Innovativa Icke-invasiva Diagnostiska Och Personliga Behandlingsstrategier för Endometrios Genom Avancerad Multi-omik Och Ultraljudsintegration
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 365
- 主要终点
- Diagnostic accuracy of the combined AI-assisted transvaginal ultrasound and multi-omics biomarker model for detection of endometriosis
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-45
- •Understands and speaks the Swedish language
- •Suspected or confirmed endometriosis
排除标准
- •Do not have a uterus
研究组 & 干预措施
3
No actual treatment (has had treatment before)
干预措施: Non-invasive diagnosis of endometriosis (Diagnostic Test)
1
Never had treatment
干预措施: Non-invasive diagnosis of endometriosis (Diagnostic Test)
2
Ongoing treatment
干预措施: Non-invasive diagnosis of endometriosis (Diagnostic Test)
结局指标
主要结局
Diagnostic accuracy of the combined AI-assisted transvaginal ultrasound and multi-omics biomarker model for detection of endometriosis
时间窗: 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.
次要结局
- 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))