Validation of Specific Biomarkers for the Diagnosis of Endometriosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 975
- 试验地点
- 2
- 主要终点
- Sensibility for endometriosis diagnosis (probability of detection)
研究概览
简要总结
EndoSearch aims to analytically validate a cluster of specific biomarkers for endometriosis diagnosis and disease recurrence. This signature will be tested on endometrium and blood from 975 patients, divided in two groups : 550 patients affected by endometriosis and 225 patients unaffected (controls).
EndoSearch is not about drug or medical device assessment but a research study for biomarker analytical validation purpose.
详细描述
Endometriosis is a very common gynecological disease affecting 10% of women of reproductive age. Main symptoms are chronic and severe pain in pelvis area and infertility in up to 40% of affected women. Currently, the only method to obtain a reliable diagnosis is the analysis of endometriotic lesions removed during surgery under general anaesthesia. There is a real need to diagnosis endometriosis non-invasively and quickly in order to improve patient management.
EndoSearch aims to analytically validate a cluster of endometrial and blood biomarkers identified in previous studies and specific for the endometriosis diagnosis and disease prognosis recurrence. During 2 years (follow up period) and 9 months (inclusion period), 15 clinical centers worldwide will recruit patients and collect biological samples and personal and clinical data from these patients. The biological samples will be processed at Endodiag labs, Paris, France though lab biotechnology techniques. Results will allow the assessment of sensibility and specificity (NPV and PPV) of the biomarker signature for endometriosis diagnosis and disease recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •for endometriosis patients :
- •Woman, from 18 to 45
- •Patients with endometriosis suspicion, associated adenomyosis is accepted
- •Freely signature of the consent form
- •Patient needs laparoscopy for endometriosis purpose (first intervention or recurrence) regardless of the endometriosis type (superficial, ovarian or deep)
- •Possibility of follow up during 2 years.
- •Inclusion Criteria for Healthy voluntary patients:
- •Woman 18 to 45
- •Freely signature of the consent form
- •Patient needs laparoscopy for another indication than endometriosis, adenomyosis, uterine fibroma & other fibroid pathologies (ex of surgeries: tubular sterilization, ovarian non-fibroid cyst, urinary incontinence requiring ureteral intervention).
排除标准
- •for endometriosis patients :
- •Refusal or linguistic or psychic incapacity to sign informed consent
- •No internet access or refusal to use new technologies
- •Minor woman (under 18 years old)
- •Pregnancy or breastfeeding
- •Menopause
- •Evidence of adenomyosis without endometriosis
- •All metabolic pathology, endocrine, chronical infectious or malignant.
- •Endometriosis negative result at visual and histological examination by anatomopathologist of the clinical centre.
- •Exclusion Criteria for Healthy voluntary patients
- •Refusal or linguistic or psychic incapacity to sign informed consent
- •No internet access or refusal to use new technologies
- •Minor woman (under 18 years old)
- •Pregnancy or breastfeeding
- •Menopause
- •Adenomyosis
- •All metabolic pathology, endocrine, chronical infectious or malignant.
- •Endometriosis positive result at visual and histological examination by anatomopathologist of the clinical centre.
结局指标
主要结局
Sensibility for endometriosis diagnosis (probability of detection)
时间窗: Comparison between diagnosis lab result and anatomopathologist diagnosis at the end of inclusion phase (9 months after 1st patient inclusion)
Measurement of the proportion of positives patient that are correctly identified as such for the endometriosis diagnosis.
Specificity for endometriosis diagnosis
时间窗: Comparison between diagnosis lab result and anatomopathologist diagnosis at the end of inclusion phase (9 months after 1st patient inclusion)
Measurement of the proportion of negatives patient that are correctly identified as such for the endometriosis diagnosis
次要结局
- Specificity for endometriosis recurrence prognostic(Comparison between recurrence lab result and eCRF data on recurrence at the end of study (2 years and 9 months))
- Sensibility for endometriosis recurrence prognostic (probability of detection)(Comparison between recurrence lab result and eCRF data on recurrence at the end of study (2 years and 9 months))
研究者
Dr Afchine Fazel
MD PhD
Endodiag