 4 years, including data analysis and&#xD;
      publication. .&#xD;
&#xD;
      This study is related to IRB #20900. Subjects who consent to participate in this study may&#xD;
      also be consented to participate in 20900. The pre-operative and follow-up questionnaires,&#xD;
      and the standardized tools relating to QOL and depression are the same as in IRB#20900.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2013</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</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>Survey: &quot;how aggressive the endometriosis might be&quot;</measure>
    <time_frame>At Surgery</time_frame>
  </primary_outcome>
  <enrollment type="Actual">45</enrollment>
  <condition>Endometriosis</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      1. Blood EDTA (about 10ml) (study related).&#xD;
&#xD;
        2. Peritoneal tissue (about 3-4 samples each the size of 1 tsp) (SOC)&#xD;
&#xD;
        3. Peritoneal fluid, if present (up to 100cc) (SOC) 4 Endometrial biopsy (1/4 to 1/2 inch&#xD;
           long, (1/8 to 1/4 in width) (several SOC biopsies will be taken and one will be sent for&#xD;
           research).&#xD;
&#xD;
      5. Possibly small amount of ovarian tissue (if abnormal) (about size of 1 tsp) (SOC)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will be identified, learn of the research and be recruited from the investigator's&#xD;
        patient population.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female patients&#xD;
&#xD;
          -  14-55 years of age&#xD;
&#xD;
          -  Anyone seen at the Center for Endometriosis, including patients referred for the&#xD;
             evaluation and management of pelvic pain&#xD;
&#xD;
          -  Subjects must be having excision surgery for their endometriosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior bilateral salpingo-oophorectomy, or post natural menopause&#xD;
&#xD;
          -  Significant mental or chronic systemic illness that might confound pain assessment or&#xD;
             the inability to complete the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>October 4, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>August 23, 2018</last_update_submitted>
  <last_update_submitted_qc>August 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Louis University</investigator_affiliation>
    <investigator_full_name>Patrick Yeung Jr., MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometriosis</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/NCT02981043
org study id: 23924
nct id: NCT02981043
lead sponsor: 
has dmc: No
Clinical studies so far have been limited, and larger volume and multi-center studies studies
      are needed. The purpose of this pilot study is to look for a clinical correlations between
      the aggressivity panel developed from biomarkers thought to affect the progression or
      aggressivity of endometriosis, pain and quality of life.

      Our goal with the study is find a correlation between the "aggressivity" of endometriosis
      with clinical factors determined in our study questionnaires. The "aggressivity panel" was
      pioneered by the EndoDiag lab in France, and was created using markers thought to affect the
      activity or progression of endometriosis. This information could lead to a better
      understanding of the disease, and ultimately lead to more targeted therapies.

      If a patient returns for a second surgery we will ask their permission to use their slides
      from their first and seconed surgery to compare. The tissue that is being removed during the
      surgery as standard of care to make slides for the research study (there will not be an
      endometrial biopsy performed for research purposes with the second surgery). The slides from
      surgery 1 & surgery 2 will then be compared.

      If a clinical correlation is found with the aggressivity panel, the goal would be to create a
      local lab and tissue bank here in the United States that could provide a basis for
      collaborative national (even international) research. Also, if a correlation is found, future
      investigation will look at correlations of the aggressivity panel and fertility outcomes.
      Results of this pilot study will help to direct studies of treatment protocols of the various
      stages of aggressivity of endometriosis.
The study design is an investigator-initiated pilot, prospective cohort study (Canadian Task
      Force, II-3). Patients will not be randomized.

      Consecutive subjects from age 14-55 will be recruited and included in the study if they are
      seeking treatment of pain and with suspected or known endometriosis. Patients who are
      menopausal (either chemically-induced, natural or surgical) will not be included in the
      study. Patients who are pregnant are not eligible for surgery, and not eligible to be in the
      study. Subjects will be excluded if they are found not to have endometriosis confirmed by
      histology. All surgeries are performed at a single institution, St. Mary's Hospital.

      An ad hoc sample size calculation is not possible for this pilot study, since we have no
      historic data on which to base such a calculation. The goal is to acquire 45 panel results,
      as a reasonable amount of data for a pilot study, and given the funding available.

      Quality of life (measured by the 100-point scale and by the EHP-5) and pain indices (measured
      by the VAS scale) will be measured at up to six different time points: before surgery, six
      months after surgery, and one year after each surgery. At each time point you will compare
      quality of life and each pain index across the four aggressivity groups of low, moderate,
      medium, and high using analysis of variance (ANOVA) or the non-parametric Kruskal-Wallis test
      depending on the normality of the distributions. Pairwise comparisons will also be made using
      independent students t test or the non-parametric Kolmogorov-Smirnov test depending on the
      normality of the distributions.

      The follow-up time frame for each surgery will be 1 year. Patients will receive
      questionnaires pre op and at 6-months and 1 year for both the first surgery and the second
      surgery( if needed). The entire study will take about 4 years, including data analysis and
      publication. .

      This study is related to IRB #20900. Subjects who consent to participate in this study may
      also be consented to participate in 20900. The pre-operative and follow-up questionnaires,
      and the standardized tools relating to QOL and depression are the same as in IRB#20900.
observational model: Cohort
time perspective: Prospective
measure: Survey: "how aggressive the endometriosis might be"
time frame: At Surgery
1. Blood EDTA (about 10ml) (study related).

        2. Peritoneal tissue (about 3-4 samples each the size of 1 tsp) (SOC)

        3. Peritoneal fluid, if present (up to 100cc) (SOC) 4 Endometrial biopsy (1/4 to 1/2 inch
           long, (1/8 to 1/4 in width) (several SOC biopsies will be taken and one will be sent for
           research).

      5. Possibly small amount of ovarian tissue (if abnormal) (about size of 1 tsp) (SOC)
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 14 Years
maximum age: 55 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: St. Louis University
investigator full name: Patrick Yeung Jr., MD
investigator title: Principal Investigator
mesh term: Endometriosis
sharing ipd: No