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

Blood and Tissue Markers for Improving Diagnosis and Prognosis of Endometriosis. a Prospective Multicenter Nationwide Study. (ENDOBIO)

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.

Study Overview

• Status: Recruiting
• Conditions: Endometriosis
• Intervention / Treatment: Diagnostic test: Blood biomarkers

• Study Type: Observational
• Enrollment (Estimated): 345

Contacts and Locations

• Study Contact: Name: Anastasia Drakou, MSc; Phone Number: 0046 735500118; Email: anastasia.drakou@regionstockholm.se
• Study Contact Backup: Name: Kenny Rodriguez-Wallberg, Professor; Email: kenny.rodriguez-wallberg@ki.se

Study Locations

• Sweden
  • Stockholm, Sweden
    • Recruiting
    • Södersjukhuset Kvinnokliniken
    • Contact: Malin Brunes, PhD
  • Uppsala, Sweden
    • Not yet recruiting
    • Akademiska Uppsala
    • Contact: Christine Asciutto, PhD
  • Huddinge
    • Stockholm, Huddinge, Sweden
      • Recruiting
      • Karolinska Universitetssjukhus Huddinge
      • Contact: Anastasia Drakou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Participants will be recruited in several gynecological clinics around Sweden. A total of 345 women of reproductive age will be included in the study according to the power calculation. 115 patients who are operated on due to deep infiltrating endometriosis or rASRM III-IV in national endometriosis centers in Sweden, 115 patients who are diagnosed during surgery with early-stage endometriosis (rASRM I-II) and 115 patients who are controls, who are operated on for others benign gynecological diseases (fibroids, ovarian cysts, chronic abdominal pain, sterilization) and have no signs of endometriosis perioperatively.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Severe/Deep infiltrating endometriosis; Endometriosis stage III/IV according to rASRM.	Diagnostic test: Blood biomarkers; Blood biomarkers in plasma and serum.
Minimal/mild endometriosis; Endometriosis stage I/II according to rASRM	Diagnostic test: Blood biomarkers; Blood biomarkers in plasma and serum.
Controls; Women operated for other benign gynecological diseases and have no signs of endometriosis perioperatively.	Diagnostic test: Blood biomarkers; Blood biomarkers in plasma and serum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of blood biomarkers panel for the diagnosis of endometriosis with sensitivity 94%	Blood biomarkers as endometriosis diagnostic tests	Preoperative
Change in blood biomarkers levels 3-6 months postoperative in patients with severe endometriosis.	Blood biomarkers as a relapse marker	3-6 months postoperative in the severe/DIE group
Measurement of blood biomarkers panel for the diagnosis of endometriosis with specificity 79%	Blood biomarkers as endometriosis diagnostic tests	Preoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life of patients undergoing surgery for DIE	Endometriosis Health Profile 30 Questionnaire	Preoperative and 3-6 months postoperative in the severe/DIE group
Achieved pregnancy postoperative	Positive pregnancy test	One year postoperative

Collaborators and Investigators

• Sponsor: Region Stockholm
• Collaborators: Karolinska Institutet; Akademiska University Hospital, Uppsala, Sweden; Södersjukhuset (Stockholm South General Hospital)
• Investigators: Principal Investigator: Kenny Rodriguez-Wallberg, Professor, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 5, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: biomarkers; endometriosis
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endometriosis
• Other Study ID Numbers: K 2022-2797

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No