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NCT Number: NCT06502548

Endometriosis Transcriptomic Cell Atlas

Endometriosis is an estrogen-dependent, chronic inflammatory gynecologic disease affecting women of reproductive age, with a therapeutic wandering of 6 to 10 years. A better understanding of the initiation phase is a major challenge to improve diagnosis and treatment. The most widely accepted hypothesis to explain the formation of endometriotic lesions is the tubal retrograde reflux during menstruation. However, only 10% of the reproductive age women will develop endometriosis while 90% of women experience retrograde menstruation. This raises the question of the stem cells present in the endometrium and menstrual reflux of these patients, but also of both the peritoneal microenvironment and the estrogenic local signaling which allow the implantation of these lesions.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Toulouse

Toulouse, France

Location status: Recruiting

Location contact

Elodie CHANTALAT, MD

CONTACT

[email protected]

Elodie CHANTALAT, MD

PRINCIPAL_INVESTIGATOR

About this study

Using tissues collected at different phases of menstrual cycle in healthy women and patients operated for endometriotic lesions, 3 main objectives :

  • To characterize cellular heterogeneity between eutopic endometrium and ectopic lesions in parallel with peritoneal fluid to identify potential stem cells and the immune microenvironment in order to find new biomarkers (using a combination of unbiased transcriptomic, spectral flow cytometry and multiplex imaging analysis)
  • To develop organoid models that integrate peritoneal fluid elements (supernatant and/or cells) to clarify stem cell properties/characteristics and their supportive environment
  • To leverage the use of these endometrial derived-organoids to functionally study the differential influence of estrogen signaling in women with or without endometriosis

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients over 18 and under 45 years of age
  • Patients with multiple endometriosis sites (superficial, deep and endometriomas) with an indication for surgery to treat disabling painful symptoms and stage III or IV endometriosis in the context of infertility.
  • Healthy patients including those operated on between the ages of 18 and 45 for tubal ligation
  • Healthy patients operated on between the ages of 18 and 45 for hysterectomies for benign causes other than endometriosis or adenomyosis
  • Patients operated on strictly at the time of menstruation
  • Participants who have not been on hormonal treatment for 2 months
  • Participant having signed the free and informed consent form
  • Membership of a Social Security scheme or equivalent

Exclusion criteria

  • Patients with endometriosis non-surgically treated
  • Patients with endometriosis receiving hormonal treatment at the time of surgery or having received hormonal treatment in the 2 months prior to surgery
  • Patients with adenomyosis only
  • Healthy non-endometriotic patients undergoing hysterectomy for infectious or malignant causes
  • Patients benefiting from a legal protection measure (guardianship, curatorship, safeguard of justice)
  • Patients with positive serology for human immunodeficiency virus (HIV), human T-lymphotropic virus (HTLV), hepatitis B (HBV) and hepatitis C (HCV)

Treatment and study plan

Endometriosis

Procedure

Anatomopathology waste will be recovered, i.e. the remainder of the endometriosis lesions and the remainder of the endometrial biopsy.

A blood sample will be taken the day before surgery, as part of the treatment, for a hormonal check-up.

Tubal ligation or Hysterectomy

Procedure

During surgery, an endometrial biopsy will be taken for research purposes. A blood sample will be taken the day before surgery, as part of the treatment, for a hormonal check-up.

Primary outcomes

  1. Analyze of the number of the different cell types (immune cells and endometrial stem cells) present in the endometrium of healthy control patients

    Time frame: During surgery

  2. Analyze of the number of the different cell types (immune cells and endometrial stem cells) present in the peritoneal fluid of healthy control patients

    Time frame: During surgery

  3. Analyze of the number of the different cell types (immune cells and endometrial stem cells) present in endometriosis lesions for endometriosis patients.

    Time frame: During surgery

  4. Analyze of the number of the different cell types (immune cells and endometrial stem cells) present in endometrium of endometriosis patients.

    Time frame: During surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Elodie CHANTALAT, MD

CONTACT

[email protected]

0561323953 ext. +33

Françoise LENFANT, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

Establishing an Endometriosis Transcriptomic Cell Atlas to Decipher the Pathophysiological Role of Stem Cells and Estrogens in the Disease

Acronym: EDISON

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 16, 2024
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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