Harnessing the Disease Signatures From Endometrium and Menstrual Blood to Identify Avenues for the Treatment of Chronic Conditions Such as Endometriosis and Related Pathologies: This is an Observational Study Aimed at Shedding Light on Women's Health
- Conditions
- EndometriosisInfertilityEndometrial CancerAdenomyosis, Endometriosis
- Registration Number
- NCT06990971
- Lead Sponsor
- Cycle Therapeutics Ltd
- Brief Summary
Many women's health conditions have limited treatments available and poor outcomes, in part due to the lack of understanding of disease processes and lack of data available. This study aims to build knowledge in women's health by leveraging the information we can gather from menstrual fluid and the uterus. By looking at samples from menstrual fluid and biopsies and associating it with health outcomes of the people donating these samples, we will be able to find new signatures of disease. This can help us find early diagnostic markers, better classify diseases and give us the tools that allow us to build the right models in the lab to find new treatments. By collecting this data, we will be able to identify patterns within given diseases that can help us cure them and derive the cells necessary to model the disease. The study is funded and undertaken by Cycle Therapeutics, a company with the mission of curing endometriosis. All women above the age of 16 will be eligible, although most samples will be collected from those who are menstruating or already undergoing biopsies/surgical tissue removal. Women with endometriosis or suspicion of the disease are encouraged to take part, but participation of people without any symptoms or conditions is important to understand what the base healthy state looks like. Most of the sample processing will be done within Cycle and collection will occur at clinics or remotely, and can be as simple as pouring menstrual fluid from a cup into a tube to ship to Cycle. The study will last four years, during which we hope to build a strong understanding of conditions affecting women. We will be able to provide health insight to donors after each donation, but the greatest value in this study will lie in the new treatments we can discover thanks to our novel understanding.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 200
- Menstruating
- Not menstruating
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Identifying tissue signatures of endometriosis 1-4 years The principal research objective is to identify signatures of endometriosis within the samples collected. These signatures can help us understand:
1. - Whether endometriosis is one disease or many sub-diseases, therefore informing how we treat each patient.
2. - What endometriosis tissue looks like. This will be used to build our lab models that we will use to test therapies on.
3. - What drives progression of the disease. Recurrent measurements will allow us to tease out which processes are involved in disease progression.
4. - How endometriosis cells compare to control cells in a dish. This will be critical to establishing the right read outs for our search of novel drugs that can reverse the disease.
- Secondary Outcome Measures
Name Time Method The value of menstrual fluid in health research 1-4 years When collecting the clinical and biological data from donors, we may be able to identify early diagnostic markers of certain particular conditions, or predict the prognosis of others. We may also find a very robust signature of another disease related or unrelated to endometriosis. Our aim is to more broadly assess the descriptive value of menstrual fluid and tissue biopsies.
Menstrual cell potential 1-4 years We will determine the value of cells isolated from menstrual fluid and biopsies in both disease modelling and therapeutic interventions.