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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Sweden
Karolinska Universitetssjukhus Huddinge
RECRUITING
Stockholm
Södersjukhuset Kvinnokliniken
RECRUITING
Stockholm
Akademiska Uppsala
NOT_YET_RECRUITING
Uppsala
Contact Information
Primary
Anastasia Drakou, MSc
anastasia.drakou@regionstockholm.se
0046 735500118
Backup
Kenny Rodriguez-Wallberg, Professor
kenny.rodriguez-wallberg@ki.se
Time Frame
Start Date: 2023-05-04
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 345
Treatments
Severe/Deep infiltrating endometriosis
Endometriosis stage III/IV according to rASRM.
Minimal/mild endometriosis
Endometriosis stage I/II according to rASRM
Controls
Women operated for other benign gynecological diseases and have no signs of endometriosis perioperatively.
Related Therapeutic Areas
Sponsors
Collaborators: Södersjukhuset (Stockholm South General Hospital), Karolinska Institutet, Akademiska University Hospital, Uppsala, Sweden
Leads: Region Stockholm

This content was sourced from clinicaltrials.gov