NCT07114081Completed
EndometrioSis PRediction and Assessment of InflammaTion
Exploring Pre-operative Prediction of Pelvic Endometriosis, the Local Inflammatory Environment and Response to Surgical Treatment
Source: ClinicalTrials.gov · Last updated 11 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this observational study is to develop a non-invasive predictive algorithm for a diagnosis of endometriosis in a group of symptomatic women attending for their first laparoscopic surgical procedure for symptoms that are suspicious for pelvic endometriosis and to understand the role of peripheral markers of inflammation in enhancing this diagnosis. The main questions it aims to answer are: Can a non-invasive quantitative algorithm ('Endometriosis Diagnostic Index') accurately predict the presence or absence of pelvic endometriosis? Is the peripheral inflammatory environment (for example, presence of inflammatory cytokines and chemokine) different between people with and without endometriosis?
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 264 (actual)
- First submitted
- 3 Aug 2025
- Start date
- 1 Jul 2022
- Primary completion date
- 1 Feb 2024
- Lead sponsor
- Imperial College London
- Diseases
- Endometriosis
- NCT number
- NCT07114081
What you commit to
- Study type: Observational
- Participants enrolled: 264
- From 1 Jul 2022 to the primary completion date, 1 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous surgically confirmed endometriosis;
- where gynaecology is not the primary team undertaking surgery;
Other illness
- suspicion of malignancy;
- significant medical co-morbidities including HIV and/or hepatitis B or C infection;
Other
- postmenopausal status;
- laparoscopy for acute indication (ectopic; tubo-ovarian abscess; adnexal torsion);
- the sole indication of tubal sterilisation;
- the sole indication of myomectomy;
- pregnant or breastfeeding;
- unable to have transvaginal ultrasound (TVUSS);
- declines to take part in the study;
- patient unable to understand verbal or written information in English;
- lack of capacity to consent at the point of recruitment;
- known safeguarding issues.
Who the study is looking for
- Consecutive female patients age 18-50 undergoing laparoscopy with the suspicion of endometriosis (as indicated by any recording in secondary care medical notes of endometriosis being a possible finding at laparoscopy; all those undergoing laparoscopy for sub-fertility (no conception after ≥6 months of trying, excluding confirmed male factor); or pelvic pain symptoms (dysmenorrhea; non-cyclical pelvic pain; dyspareunia; dyschezia) who is not otherwise excluded.
Age in the registry: 18 years to 50 years · Sex: Female
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chelsea and Westminster Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.