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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
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Endometriosis is a prevalent gynecological condition affecting approximately 10% of women of reproductive age worldwide. It presents with nonspecific but often severe symptoms, including chronic pelvic pain (in 70% of cases) and infertility (in up to 40% of cases), imposing significant physical, psychological, economic, and societal burdens. Despite its widespread occurrence, the exact etiology and pathogenesis of endometriosis remain unclear, and no definitive cure exists. Early diagnosis and management are crucial for improving patient outcomes; however, major diagnostic delays persist. Current imaging techniques such as transvaginal ultrasound (TVUS) examination and magnetic resonance imaging, along with biochemical markers lack sufficient specificity. Consequently, confirmation of diagnosis still requires surgical procedures under general anesthesia, i.e.
laparoscopy ("key-hole surgery") and tissue biopsy. This delay exacerbates the disease burden and healthcare costs, underscoring the urgent need for non-invasive, precise diagnostic strategies. This project proposes a multi-modal approach integrating advanced ultrasound imaging with novel biomarkers identified via comprehensive multi-omics analyses, including proteomics, transcriptomics, and immune profiling, of patient-derived endometrial organoids. It aims to understand the underlying mechanisms of reduced endometrial receptivity of embryos in patients with endometriosis. Additionally, we will explore personalized treatment strategies by utilizing patient-specific organoids for drug screening and evaluation of treatment response.
This project aims to develop a non-invasive diagnostic strategy by integrating:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Never had treatment |
| |
| 2 | Ongoing treatment |
| |
| 3 | No actual treatment (has had treatment before) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive diagnosis of endometriosis | Diagnostic Test | Diagnosis using AI-enhanced transvaginal ultrasound, multi-omics, and organoids |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of the combined AI-assisted transvaginal ultrasound and multi-omics biomarker model for detection of endometriosis | Sensitivity and specificity of a combined diagnostic model integrating AI-assisted interpretation of transvaginal ultrasound images with plasma, saliva, urine, and endometrial-derived biomarkers for the detection of endometriosis, using laparoscopic diagnosis with or without histological confirmation as the reference standard. | At baseline diagnostic evaluation |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of AI-assisted transvaginal ultrasound alone | To evaluate the performance of AI-assisted transvaginal ultrasound (TVUS) for detection and classification of endometriosis lesions. | Baseline |
| Diagnostic performance of plasma and endometrial biomarker panel |
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Inclusion Criteria:
Exclusion Criteria:
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Only women of people who have a uterus are eligible
Women aged 18-45 years with suspected or confirmed endometriosis that visit the Endometriosis Centre at the Gynaecology Department at Karolinska University Hospital (KUS), Huddinge
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefhanie Romero Andersson, MD, PhD, MSc | Contact | 0046707822742 | stefhanie.romero.andersson@ki.se |
| Name | Affiliation | Role |
|---|---|---|
| Ronak Perot, MD | Region Stockholm | Study Chair |
| Lars Henningsohn, MD,Prof | Karolinska Institutet | Study Chair |
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Blood, endometrium, saliva, urine, ascites, peritoneum, embryos
To assess the ability of plasma and endometrial-derived biomarkers to detect endometriosis, disease stage, and correlate to clinical symptoms. |
| Baseline sample collection |
| Implantation rate in in vitro endometrial models | To compare the attachment rate of embryo-derived or stem cell-derived embryonic structures (blastoids) to endometrial tissue from women with and without endometriosis. | Periprocedural/ During in vitro culture period (e.g., up to 5-10 days) |
| Molecular characteristics associated with embryo/blastoid attachment | To evaluate transcriptomic and hormonal differences between successfully and unsuccessfully attaching embryos or blastoids. | Periprocedural/During in vitro experiments |
| Organoid drug response variability and association with disease characteristics | To evaluate variability in response to hormonal and immune-targeted therapies in organoids and association with disease severity. | At baseline sample collection and through study completion (around 3 years) |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D007246 | Infertility |
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