ENDO1000 - A UK-wide Endometriosis Research Project

Summary

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.

Conditions

• Endometriosis

Interventions

BIOLOGICAL

Sample and data collection

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.

Sponsors & Collaborators

• Clinical Hospital Centre Zagreb

  collaborator OTHER

• Endometriosis UK

  collaborator UNKNOWN

• University of Edinburgh

  lead OTHER

Principal Investigators

• Andrew W Horne, PhD, MB ChB · University of Edinburgh

Eligibility

Min Age

16 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-05

Primary Completion

2030-12-31

Completion

2030-12-31

Countries

• United Kingdom

Study Locations