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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endometriosis patients | Participants that have had a definitive diagnosis for endometriosis, often through laparoscopic surgery |
| |
| Control | Participants that do not experience any gynaecological symptoms and have not been diagnoses with any gynaecological condition. |
| |
| Symptomatic | Participants that may not have an endometriosis diagnosis, but have another diagnosed condition or display symptoms of endometriosis or dysmenorrhea. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention: Observational Cohort | Other | No interventions will be performed specifically for this study. Samples will be collected from menstrual fluid naturally shed or from biopsies and/or operations that are already taking place. |
| Measure | Description | Time Frame |
|---|---|---|
| Identifying tissue signatures of endometriosis | The principal research objective is to identify signatures of endometriosis within the samples collected. These signatures can help us understand:
| 1-4 years |
| Measure | Description | Time Frame |
|---|---|---|
| The value of menstrual fluid in health research | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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All women above the age of 16 will be eligible, although most samples will be collected from those who are menstruating. 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. Because we are trying to broadly understand women's health, we welcome participation of females across all conditions.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Léa MD Wenger, MA, PhD | Contact | +447880894277 | lwenger@cycletherapeutics.com |
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| Label | URL |
|---|---|
| The web page for more information and to sign up to donate menstrual fluid | View source |
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Given the collection of menstrual fluid will occur outside of a primary care centre, personal data will have to be anonymised directly by the company receiving these samples. This will be made clear to participants in the consent form.
Personally identifiable information will only be accessible by a restricted and trained group of people within the organisation or working closely with it.
Analysts from Cycle Therapeutics will only analyse pseudonymised data. Where third parties are employed in the recruitment of participants, they will only be able to access pseudonymised information.
Where appropriate, anonymised data will be shared with collaborators and partners of Cycle Therapeutics, ensuring that there is no way to identify the participants through this information.
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Menstrual Tissue and biopsies will be stored frozen or fixed whole. This includes whole blood, tissue chunks and cells. DNA, RNA and protein may be extracted from the stored samples.
| 1-4 years |
| Menstrual cell potential | We will determine the value of cells isolated from menstrual fluid and biopsies in both disease modelling and therapeutic interventions. | 1-4 years |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D007246 | Infertility |
| D016889 | Endometrial Neoplasms |
| D062788 | Adenomyosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
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