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ENDO-NOVA
Innovativa Icke-invasiva Diagnostiska Och Personliga Behandlingsstrategier för Endometrios Genom Avancerad Multi-omik Och Ultraljudsintegration
Sponsor study identifier
observational
365
0 countries
N/A
Study Start
April 20, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 20, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 20, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 20, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 13, 2026
Actual (reported)April 20, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 6, 2026
Actual (reported)April 20, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 20, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
At baseline diagnostic evaluation
Diagnostic accuracy of AI-assisted transvaginal ultrasound alone
Baseline
Diagnostic performance of plasma and endometrial biomarker panel
Baseline sample collection
Implantation rate in in vitro endometrial models
Periprocedural/ During in vitro culture period (e.g., up to 5-10 days)
Molecular characteristics associated with embryo/blastoid attachment
Periprocedural/During in vitro experiments
Organoid drug response variability and association with disease characteristics
At baseline sample collection and through study completion (around 3 years)
Never had treatment
Ongoing treatment
No actual treatment (has had treatment before)
Diagnosis using AI-enhanced transvaginal ultrasound, multi-omics, and organoids
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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
Blood, endometrium, saliva, urine, ascites, peritoneum, embryos
Ronak Perot, MD
Region Stockholm
Lars Henningsohn, MD,Prof
Karolinska Institutet
First Submitted
April 13, 2026
First Posted
May 6, 2026
Study Start
April 20, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 20, 2028
EstimatedContact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 20, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 6, 2026
Record last verified: 2026-04
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Source: ClinicalTrials.gov.
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