Blood and Tissue Markers for Improving Diagnosis and Prognosis of Endometriosis. a Prospective Multicenter Nationwide Study. (ENDOBIO)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 345
- 试验地点
- 3
- 主要终点
- Measurement of blood biomarkers panel for the diagnosis of endometriosis with specificity 79%
研究概览
简要总结
Endometriosis is a chronic, benign, estrogen-dependent disease characterized by endometrial tissue that is implanted outside the uterus into the ovaries, intestines, or peritoneum but also outside the pelvis. It is a common disease that affects 7-10% of women around the world. The most common symptoms are pain and infertility. The diagnosis is histological after removal of lesions with laparoscopy (sensitivity 94%, specificity 79%), and treatment is symptomatic.
At present, there is not a laboratory test that allows early and adequate diagnosis of endometriosis and therefore it can take up to 10 years for a patient to be diagnosed and patients often suffer from the disease.
The purpose of our study is to investigate biomarkers associated with endometriosis and prove their use in the diagnosis and staging of endometriosis. The biomarkers will be studied even in relationship to clinical manifestations of the disease, as markers of relapse and as fertility markers. Meanwhile, quality of life of patients with advanced stages of endometriosis postoperatively will be studied.
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
- 是
入选标准
- •women of reproductive age (18-45) who are operated because of suspected endometriosis (dysmenorrhea, dyspareunia, infertility, etc.) (patient group)
- •women of reproductive age (18-45) who are operated for other benign gynecological causes with laparoscopy (ovarian cysts, sterilization, fibroids, etc.) and are found without macroscopic endometriosis perioperatively and confirmed with blind biopsies (control group
- •talk swedish or english in order to complete questionnaires and give informed consent for their participation in the study.
排除标准
- •postmenopausal women
- •premature ovarian failure
- •pelvic inflammatory disease (PID)
- •current or previous malignancy
- •pregnancy and 6 months postpartum
- •corticosteroids in the last 3 months
- •pituitary, kidney, liver, adrenal disease
- •endometrial hyperplasia or endometrial polyp
- •cardiovascular or systemic inflammatory diseases.
结局指标
主要结局
Measurement of blood biomarkers panel for the diagnosis of endometriosis with specificity 79%
时间窗: Preoperative
Blood biomarkers as endometriosis diagnostic tests
Change in blood biomarkers levels 3-6 months postoperative in patients with severe endometriosis.
时间窗: 3-6 months postoperative in the severe/DIE group
Blood biomarkers as a relapse marker
Measurement of blood biomarkers panel for the diagnosis of endometriosis with sensitivity 94%
时间窗: Preoperative
Blood biomarkers as endometriosis diagnostic tests
次要结局
- Achieved pregnancy postoperative(One year postoperative)
- Quality of life of patients undergoing surgery for DIE(Preoperative and 3-6 months postoperative in the severe/DIE group)