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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A02339-36 | Other Identifier | ID RCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endometriosis | Experimental | Women with endometriosis who have an indication for gynaecological surgery |
|
| Control | Active Comparator | Women with no endometrial pathology who have an indication for gynaecological surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tissue collection | Procedure | Eutopic and ectopic endometrium biopsies, additional blood and peritoneal fluid sampling |
|
| Measure | Description | Time Frame |
|---|---|---|
| Viability of all the cells forming the complex endometrial tissue generated ex vivo by tissue bioengineering. | The viability of all the cells forming the complex endometrial tissue generated ex vivo by tissue bioengineering will be assessed either by flow cytometry (labelling with propidium iodide or 7-AAD) or by immunofluorescence (with lipophilic carbocyanine dyes). The scientists involved in the project reserve the right to modify these labelling techniques and the markers mentioned, depending on the technical and logistical challenges encountered during the tissue bioengineering stages. | through study completion, an average of 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in protein expression | Comparing changes in protein expression in the model of complex endometrial tissue generated ex vivo by tissue bioengineering (eutopic endometrium) in each donor, between control and endometriosis groups and between eutopic and ectopic endometrium in endometriosis group. | through study completion, an average of 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charles-André PHILIP, M.D., PhD | Contact | 04 27 85 51 70 | +33 | charles-andre.philip01@chu-lyon.fr |
| Axelle BRULPORT, PhD | Contact | axelle.brulport@inserm.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Femme Mère Enfant / GHE | Recruiting | Bron | 69500 | France |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D014015 | Tissue Banks |
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D018070 | Biological Specimen Banks |
| D006268 | Health Facilities |
| D005159 | Health Care Facilities Workforce and Services |
| D004812 | Epidemiologic Methods |
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Participants enrolled in this study will be given an eutopic and ectopic endometrium biopsies, blood and peritoneal fluid sampling and should answer to a questionnaire on menstrual health and history of hormone treatments for the research purpose..
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| Data collection | Other | Questionnaire on menstrual health and history of hormone treatments for the research purpose |
|
| Change in gene expression | Comparing changes in gene expression in the model of complex endometrial tissue generated ex vivo by tissue bioengineering (eutopic endometrium) in each donor, between control and endometriosis groups and between eutopic and ectopic endometrium in endometriosis group. | through study completion, an average of 18 months |
| Change in inflammation | The concentration (expressed in pg/gl) of the following cytokines will be measured using Luminex technology (Bio-Plex 200 analyser): Interleukin (IL) 1β, IL-1RA, IL-2, IL-2R, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12p40/p70, IL-13, IL-15, IL-17, Tumor Necrosis Factor TNFα, interferons (IFN) IFN-α, IFN-γ, Granulocyte-Macrophage Colony Stimulating Factor GM-CSF, Macrophage Inflammatory Protein MIP-1α, MIP-1β, Interferon gamma-induced protein 10 IP-10, Eotaxin, RANTES, and Monocyte Chemoattractant Protein-1 MCP-1. Changes in these inflammation markers concentration in the model of complex endometrial tissue generated ex vivo by tissue bioengineering (eutopic endometrium) in each donor, between control and endometriosis groups and between eutopic and ectopic endometrium in endometriosis group will be assessed. | through study completion, an average of 18 months |
| Change in histological tissue structure | Comparing changes in histological tissue structure (density of glands open to the lumen and glands located in the basal layer of the endometrium expressed in number of glands/cm3 of tissue, measured with an haematoxiline-eosin stainings and using Image J software) in the model of complex endometrial tissue generated ex vivo by tissue bioengineering (eutopic endometrium) in each donor, between control and endometriosis groups and between eutopic and ectopic endometrium in endometriosis group. | through study completion, an average of 18 months |
| Change in histological tissue structure | Comparing changes in histological tissue structure (thickness of the endometrium expressed in micrometer) in the model of complex endometrial tissue generated ex vivo by tissue bioengineering (eutopic endometrium) in each donor, between control and endometriosis groups and between eutopic and ectopic endometrium in endometriosis group. | through study completion, an average of 18 months |
| Change in tissue elasticity | Comparing changes in tissue elasticity by assessing the speed of shear waves in the model of complex endometrial tissue generated ex vivo by tissue bioengineering (eutopic endometrium) in each donor, between control and endometriosis groups and between eutopic and ectopic endometrium in endometriosis group. | through study completion, an average of 18 months |
| Change in steroid hormone physiology | Measurement of steroid hormones concentration levels in blood and comparison between control and endometriosis groups. Steroid hormones assays will be carried out using ELISA® technologies. The following hormones will be measured: prolactin, Luteinizing Hormone (LH), estradiol (E2), estrone, progesterone and Sex hormone-binding globulin SHBG. The unit of measurement is pg/ml for all hormones. | At baseline |
| Steroid hormones in peritoneal fluid | Measurement of steroid hormones concentration levels in peritoneal fluid and comparison between control and endometriosis groups. Steroid hormones assays will be carried out using ELISA® technologies. The following hormones will be measured: prolactin, Luteinizing Hormone (LH), estradiol (E2), estrone, progesterone and Sex hormone-binding globulin SHBG. The unit of measurement is pg/ml for all hormones. | At baseline |
| Hôpital de la Croix-Rousse / GHN | Recruiting | Lyon | 69004 | France |
|
| D000091662 | Genital Diseases |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |