RecruitingNCT05339451

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)


Sponsor

Region Stockholm

Enrollment

345 participants

Start Date

May 4, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria3

  • 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 Criteria10

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTBlood biomarkers

Blood biomarkers in plasma and serum.


Locations(3)

Karolinska Universitetssjukhus Huddinge

Stockholm, Huddinge, Sweden

Södersjukhuset Kvinnokliniken

Stockholm, Stockholm County, Sweden

Akademiska Uppsala

Uppsala, Sweden

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05339451


Related Trials