NCT05339451Recruiting
Blood and Tissue Markers for Improving Diagnosis and Prognosis of Endometriosis. (ENDOBIO)
Blood and Tissue Markers for Improving Diagnosis and Prognosis of Endometriosis. a Prospective Multicenter Nationwide Study. (ENDOBIO)
Source: ClinicalTrials.gov · Last updated 24 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 345 (estimated)
- First submitted
- 5 Apr 2022
- Start date
- 4 May 2023
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Region Stockholm
- Diseases
- Endometriosis
- NCT number
- NCT05339451
What you commit to
- Study type: Observational
- Planned participants: 345
- From 4 May 2023 to the primary completion date, 31 Dec 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- corticosteroids in the last 3 months
Other illness
- premature ovarian failure
- pelvic inflammatory disease (PID)
- current or previous malignancy
- pituitary, kidney, liver, adrenal disease
- cardiovascular or systemic inflammatory diseases.
Other
- BMI\> 40
- postmenopausal women
- pregnancy and 6 months postpartum
- endometrial hyperplasia or endometrial polyp
Criteria the registry did not label
- 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.
Age in the registry: 18 years to 45 years · Sex: Female · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Karolinska Universitetssjukhus Huddinge Coordinator of this site? Confirm its status | Stockholm | Sweden | Recruiting |
| Södersjukhuset Kvinnokliniken Coordinator of this site? Confirm its status | Stockholm | Sweden | Recruiting |
| Akademiska Uppsala Coordinator of this site? Confirm its status | Uppsala | Sweden | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.