Non-invasive diagnosis of endometriosis
Diagnostic TestDiagnosis using AI-enhanced transvaginal ultrasound, multi-omics, and organoids
NCT Number: NCT07570225
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.
Trial opening soon.
Get Notified18 year–45 year
Female
Observational
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Diagnosis using AI-enhanced transvaginal ultrasound, multi-omics, and organoids
Time frame: 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.
Time frame: Baseline
To evaluate the performance of AI-assisted transvaginal ultrasound (TVUS) for detection and classification of endometriosis lesions.
Time frame: Baseline sample collection
To assess the ability of plasma and endometrial-derived biomarkers to detect endometriosis, disease stage, and correlate to clinical symptoms.
Time frame: 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.
Time frame: Periprocedural/During in vitro experiments
To evaluate transcriptomic and hormonal differences between successfully and unsuccessfully attaching embryos or blastoids.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Region Stockholm
Other Gov
Innovativa Icke-invasiva Diagnostiska Och Personliga Behandlingsstrategier för Endometrios Genom Avancerad Multi-omik Och Ultraljudsintegration
Acronym: ENDO-NOVA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07265505
Abortion, Habitual, Abortion, Spontaneous
Paris, IDF, France
View Trial DetailsNCT04356664
Adenomyosis, Endometriosis
Suresnes, France
View Trial DetailsNCT04166825
Cardiovascular Diseases, Embolism and Thrombosis
Krakow, Małopolska, Poland
View Trial DetailsNCT06560814
Endometriosis, Female Urogenital Diseases
Dhaka, Bangladesh
View Trial Details