ENDO1000 - A UK-wide Endometriosis Research Project

ConditionEndometriosis

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age16+

SponsorUniversity of Edinburgh

About this trial

Approximately 1.5 million people in the UK, and 200 million globally live with endometriosis, and it is estimated to affect 1 in 10 women of reproductive age. Endometriosis is a chronic pain condition where the lining of the uterus (endometrium) grows in areas outside the uterus. This can cause patients a range of symptoms including severe pain, fatigue, irregular periods, infertility and gastrointestinal symptoms.

There is a clear unmet need for early diagnosis and more effective pain management for people who suffer from endometriosis. Endometriosis is a heterogeneous disease in terms of symptoms, trajectory, and indicated therapeutic course, which highlights the need to develop personalised/targeted approaches for effective longitudinal management which are acceptable and accessible to patients and their health care team.

The goal of this study is to accelerate discovery and advance data-driven research into endometriosis diagnosis and treatment by collecting large, multimodal, longitudinal data.

To achieve this goal, the investigators plan to deliver a longitudinal cohort study. Approximately 3000 UK individuals with endometriosis will be invited over a 24-month period to self-report symptoms that include, pain, menstrual cycle, painkiller use, sleep, exercise, diet and bowel habits via a bespoke ENDO1000 mobile app. A cohort of 1000 women will be asked to complete more in-depth questionnaires asking about endometriosis history, quality of life and treatments. This cohort of women will be asked to take self-collected biological samples (blood, urine, saliva, vaginal swab and faeces). The investigators will look at, for example, inflammatory markers, examine the microbiome and may look at DNA, with permission to see if there are any markers that can help with diagnosis or treatment of endometriosis. At the same time participants will be asked to wear a smartwatch which will monitor, for example, temperature, ambient light, sleep patterns and movement. All this will help the investigators to build a picture over time of the participant's endometriosis symptoms, treatments and what may cause symptoms to flare which in turn could lead to more patient led treatments.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 16 or over

Participants who confirm that they have received a clinical diagnosis of endometriosis (based on MRI, ultrasound or laparoscopy) within the last 10 years

Living within the UK

Willing and able to consent to installing and using the mobile ENDO1000 app on their smartphone or use our web-based equivalent.

Disqualifiers

Pregnant

Known severe coagulation disorder

Known active Hepatitis B/C and/or HIV (due to Royal Mail restrictions on biospecimen postage)

Trial population

Anyone living within the UK with a self-reported diagnosis of endometriosis

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Sample and data collection
Biological/Vaccine
We will collect data via a bespoke mobile application which will include; pain, fatigue, sleep patterns, diet, bowel habits, exercise, painkiller use, hormone use from participants with endometriosis. In a subset of the participants, we will collect biological samples which will be self collected at home, that will include, blood, saliva, urine and faeces. At time of sample collected, we will also ask a selection of validated questionnaires to be completed.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

To generate a unique biomedical endometriosis resource with detailed clinical and lifestyle phenotyping.

This study aims to characterise overall endometriosis symptom severity. This is a multifaceted objective to cover the breadth of symptoms of endometriosis and there is not a single scale that captures this that could be assigned as "primary outcome measure". We aim to define a new gold standard, on the basis of the largest longitudinal multimodal endometriosis study ever conducted. We envisage the resulting clinical score will be derived by combining different symptoms as experienced by patients and combining different data modalities. Specifically, we will elicit responses where participants self-quantify: pain (EHP-30), fatigue (BFI), sleep problems (PSQI and PROMIS), bowel habits (NHS questionnaire), diet (FFQ), epidemiological and genetic data (WERF EPHect Patient Questionnaire). Additional inputs will be provided by biological samples and data from a wrist-worn wearable sensor, from which we have validated algorithms to characterise physical activity, sleep and diurnal rhythm.

Time frame

5 years

Secondary outcomes

To use the biomedical endometriosis resource to address fundamental questions in our understanding of endometriosis.

(i) To investigate the potential for patient stratification/prediction of treatment response from clinical/biological data profiles. (ii) To investigate the relationship between symptoms of pelvic pain and the gut-brain axis (including microbiome) using multi-omics data. (iii) To demonstrate longitudinal endometriosis symptom trajectories using app-based patient reported outcome measures (PROMs) and wearable technology.

Time frame

5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Edinburgh

Lead sponsor

Clinical Hospital Centre Zagreb

Collaborator

Endometriosis UK