Developing a Complex ex Vivo Endometrial Tissue Model to Improve Endometriosis Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tissue collection, Data collection.
- Who it may be relevant to
- Registry conditions: Endometriosis. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Developing a Complex ex Vivo Endometrial Tissue Model Based on Patient Biopsies to Assess and Optimise the Response to Current and Potential Treatments for Endometriosis
Overview
Endometriosis is a chronic gynaecological disease characterised by the growth of endometrium outside the uterus. It affects 10% of childbearing age women. There is no cure for endometriosis. Hormonal treatments should be the first line therapy. The benefit-risk ratio of symptomatic treatment with hormone therapy varies greatly from one woman to another. The pathophysiology of endometriosis and the mechanisms of action of these treatments are still poorly understood. This may be due to the lack of an optimal experimental model for studying the disease. The aim of this project is to develop a complex ex vivo endometrial model recapitulating the organisation and properties of the human endometrium using innovative tissue bioengineering methods. This model will make it possible to develop a pre-clinical approach that predicts individual response to different types of hormonal treatment in order to optimise therapeutic choices and provide a better understanding of the effects of these treatments.
Interventions
- Procedure Tissue collection
Eutopic and ectopic endometrium biopsies, additional blood and peritoneal fluid sampling - Other Data collection
Questionnaire on menstrual health and history of hormone treatments for the research purpose
Primary outcome measures
- Viability of all the cells forming the complex endometrial tissue generated ex vivo by tissue bioengineering. [Time frame: through study completion, an average of 18 months]
Secondary outcome measures (8)
- Change in protein expression [Time frame: through study completion, an average of 18 months]
- Change in gene expression [Time frame: through study completion, an average of 18 months]
- Change in inflammation [Time frame: through study completion, an average of 18 months]
- Change in histological tissue structure [Time frame: through study completion, an average of 18 months]
- Change in histological tissue structure [Time frame: through study completion, an average of 18 months]
- Change in tissue elasticity [Time frame: through study completion, an average of 18 months]
- Change in steroid hormone physiology [Time frame: At baseline]
- Steroid hormones in peritoneal fluid [Time frame: At baseline]
Eligibility criteria
Inclusion criteria
- Female
- People aged between 18 and 50
- Person who has or has had hormonal contraceptive treatment
- A person who has given written consent
- Person diagnosed with a benign gynaecological pathology not affecting the endometrium and requiring hysterectomy, hysteroscopy or laparoscopy or with a diagnosis of endometriosis and requiring laparoscopy or hysterectomy
- Person affiliated to the french social security
Exclusion criteria
- Pregnant at the time of sampling or within 3 months prior to sampling
- Breast-feeding women
- Women undergoing physiological menopause
- Anyone who has received hormonal treatment with hormones other than steroids in the three months prior to sampling
- Anyone with a non-hormonal contraceptive intrauterine device (copper coil)
- Anyone with a personal history of cancer of the breast, ovary, endometrium or cervix
- People with Lynch syndrome
- Persons under legal protection (guardianship, curatorship)
- Persons deprived of their liberty by judicial or administrative decision
- Persons with a body mass index (BMI) of less than 18.5 or more than 30
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
France · 2 centers
- Hôpital Femme Mère Enfant / GHE — Bron
- Hôpital de la Croix-Rousse / GHN — Lyon
Identifiers
NCT: NCT06331676 · 69HCL23_1120 · 2023-A02339-36