Blood and Tissue Markers for Improving Diagnosis and Prognosis of Endometriosis. (ENDOBIO)
- Conditions
- Endometriosis
- Interventions
- Diagnostic Test: Blood biomarkers
- Registration Number
- NCT05339451
- Lead Sponsor
- Region Stockholm
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 345
- 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.
- BMI> 40
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Severe/Deep infiltrating endometriosis Blood biomarkers Endometriosis stage III/IV according to rASRM. Controls Blood biomarkers Women operated for other benign gynecological diseases and have no signs of endometriosis perioperatively. Minimal/mild endometriosis Blood biomarkers Endometriosis stage I/II according to rASRM
- Primary Outcome Measures
Name Time Method Measurement of blood biomarkers panel for the diagnosis of endometriosis with specificity 79% Preoperative Blood biomarkers as endometriosis diagnostic tests
Change in blood biomarkers levels 3-6 months postoperative in patients with severe endometriosis. 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% Preoperative Blood biomarkers as endometriosis diagnostic tests
- Secondary Outcome Measures
Name Time Method Achieved pregnancy postoperative One year postoperative Positive pregnancy test
Quality of life of patients undergoing surgery for DIE Preoperative and 3-6 months postoperative in the severe/DIE group Endometriosis Health Profile 30 Questionnaire
Trial Locations
- Locations (3)
Karolinska Universitetssjukhus Huddinge
🇸🇪Stockholm, Huddinge, Sweden
Södersjukhuset Kvinnokliniken
🇸🇪Stockholm, Sweden
Akademiska Uppsala
🇸🇪Uppsala, Sweden