A study to identify possible biomarkers in women with Endometriosis at Oxford University.
Many women have a condition called endometriosis that causes painful periods and sometimes infertility. At the moment, the only way this condition can be diagnosed is for the woman to have an operation called a laparoscopy, so that the doctor can look inside her abdomen (tummy). The ultimate goal of this study is to develop a simple blood or urine test that could tell us if a woman has endometriosis. The advantage of developing such a test is that women would no longer need to have a laparoscopy to help diagnose endometriosis.
Endometriosis is diagnosed in about 8-10% of women reproductive age, but may affect up to 50% of women in certain subgroups, such as women undergoing fertility investigations or hysterectomy. There is often considerable delay between the onset of symptoms and definitive diagnosis, which is due to the cost and invasive nature of the diagnostic procedure (laparoscopy) and the non-specific nature of symptoms. Clearly a non-invasive test is safer and likely to be more acceptable to patients as a diagnostic biomarker. Furthermore, such a biomarker may also be of use in evaluating new drug therapies for endometriosis. In this study we aim to identify potential biomarkers in blood, urine and tissue and try to correlate its presence/absence with the stage and clinical signs of the disease. Current treatment is associated with approximately 50% recurrence rates. A suitable biomarker could possibly identify disease recurrence before it becomes clinically symptomatic avoiding unnecessary surgery and/or suffering by the patient.
Biomarker and drug target discovery, and the translation of genetic results into clinically useful outcomes, requires the collection of biological samples along with detailed symptomatic, clinical, and personal information from women with and without endometriosis. For this purpose we started ENDOX, a prospective study in which we systematically collect blood, urine, saliva, and tissue from women undergoing a laparoscopy for pelvic pain, infertility or sterilisation, and asking each participant to complete detailed questionnaires prior to and following surgery. The samples and data collected as part of ENDOX are used for a number of studies aimed at finding – and translating our genetic findings into – biomarkers, improve our understanding of underlying disease mechanisms and develop novel treatments for endometriosis and its associated symptoms.
Endometriosis is a common disease in women, which, in the vast majority of cases, can only be diagnosed by abdominal surgery. The symptoms such as abdominal pain and infertility are fairly unspecific resulting in delays in diagnosis and treatment by an average of 8-10 years. The principal research objective is to identify biomarkers that can help make the diagnosis of endometriosis and that can also potentially be used to monitor therapeutic efficacy.
- To relate the presence or absence of identified biomarkers to disease severity assessed either by visual inspection of the pelvis (scored using the American Fertility Score), or to patient reported pain scores or quality of life scale (Endometriosis Health Profile-30 at baseline). Post-Operative Assessment Questionnaires at different time points (e.g. and approximately 6-8 weeks, 6 months, 12 months and 24 months after surgical/medical intervention).
- To understand if any identified blood, saliva or urine markers are present in endometriotic lesions or eutopic endometrium, or if they represent a host response to the presence of endometriosis.
- To collect anonymised blood and urine samples for pharmacogenomics.
- To collect endometrial tissue for implantation in mice to use as an established model for endometriosis to test novel therapeutic approaches and understand the pathophysiology of the disease.
- To investigate the effect of current therapies on the expression of biomarkers.
WITHDRAWAL OF PARTICIPANTS FROM STUDY
Each participant has the right to withdraw from the study at any time. In addition, the Investigator may discontinue a participant from the study at any time if the Investigator considers it necessary for any reason including:
- Ineligibility (either arising during the study or retrospectively, having been missed at screening)
- Withdrawal of Consent
- Loss to follow up
- Loss of mental capacity
If you would like to be withdrawn from the study, please contact us at: firstname.lastname@example.org
Funding for this study has been obtained from the Nuffield Department of Obstetrics and Gynaecology under the Oxford/Bayer-Alliance for Women’s Health.