Endometriosis
Conditions
Keywords
endometriosis, biomarkers
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.
Interventions
DIAGNOSTIC_TESTBlood biomarkers
Blood biomarkers in plasma and serum.
Sponsors
Karolinska Institutet
Södersjukhuset (Stockholm South General Hospital)
Akademiska University Hospital, Uppsala, Sweden
Region Stockholm
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of blood biomarkers panel for the diagnosis of endometriosis with sensitivity 94% | 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 specificity 79% | Preoperative | Blood biomarkers as endometriosis diagnostic tests |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Achieved pregnancy postoperative | One year postoperative | Positive pregnancy test |
Countries
Sweden
Contacts
Primary ContactAnastasia Drakou, MSc
Backup ContactKenny Rodriguez-Wallberg, Professor
Outcome results
None listed