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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorRegion Stockholm

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women aged 18-45

Understands and speaks the Swedish language

Suspected or confirmed endometriosis

Disqualifiers

Do not have a uterus

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Non-invasive diagnosis of endometriosis

    Diagnostic test

    Diagnosis using AI-enhanced transvaginal ultrasound, multi-omics, and organoids

Treatment groups

365 Participants
are divided into 3 treatment groups
Group A: 11 intervention
Group B: 21 intervention
Group C: 31 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At baseline diagnostic evaluation

Secondary outcomes

1

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.

Time frame
Baseline
2

Diagnostic performance of plasma and endometrial biomarker panel

To assess the ability of plasma and endometrial-derived biomarkers to detect endometriosis, disease stage, and correlate to clinical symptoms.

Time frame
Baseline sample collection
3

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.

Time frame
Periprocedural/ During in vitro culture period (e.g., up to 5-10 days)
4

Molecular characteristics associated with embryo/blastoid attachment

To evaluate transcriptomic and hormonal differences between successfully and unsuccessfully attaching embryos or blastoids.

Time frame
Periprocedural/During in vitro experiments

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Region Stockholm

Lead sponsor

Karolinska Institutet

Collaborator

This trial is not recruiting at the moment. You can still explore other options: