<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/NCT04481321</url>
  </required_header>
  <id_info>
    <org_study_id>NI18108</org_study_id>
    <nct_id>NCT04481321</nct_id>
  </id_info>
  <brief_title>Clinical and Molecular Study of Endometriosis and Adenomyosis</brief_title>
  <acronym>ENDOCHAP</acronym>
  <official_title>ENDOCHAP Monocentric Cohort: Clinical and Molecular Study of Endometriosis and Adenomyosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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 determine whether endometriosis and adenomyosis are&#xD;
      progressive diseases, in terms of symptoms (pain, abnormal uterine bleeding and infertility),&#xD;
      anatomical lesions size, and recurrences. We also aimed to address molecular questions on&#xD;
      immune dialogues between ectopic lesions and the eutopic endometrium, auto-immunity in&#xD;
      endometriosis and adenomyosis and the role of the microbiota in their respective&#xD;
      pathophysiologies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endometriosis and adenomyosis are benign gynecological conditions which affect more than 10%&#xD;
      of women, that typically cause pain and / or infertility, thereby exerting a negative impact&#xD;
      on the patients' quality of life.&#xD;
&#xD;
      Although the pathogenesis of endometriosis and adenomyosis are controversial, both diseases&#xD;
      are defined by the presence of endometrial tissue outside the uterine cavity. Endometriosis&#xD;
      is a heterogeneous disease, with three phenotypes: superficial peritoneal endometriosis&#xD;
      (SUP), ovarian endometrioma (OMA), and deep infiltrating endometriosis (DIE) The most widely&#xD;
      accepted pathophysiological hypothesis for endometriosis is that of the implantation of&#xD;
      ectopic endometrial cells following peritoneal reflux. Endometriosis can be associated with&#xD;
      adenomyosis, also heterogeneous, characterized by the infiltration of endometrial tissue into&#xD;
      the myometrium, presenting different forms: diffuse, focal or cystic.&#xD;
&#xD;
      Due to diseases heterogeneity, the diagnosis of endometriosis and adenomyosis is difficult&#xD;
      and affected patients are subject to a long delay for appropriate management.&#xD;
&#xD;
      We hypothesize that the disease may be progressive in terms of symptoms (pain, abnormal&#xD;
      uterine bleeding and infertility), anatomical lesions and recurrences. Furthermore,&#xD;
      highlighting specific clinical and molecular markers would shorten the diagnostic time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 2006</start_date>
  <completion_date type="Anticipated">December 2040</completion_date>
  <primary_completion_date type="Anticipated">June 2040</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates</measure>
    <time_frame>10 years</time_frame>
    <description>Composite outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in lesions or recurrences to imaging performed during the gynaecological follow-up of the patient</measure>
    <time_frame>10 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates</measure>
    <time_frame>7 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delays between the onset of symptoms and post-operative or radiological histological diagnosis with specialized imaging (transvaginal ultrasound, endorectal ultrasound, magnetic resonance imagingI</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>meeting specific criteria for endometriosis and adenomyosis lesions</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between clinical parameters of interrogation and clinical examination and the presence of endometriosis.</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between clinical parameters of interrogation and clinical examination and the presence of adenomyosis.</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between clinical data and the occurrence of the disease</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Creating a score on clinical diagnosis</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>- Evaluation of individualized management: comparison between different management strategies on pain scores (analog visual scale), pregnancy-conception desire delay, live birth rate</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum dosage of circulating antibodies before and after surgical treatment of lesions</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolic pathway exploration in adenomyosis lesions</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Study of the presence of autoantibodies in cases of endometriosis and adenomyosis</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Establish a genotype/phenotype correlation of the disease (endometriosis and adenomyosis)</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To study the natural history of deep endometriosis lesions and analysis of focused invasion processes, epithelio-mesenchymatous transitions, and fibrogenesis using molecular biology techniques</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characterization of the microbiota in urine and vaginal samples.</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">5300</enrollment>
  <condition>Endometriosis</condition>
  <condition>Adenomyosis</condition>
  <arm_group>
    <arm_group_label>Patient with benign gynaecologic disease</arm_group_label>
    <description>Patients consulting for endometriosis, pelvic pain, abnormal uterine bleeding and/or infertility, or for a pelvic mass,</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Biological/Vaccine</intervention_name>
    <arm_group_label>Patient with benign gynaecologic disease</arm_group_label>
    <other_name>Peripheral blood,</other_name>
    <other_name>Vaginal and urinary swab</other_name>
    <other_name>Endometriosis lesions,endometrial biopsies</other_name>
    <other_name>Myometer biopsies</other_name>
    <other_name>Peritoneal fluid</other_name>
    <other_name>Follicular fluid biopsies</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Peripheral blood, Vaginal and urinary swab, Endometriosis lesions,endometrial biopsies,&#xD;
      Myometer biopsies, Peritoneal fluid, Follicular fluid biopsies&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Women of age between - 18 and 42 years old.&#xD;
&#xD;
          -  In-service care for one of the pelvic pain and/or infertility, or for a pelvic mass.&#xD;
&#xD;
          -  Having a radiological diagnosis made by a referral practitioner and/or operated in the&#xD;
             department.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women of age between - 18 and 42 years old.&#xD;
&#xD;
          -  In-service care for one of the pelvic pain and/or infertility, or for a pelvic mass.&#xD;
&#xD;
          -  Having a radiological diagnosis made by a referral practitioner and/or operated in the&#xD;
             department&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  HIV-positive women, HBV and HCV&#xD;
&#xD;
          -  During pregnancy&#xD;
&#xD;
          -  Having a cancer diagnosis&#xD;
&#xD;
          -  Refusing to sign a consent.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>42 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Louis Marcellin, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Charles Chapron, MD</last_name>
    <phone>1 58 41 19 33</phone>
    <phone_ext>+33</phone_ext>
    <email>charles.chapron@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Laurence Lecomte, PhD</last_name>
    <phone>1 58 41 34 78</phone>
    <phone_ext>+33</phone_ext>
    <email>laurence.lecomte@aphp.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Port Royal, hospital cochin</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Louis Marcellin, MD, PhD</last_name>
      <phone>1 58415495</phone>
      <phone_ext>+33</phone_ext>
      <email>louis.marcellin@aphp.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>November 4, 2022</last_update_submitted>
  <last_update_submitted_qc>November 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Endometriosis</keyword>
  <keyword>Adenomyosis</keyword>
  <keyword>pain</keyword>
  <keyword>infertility</keyword>
  <keyword>disease progressiveness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometriosis</mesh_term>
    <mesh_term>Adenomyosis</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/NCT04481321
org study id: NI18108
nct id: NCT04481321
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine whether endometriosis and adenomyosis are
      progressive diseases, in terms of symptoms (pain, abnormal uterine bleeding and infertility),
      anatomical lesions size, and recurrences. We also aimed to address molecular questions on
      immune dialogues between ectopic lesions and the eutopic endometrium, auto-immunity in
      endometriosis and adenomyosis and the role of the microbiota in their respective
      pathophysiologies.
Endometriosis and adenomyosis are benign gynecological conditions which affect more than 10%
      of women, that typically cause pain and / or infertility, thereby exerting a negative impact
      on the patients' quality of life.

      Although the pathogenesis of endometriosis and adenomyosis are controversial, both diseases
      are defined by the presence of endometrial tissue outside the uterine cavity. Endometriosis
      is a heterogeneous disease, with three phenotypes: superficial peritoneal endometriosis
      (SUP), ovarian endometrioma (OMA), and deep infiltrating endometriosis (DIE) The most widely
      accepted pathophysiological hypothesis for endometriosis is that of the implantation of
      ectopic endometrial cells following peritoneal reflux. Endometriosis can be associated with
      adenomyosis, also heterogeneous, characterized by the infiltration of endometrial tissue into
      the myometrium, presenting different forms: diffuse, focal or cystic.

      Due to diseases heterogeneity, the diagnosis of endometriosis and adenomyosis is difficult
      and affected patients are subject to a long delay for appropriate management.

      We hypothesize that the disease may be progressive in terms of symptoms (pain, abnormal
      uterine bleeding and infertility), anatomical lesions and recurrences. Furthermore,
      highlighting specific clinical and molecular markers would shorten the diagnostic time.
observational model: Cohort
time perspective: Prospective
measure: Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates
time frame: 10 years
description: Composite outcome
measure: Changes in lesions or recurrences to imaging performed during the gynaecological follow-up of the patient
time frame: 10 years
measure: Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates
time frame: 1 year
measure: Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates
time frame: 3 years
measure: Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates
time frame: 5 years
measure: Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates
time frame: 7 years
measure: Delays between the onset of symptoms and post-operative or radiological histological diagnosis with specialized imaging (transvaginal ultrasound, endorectal ultrasound, magnetic resonance imagingI
time frame: 10 years
measure: meeting specific criteria for endometriosis and adenomyosis lesions
time frame: 10 years
measure: Association between clinical parameters of interrogation and clinical examination and the presence of endometriosis.
time frame: 10 years
measure: Association between clinical parameters of interrogation and clinical examination and the presence of adenomyosis.
time frame: 10 years
measure: Association between clinical data and the occurrence of the disease
time frame: 10 years
measure: Creating a score on clinical diagnosis
time frame: 10 years
measure: - Evaluation of individualized management: comparison between different management strategies on pain scores (analog visual scale), pregnancy-conception desire delay, live birth rate
time frame: 10 years
measure: Serum dosage of circulating antibodies before and after surgical treatment of lesions
time frame: 10 years
measure: Metabolic pathway exploration in adenomyosis lesions
time frame: 10 years
measure: Study of the presence of autoantibodies in cases of endometriosis and adenomyosis
time frame: 10 years
measure: Establish a genotype/phenotype correlation of the disease (endometriosis and adenomyosis)
time frame: 10 years
measure: To study the natural history of deep endometriosis lesions and analysis of focused invasion processes, epithelio-mesenchymatous transitions, and fibrogenesis using molecular biology techniques
time frame: 10 years
measure: Characterization of the microbiota in urine and vaginal samples.
time frame: 10 years
arm group label: Patient with benign gynaecologic disease
description: Patients consulting for endometriosis, pelvic pain, abnormal uterine bleeding and/or infertility, or for a pelvic mass,
intervention type: Biological
intervention name: Biological/Vaccine
arm group label: Patient with benign gynaecologic disease
other name: Peripheral blood,
other name: Vaginal and urinary swab
other name: Endometriosis lesions,endometrial biopsies
other name: Myometer biopsies
other name: Peritoneal fluid
other name: Follicular fluid biopsies
Peripheral blood, Vaginal and urinary swab, Endometriosis lesions,endometrial biopsies,
      Myometer biopsies, Peritoneal fluid, Follicular fluid biopsies
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 42 Years
last name: Louis Marcellin, MD, PhD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
last name: Charles Chapron, MD
phone: 1 58 41 19 33
phone ext: +33
email: charles.chapron@aphp.fr
last name: Laurence Lecomte, PhD
phone: 1 58 41 34 78
phone ext: +33
email: laurence.lecomte@aphp.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Endometriosis
mesh term: Adenomyosis
sharing ipd: No