ENDO1000 - A UK-wide Endometriosis Research Project
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- To generate a unique biomedical endometriosis resource with detailed clinical and lifestyle phenotyping.
研究概览
简要总结
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.
详细描述
BACKGROUND Endometriosis is characterised by the presence of endometrial-like tissue ('lesions') outside the uterus, commonly on the lining of the pelvic cavity. It is a chronic, inflammatory gynaecological condition that affects approximately 6-10% of women and those assigned female at birth. It is associated with debilitating pelvic pain, gastrointestinal and urinary symptoms, fatigue and infertility. Endometriosis can profoundly affect quality of life, limiting daily activities, social engagement, physical and sexual health, relationships, career and educational pursuits, mental well-being, and overall health. It is associated with a 45% reduction in work productivity with an annual cost for caring for women with endometriosis estimated at > £8.2 billion per year in the UK.
People with endometriosis experience an average of 8 years of delay in the UK from the onset of their symptoms before receiving a diagnosis. There are no validated non-invasive tests for endometriosis and the current gold standard for diagnosis is via a diagnostic laparoscopy. Currently, the waiting time for this procedure in the UK is variable across NHS Trusts and can be up to two years.
Treatment options typically include:
- Painkillers e.g. paracetamol, NSAIDs.
- Surgery to remove endometriosis lesions, although this is ineffective in an estimated 30 % of women and, even when its effective, symptoms return in up to 50% of women within 5 years of surgery.
- Hormone therapies, which are not curative, can have significant side effects and are contraceptive.
Some individuals explore lifestyle changes, such as dietary adjustments or exercise, but research on the effectiveness of these approaches remains limited.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Known severe coagulation disorder
- •Known active Hepatitis B/C and/or HIV (due to Royal Mail restrictions on biospecimen postage)
结局指标
主要结局
To generate a unique biomedical endometriosis resource with detailed clinical and lifestyle phenotyping.
时间窗: 5 years
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.
次要结局
- To use the biomedical endometriosis resource to address fundamental questions in our understanding of endometriosis.(5 years)