Actively Recruiting

Age: 18Years - 45Years
FEMALE
Healthy Volunteers
NCT05339451

Blood and Tissue Markers for Improving Diagnosis and Prognosis of Endometriosis. (ENDOBIO)

Led by Region Stockholm · Updated on 2025-02-24

345

Participants Needed

3

Research Sites

191 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, 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.

CONDITIONS

Official Title

Blood and Tissue Markers for Improving Diagnosis and Prognosis of Endometriosis. (ENDOBIO)

Who Can Participate

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 to 45 years
  • Undergoing surgery due to suspected endometriosis symptoms such as pain or infertility (patient group)
  • Undergoing surgery for other benign gynecological reasons without visible endometriosis confirmed by biopsies (control group)
  • Able to speak Swedish or English to complete questionnaires and provide informed consent
Not Eligible

You will not qualify if you...

  • Body mass index over 40
  • Postmenopausal women
  • Premature ovarian failure
  • Pelvic inflammatory disease
  • 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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

A

Anastasia Drakou, MSc

CONTACT

K

Kenny Rodriguez-Wallberg, Professor

CONTACT

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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