Clinical and Molecular Study of Endometriosis and Adenomyosis

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Brief Title

Clinical and Molecular Study of Endometriosis and Adenomyosis

Official Title

ENDOCHAP Monocentric Cohort: Clinical and Molecular Study of Endometriosis and Adenomyosis

Brief Summary

      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.
    

Detailed Description

      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.
    


Study Type

Observational [Patient Registry]


Primary Outcome

Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates

Secondary Outcome

 Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates

Condition

Endometriosis

Intervention

Biological/Vaccine

Study Arms / Comparison Groups

 Patient with benign gynaecologic disease
Description:  Patients consulting for endometriosis, pelvic pain, abnormal uterine bleeding and/or infertility, or for a pelvic mass,

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

5300

Start Date

May 2006

Completion Date

December 2040

Primary Completion Date

June 2040

Eligibility Criteria

        Inclusion Criteria:

          -  Women of age between - 18 and 42 years old.

          -  In-service care for one of the pelvic pain and/or infertility, or for a pelvic mass.

          -  Having a radiological diagnosis made by a referral practitioner and/or operated in the
             department

        Exclusion Criteria:

          -  HIV-positive women, HBV and HCV

          -  During pregnancy

          -  Having a cancer diagnosis

          -  Refusing to sign a consent.
      

Gender

Female

Ages

18 Years - 42 Years


Contacts

Louis Marcellin, MD, PhD, 1 58 41 19 33, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT04481321

Organization ID

NI18108


Responsible Party

Sponsor

Study Sponsor

Assistance Publique - Hôpitaux de Paris


Study Sponsor

Louis Marcellin, MD, PhD, Principal Investigator, Assistance Publique - Hôpitaux de Paris


Verification Date

July 2020