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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Stefhanie Romero Andersson, MD, PhD, MSc
- Número de teléfono: 0046707822742
- Correo electrónico: stefhanie.romero.andersson@ki.se
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Women aged 18-45
- Understands and speaks the Swedish language
- Suspected or confirmed endometriosis
Exclusion Criteria:
- Do not have a uterus
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Diagnostic accuracy of the combined AI-assisted transvaginal ultrasound and multi-omics biomarker model for detection of endometriosis
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Diagnostic accuracy of AI-assisted transvaginal ultrasound alone
Periodo de tiempo: Baseline
|
To evaluate the performance of AI-assisted transvaginal ultrasound (TVUS) for detection and classification of endometriosis lesions.
|
Baseline
|
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Diagnostic performance of plasma and endometrial biomarker panel
Periodo de tiempo: Baseline sample collection
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To assess the ability of plasma and endometrial-derived biomarkers to detect endometriosis, disease stage, and correlate to clinical symptoms.
|
Baseline sample collection
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Implantation rate in in vitro endometrial models
Periodo de tiempo: Periprocedural/ During in vitro culture period (e.g., up to 5-10 days)
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To compare the attachment rate of embryo-derived or stem cell-derived embryonic structures (blastoids) to endometrial tissue from women with and without endometriosis.
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Periprocedural/ During in vitro culture period (e.g., up to 5-10 days)
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Molecular characteristics associated with embryo/blastoid attachment
Periodo de tiempo: Periprocedural/During in vitro experiments
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To evaluate transcriptomic and hormonal differences between successfully and unsuccessfully attaching embryos or blastoids.
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Periprocedural/During in vitro experiments
|
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Organoid drug response variability and association with disease characteristics
Periodo de tiempo: 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.
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At baseline sample collection and through study completion (around 3 years)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Ronak Perot, MD, Region Stockholm
- Silla de estudio: Lars Henningsohn, MD,Prof, Karolinska Institutet
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- DNR 2025-03336-01
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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