Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Enrolling By Invitation NCT05623332

Assessment of Integrin Expression in Endometriosis

Conditions: Endometriosis

Sex: Female
Ages: 18 Years – 80 Years
Enrollment: 25
Sponsor: University of Oxford

Location: United Kingdom

Summary

Endometriosis is a common gynaecological disease affecting 10% of the female population due to the presence of uterus-like tissue outside of the uterus, often in the pelvis. The disease causes severe lower abdominal pain mostly during the monthly period, during or after sexual intercourse, and when emptying the bowel and bladder. Currently, imaging methods such as ultrasound are ineffective at diagnosing the most common type of endometriosis, pelvic endometriosis. Therefore, we are heavily reliant on invasive surgery to make the diagnosis.This study aims to investigate the presence of binding proteins (integrins) in endometriotic tissue which will expand our understanding of endometriosis and could be used as a target to develop a non-invasive imaging test in the future.Women with symptoms consistent with endometriosis, who are due to undergo surgery to diagnose endometriosis at the EndoCare Unit in Oxford, will be eligible to participate. To attempt to visualise the integrins, participants will be asked to attend 2-7 days before their surgery to undergo an imaging scan with a molecular marker that has been found to highlight integrins in other conditions. The possibility of machine learning enhancement of integrin expression will be tested. The findings on the scan will be compared to the findings at surgery. Samples during surgery of endometriosis tissues, the endometrium, and salty water that has been flushed through the uterus, will be analysed in the lab to look for differences in the amount of integrin present in women with and without endometriosis and whether factors such as the phase of the menstrual cycle or hormonal treatment effect the amount seen.

Eligibility Criteria

Inclusion Criteria:Participant is willing and able to give informed consent for participation in the study.Female aged 18 years or above.Symptoms consistent with endometriosis and therefore due to undergo a laparoscopy for diagnostic (+/- therapeutic) purposes.Willing and able to comply with scheduled visits.In the Investigator's opinion, is able and willing to comply with all study requirements.Women enrolling for the tissue sample comparison group: Women undergoing planned surgery (including hysterectomy) for gynaecological disease except endometriosis e.g., fibroid-associated symptoms such as abdominal pain, abnormal uterine bleeding, fertility investigation or for laparoscopic tubal sterilisation.Exclusion Criteria:Female participant who is pregnant, lactating or planning pregnancy during the study.Known significant renal or hepatic impairment (E.g., eGFR <50ml/min/1.73m2 on recent blood tests).Any significant disease or disorder such as gynaecological cancers, in the opinion of the Investigator, may either put the participants at risk because of participation in the study or may influence the result of the study.High dose intravenous or intramuscular steroid in the past 12 weeks.Participants with a known allergy to technetium.Participants who have recently participated in another research study, in the opinion of the investigator will affect the results of the project.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05623332). StuddyBuddy aggregates publicly available trial information.