Investigating blood and tissue markers for diagnosing endometriosis
Blood and Tissue Markers for Improving Diagnosis and Prognosis of Endometriosis. a Prospective Multicenter Nationwide Study. (ENDOBIO)
This study is trying to find blood and tissue markers that can help doctors diagnose endometriosis earlier and more accurately in women who are having surgery for suspected cases.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 345 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Region Stockholm Government |
| Locations | 3 sites (Stockholm, Huddinge and 2 other locations) |
| Trial ID | NCT05339451 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify and validate biomarkers associated with endometriosis to improve diagnosis and prognosis. It will involve women of reproductive age who are undergoing laparoscopic surgery for suspected endometriosis or other benign gynecological conditions. The study will analyze blood and tissue samples to correlate these biomarkers with clinical manifestations, relapse rates, and fertility outcomes. The goal is to develop a laboratory test that can facilitate earlier and more accurate diagnosis of endometriosis.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-45 who are undergoing surgery for suspected endometriosis or other benign gynecological issues.
Not a fit: Patients who are postmenopausal, have a BMI over 40, or have certain other medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and better management of endometriosis, reducing the time patients suffer before receiving appropriate care.
How similar studies have performed: While there have been studies exploring biomarkers in endometriosis, this specific approach to validate them for diagnosis and prognosis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Stockholm, Huddinge and 2 other locations
- Karolinska Universitetssjukhus Huddinge — Stockholm, Huddinge, Sweden (Recruiting)
- Södersjukhuset Kvinnokliniken — Stockholm, Stockholm County, Sweden (Recruiting)
- Akademiska Uppsala — Uppsala, Sweden (Not_yet_recruiting)
Study contacts
- Principal investigator: Kenny Rodriguez-Wallberg, Professor — Karolinska Institutet
- Study coordinator: Anastasia Drakou, MSc
- Email: anastasia.drakou@regionstockholm.se
- Phone: 0046 735500118
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.