Innovative Non-Invasive Diagnostics and Personalized Treatment Strategies for Endometriosis Through Advanced Multi-Omics and Ultrasound Integration (ENDO-NOVA)
Innovativa Icke-invasiva Diagnostiska Och Personliga Behandlingsstrategier för Endometrios Genom Avancerad Multi-omik Och Ultraljudsintegration
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:
- AI-enhanced TVUS for improved lesion detection.
- Multi-omics biomarker discovery through proteomics, transcriptomics, and immune profiling.
- Underpinning the mechanisms of reduced endometrial receptivity in endometriosis using an in vitro model of embryo-endometrium interaction.
- 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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Stefhanie Romero Andersson, MD, PhD, MSc
- Numer telefonu: 0046707822742
- E-mail: stefhanie.romero.andersson@ki.se
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
Inclusion Criteria:
- Women aged 18-45
- Understands and speaks the Swedish language
- Suspected or confirmed endometriosis
Exclusion Criteria:
- Do not have a uterus
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
1
Never had treatment
|
Diagnosis using AI-enhanced transvaginal ultrasound, multi-omics, and organoids
|
|
2
Ongoing treatment
|
Diagnosis using AI-enhanced transvaginal ultrasound, multi-omics, and organoids
|
|
3
No actual treatment (has had treatment before)
|
Diagnosis using AI-enhanced transvaginal ultrasound, multi-omics, and organoids
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Diagnostic accuracy of the combined AI-assisted transvaginal ultrasound and multi-omics biomarker model for detection of endometriosis
Ramy czasowe: At baseline diagnostic evaluation
|
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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Diagnostic accuracy of AI-assisted transvaginal ultrasound alone
Ramy czasowe: Baseline
|
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
Ramy czasowe: Baseline sample collection
|
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
Ramy czasowe: Periprocedural/ During in vitro culture period (e.g., up to 5-10 days)
|
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
Ramy czasowe: Periprocedural/During in vitro experiments
|
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
Ramy czasowe: At baseline sample collection and through study completion (around 3 years)
|
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)
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Krzesło do nauki: Ronak Perot, MD, Region Stockholm
- Krzesło do nauki: Lars Henningsohn, MD,Prof, Karolinska Institutet
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- DNR 2025-03336-01
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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