Blood and Tissue Markers for Improving Diagnosis and Prognosis of Endometriosis. (ENDOBIO)

Study Overview
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Brief Summary
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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.

Official Title
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Blood and Tissue Markers for Improving Diagnosis and Prognosis of Endometriosis. A Prospective Multicenter Nationwide Study. (ENDOBIO)

Conditions
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Endometriosis

Intervention / Treatment
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* Diagnostic Test: Blood biomarkers


Participation Criteria
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Eligibility Criteria
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IInclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Severe/Deep infiltrating endometriosis<br>Endometriosis stage III/IV according to rASRM. | Diagnostic Test: Blood biomarkers<br>* Blood biomarkers in plasma and serum.<br>|
| Minimal/mild endometriosis<br>Endometriosis stage I/II according to rASRM | Diagnostic Test: Blood biomarkers<br>* Blood biomarkers in plasma and serum.<br>|
| Controls<br>Women operated for other benign gynecological diseases and have no signs of endometriosis perioperatively. | Diagnostic Test: Blood biomarkers<br>* Blood biomarkers in plasma and serum.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of blood biomarkers panel for the diagnosis of endometriosis with sensitivity 94% | Blood biomarkers as endometriosis diagnostic tests | Preoperative | 
| Change in blood biomarkers levels 3-6 months postoperative in patients with severe endometriosis. | Blood biomarkers as a relapse marker | 3-6 months postoperative in the severe/DIE group | 
| Measurement of blood biomarkers panel for the diagnosis of endometriosis with specificity 79% | Blood biomarkers as endometriosis diagnostic tests | Preoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life of patients undergoing surgery for DIE | Endometriosis Health Profile 30 Questionnaire | Preoperative and 3-6 months postoperative in the severe/DIE group | 
| Achieved pregnancy postoperative | Positive pregnancy test | One year postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometriosis, biomarkers