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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

345 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-04

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Endometriosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Severe/Deep infiltrating endometriosis

Endometriosis stage III/IV according to rASRM.

Blood biomarkers

Intervention Type DIAGNOSTIC_TEST

Blood biomarkers in plasma and serum.

Minimal/mild endometriosis

Endometriosis stage I/II according to rASRM

Blood biomarkers

Intervention Type DIAGNOSTIC_TEST

Blood biomarkers in plasma and serum.

Controls

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

Blood biomarkers

Intervention Type DIAGNOSTIC_TEST

Blood biomarkers in plasma and serum.

Interventions

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Blood biomarkers

Blood biomarkers in plasma and serum.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes