Endometriosis, uterine fibroids. Other Endometriosis
Conditions
Interventions
Women of reproductive age (18 years until menopause) who are scheduled to undergo surgery for endometriosis and/or fibroid-associated symptoms. Also, women who have been offered surgery as part of the
Sponsors
University of Oxford, Clinical Trials and Research Governance Team
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Participant is willing and able to give informed consent for participation in the study. 2.Female, aged 18 years or above (before menopause). 3.Women undergoing planned surgery (including hysterectomy) for endometriosis- and/or fibroid associated symptoms such as abdominal pain, abnormal uterine bleeding, or for unrelated gynaecological conditions (e.g. fertility investigation or for laparoscopic tubal sterilisation).
Exclusion criteria
Exclusion criteria: The participant may not enter the study if ANY of the following apply: 1.Women who are pregnant. 2.Women who are unable to read, or to understand written or spoken English. 3.History of cancer/ diagnosis of current cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To identify the underlying mechanisms of endometriosis and uterine fibroids and their associated symptoms to improve the outcome of affected women. We will use questionnaire data, medical records and sample analysis to investigate the genetic and molecular basis of the pathogenesis and symptoms of endometriosis and uterine fibroids. The collected data and samples will be analysed and compared between endometriosis/fibroid cases, and non-affected controls. This work will be ongoing during the duration of the study. Samples will be taken after informed consent at the pre-operation appointment, at surgery and at an optionalfollow-up visit. The questionnaires will be completed at baseline, i.e. before surgery, and in intervals afterwards (6 – 8 weeks, 6 months, 12 months and then yearly for 5 years) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To identify novel biomarkers of endometriosis. Prospective standardised questionnaires (FENOX E or UF) and samples will be collected according to EPHect (Endometriosis Phenome and Biobanking Harmonisation Project) standards. The correlation of data and endometriosis status will allow us to define novel biomarkers of the disease. Time frame as above. 2. To identify clinical subgroups of endometriosis and uterine fibroids. Clinical notes and questionnaires in combination with sample data will be used to define clinical subgroups of patients. Time frame as above. 3. To understand the genetics underlying these conditions and explore the relevant downstream molecular pathways. The molecular and genetic findings will be compared against public databases of disease-relevant molecular pathways, and in vitro experiments will be carried out to test hypothetical connections between the genetics and manifestation of disease. Time frame as above. 4. To investigate the relation between the presence of fibroids and the symptoms, e.g. abnormal uterine bleeding. The blood vessels and the cells they are made of (endothelial cells) will be compared between tissue from women presenting with fibroids and those without. This work will be ongoing during the duration of the study. 5. To identify novel drug targets. The detailed comparison between tissue from women with fibroids and those without will yield differences in terms of proteins expressed; these can then be tested as targets using known or new drugs. Time frame as above. 6. To develop models of disease progression and prediction. As data accumulate and genetic mechanisms become clear, hypotheses will be formed as to the likely progression of disease. These will be tested against the reports from the follow-up questionnaires. This work will be ongoing during the duration of the study, starting once the first questionnaire sets have been completed. | — |
Countries
England, United Kingdom
Contacts
Public ContactChristian Becker
Outcome results
None listed