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

Region Stockholm

Status: Enrolling

Conditions: Endometriosis

Treatments: Diagnostic Test: Blood biomarkers

Study type: Observational

Funder types: Other

Identifiers

NCT05339451

K 2022-2797

Details and patient eligibility

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.

Enrollment: 345 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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.

Trial design

345 participants in 3 patient groups

Severe/Deep infiltrating endometriosis

Description:

Endometriosis stage III/IV according to rASRM.

Treatment:

Diagnostic Test: Blood biomarkers

Minimal/mild endometriosis

Description:

Endometriosis stage I/II according to rASRM

Treatment:

Diagnostic Test: Blood biomarkers

Controls

Description:

Women operated for other benign gynecological diseases and have no signs of endometriosis perioperatively.

Treatment:

Diagnostic Test: Blood biomarkers