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

Endometriosis Clinical Trial

— ENDOBIO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05339451
• Other study ID #: K 2022-2797
• Status: Recruiting
• Start date: May 4, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: October 2023
• Source: Region Stockholm
• Contact: Anastasia Drakou, MSc
• Phone: 0046 735500118
• Email: anastasia.drakou[@]regionstockholm.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 345
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis

Intervention

Diagnostic Test:
• Blood biomarkers
Blood biomarkers in plasma and serum.

Locations

Country	Name	City	State
Sweden	Karolinska Universitetssjukhus Huddinge	Stockholm	Huddinge
Sweden	Södersjukhuset Kvinnokliniken	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Region Stockholm	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of blood biomarkers panel for the diagnosis of endometriosis with sensitivity 94%	Blood biomarkers as endometriosis diagnostic tests	Preoperative
Primary	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
Primary	Measurement of blood biomarkers panel for the diagnosis of endometriosis with specificity 79%	Blood biomarkers as endometriosis diagnostic tests	Preoperative
Secondary	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
Secondary	Achieved pregnancy postoperative	Positive pregnancy test	One year postoperative