Innovative Non-Invasive Diagnostics and Personalized Treatment Strategies for Endometriosis Through Advanced Multi-Omics and Ultrasound Integration

Официальное название

Innovativa Icke-invasiva Diagnostiska Och Personliga Behandlingsstrategier för Endometrios Genom Avancerad Multi-omik Och Ultraljudsintegration

Обзор

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: 1. AI-enhanced TVUS for improved lesion detection. 2. Multi-omics biomarker discovery through proteomics, transcriptomics, and immune profiling. 3. Underpinning the mechanisms of reduced endometrial receptivity in endometriosis using an in vitro model of embryo-endometrium interaction. 4. Endometrial organoid models to enable precision medicine-based drug testing. The development of a reliable noninvasive or minimally invasive diagnostic test-or a combination of tests-could revolutionize the diagnostic pathway by reducing delays, avoiding the need for surgery, and facilitating disease monitoring and treatment evaluation.

Вмешательства

• Диагностический тест Non-invasive diagnosis of endometriosis
  Diagnosis using AI-enhanced transvaginal ultrasound, multi-omics, and organoids

Первичные конечные точки

• Diagnostic accuracy of the combined AI-assisted transvaginal ultrasound and multi-omics biomarker model for detection of endometriosis [Срок оценки: At baseline diagnostic evaluation]

Вторичные конечные точки (5)

• Diagnostic accuracy of AI-assisted transvaginal ultrasound alone [Срок оценки: Baseline]
• Diagnostic performance of plasma and endometrial biomarker panel [Срок оценки: Baseline sample collection]
• Implantation rate in in vitro endometrial models [Срок оценки: Periprocedural/ During in vitro culture period (e.g., up to 5-10 days)]
• Molecular characteristics associated with embryo/blastoid attachment [Срок оценки: Periprocedural/During in vitro experiments]
• Organoid drug response variability and association with disease characteristics [Срок оценки: At baseline sample collection and through study completion (around 3 years)]

Критерии участия

Критерии включения

• Women aged 18-45
• Understands and speaks the Swedish language
• Suspected or confirmed endometriosis

Критерии исключения

• Do not have a uterus

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07570225 · DNR 2025-03336-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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