NCT05339451 Blood and Tissue Markers for Improving Diagnosis and Prognosis of Endometriosis. (ENDOBIO)
| NCT ID | NCT05339451 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Region Stockholm |
| Condition | Endometriosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 345 participants |
| Start Date | 2023-05-04 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 345 participants in total. It began in 2023-05-04 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Kenny Rodriguez-Wallberg, Professor
PRINCIPAL INVESTIGATOR
Karolinska Institutet
Frequently Asked Questions
Who can join the NCT05339451 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Endometriosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05339451 currently recruiting?
Yes, NCT05339451 is actively recruiting participants. Contact the research team at anastasia.drakou@regionstockholm.se for enrollment information.
Where is the NCT05339451 trial being conducted?
This trial is being conducted at Stockholm, Sweden, Stockholm, Sweden, Uppsala, Sweden.
Who is sponsoring the NCT05339451 clinical trial?
NCT05339451 is sponsored by Region Stockholm. The principal investigator is Kenny Rodriguez-Wallberg, Professor at Karolinska Institutet. The trial plans to enroll 345 participants.