Blood and Tissue Markers for Improving Diagnosis and Prognosis of Endometriosis. (ENDOBIO)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood biomarkers.
- Who it may be relevant to
- Registry conditions: Endometriosis. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Blood and Tissue Markers for Improving Diagnosis and Prognosis of Endometriosis. a Prospective Multicenter Nationwide Study. (ENDOBIO)
Overview
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 test Blood biomarkers
Blood biomarkers in plasma and serum.
Primary outcome measures
- Measurement of blood biomarkers panel for the diagnosis of endometriosis with sensitivity 94% [Time frame: Preoperative]
- Change in blood biomarkers levels 3-6 months postoperative in patients with severe endometriosis. [Time frame: 3-6 months postoperative in the severe/DIE group]
- Measurement of blood biomarkers panel for the diagnosis of endometriosis with specificity 79% [Time frame: Preoperative]
Secondary outcome measures (2)
- Quality of life of patients undergoing surgery for DIE [Time frame: Preoperative and 3-6 months postoperative in the severe/DIE group]
- Achieved pregnancy postoperative [Time frame: One year postoperative]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Sweden · 3 centers
- Karolinska Universitetssjukhus Huddinge — Stockholm
- Södersjukhuset Kvinnokliniken — Stockholm
- Akademiska Uppsala — Uppsala
Identifiers
NCT: NCT05339451 · K 2022-2797