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
CYCLE_ENDO
1 other identifier
observational
200
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2025
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2025
CompletedFirst Posted
Study publicly available on registry
May 25, 2025
CompletedStudy Start
First participant enrolled
June 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2029
May 25, 2025
May 1, 2025
4 years
May 18, 2025
May 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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. \- 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.
1-4 years
Secondary Outcomes (2)
The value of menstrual fluid in health research
1-4 years
Menstrual cell potential
1-4 years
Study Arms (3)
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- Menstruating
You may not qualify if:
- Not menstruating
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
Biospecimen
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.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- OTHER
- Target Duration
- 4 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2025
First Posted
May 25, 2025
Study Start
June 1, 2025
Primary Completion (Estimated)
May 31, 2029
Study Completion (Estimated)
May 31, 2029
Last Updated
May 25, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share
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.