Actively Recruiting
Blood and Tissue Markers for Improving Diagnosis and Prognosis of Endometriosis a Prospective Multicenter Nationwide Study (ENDOBIO)
Led by Region Stockholm · Updated on 2025-02-24
345
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
Sponsors
R
Region Stockholm
Lead Sponsor
K
Karolinska Institutet
Collaborating Sponsor
AI-Summary
What this Trial Is About
Endometriosis is a chronic, non-cancerous, estrogen-dependent condition where tissue similar to the lining inside the uterus grows outside it, affecting areas like the ovaries, intestines, or other pelvic and non-pelvic sites. It commonly causes pain and infertility and affects 7-10% of women worldwide. Diagnosis usually requires tissue removal and examination via laparoscopy. This study aims to investigate blood and tissue biomarkers to improve diagnosis, staging, and prediction of relapse and fertility outcomes, while also assessing quality of life after surgery for advanced disease stages. The study observes women aged 18 to 45 who undergo surgery for suspected endometriosis or other benign gynecological conditions without endometriosis. Participants are grouped by endometriosis severity or as controls without the disease. Blood biomarkers in plasma and serum are collected to evaluate their accuracy for diagnosis preoperatively and changes after surgery in severe cases. Quality of life and pregnancy outcomes are also monitored up to one year after surgery. Participants will have blood samples taken before surgery and again 3 to 6 months after surgery if they have severe endometriosis. Questionnaires assess quality of life before and after surgery for severe cases, and pregnancy status is followed for one year postoperatively. The study measures the sensitivity and specificity of blood biomarkers for detecting endometriosis and tracks changes over time. This observational study lasts from preoperative assessment through one year post-surgery, focusing on women’s clinical outcomes and biomarker profiles.
CONDITIONS
Brief Title
Blood and Tissue Markers for Improving Diagnosis and Prognosis of Endometriosis. (ENDOBIO)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 45 years who are undergoing surgery for suspected endometriosis (e.g., pain, infertility).
- Women aged 18 to 45 years having surgery for other benign gynecological conditions without evidence of endometriosis.
- Ability to speak Swedish or English to complete questionnaires and provide informed consent.
You will not qualify if you...
- Body mass index (BMI) greater than 40.
- Postmenopausal women.
- Premature ovarian failure.
- Pelvic inflammatory disease (PID).
- Current or previous cancer.
- Pregnancy or within 6 months postpartum.
- Use of corticosteroids in the last 3 months.
- Diseases of the pituitary, kidney, liver, or adrenal glands.
- Endometrial hyperplasia or endometrial polyps.
- Cardiovascular or systemic inflammatory diseases.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Preoperative period
Participants undergo blood tests to measure biomarkers in plasma and serum to help diagnose endometriosis.
1 visit (in-person)
Duration - Day of surgery and immediate recovery
Participants undergo surgery for suspected endometriosis or other benign gynecological conditions.
1 visit (in-person)
Duration - 3 to 6 months postoperative
Participants with severe endometriosis have follow-up visits to monitor changes in blood biomarkers and quality of life.
1 to 2 visits depending on participant group
Duration - Up to 1 year postoperative
Participants are followed up to assess pregnancy outcomes after surgery.
1 visit (in-person or remote)
Trial Site Locations
Total: 3 locations
1
Karolinska Universitetssjukhus Huddinge
Stockholm, Huddinge, Sweden
Actively Recruiting
2
Södersjukhuset Kvinnokliniken
Stockholm, Stockholm County, Sweden
Actively Recruiting
3
Akademiska Uppsala
Uppsala, Sweden
Not Yet Recruiting
Research Team
A
Anastasia Drakou, MSc
K
Kenny Rodriguez-Wallberg, Professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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