Blood and Tissue Markers for Improving Diagnosis and Prognosis of Endometriosis. (ENDOBIO)
ENDOBIO
1 other identifier
observational
345
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2023
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2022
CompletedFirst Posted
Study publicly available on registry
April 21, 2022
CompletedStudy Start
First participant enrolled
May 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedFebruary 24, 2025
February 1, 2025
2.7 years
April 5, 2022
February 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (2)
Quality of life of patients undergoing surgery for DIE
Preoperative and 3-6 months postoperative in the severe/DIE group
Achieved pregnancy postoperative
One year postoperative
Study Arms (3)
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.
Interventions
Blood biomarkers in plasma and serum.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Stockholmlead
- Karolinska Institutetcollaborator
- Södersjukhuset (Stockholm South General Hospital)collaborator
- Akademiska University Hospital, Uppsala, Swedencollaborator
Study Sites (3)
Karolinska Universitetssjukhus Huddinge
Stockholm, Huddinge, Sweden
Södersjukhuset Kvinnokliniken
Stockholm, Stockholm County, Sweden
Akademiska Uppsala
Uppsala, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenny Rodriguez-Wallberg, Professor
Karolinska Institutet
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2022
First Posted
April 21, 2022
Study Start
May 4, 2023
Primary Completion
December 31, 2025
Study Completion (Estimated)
December 31, 2026
Last Updated
February 24, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share