Clinical trial NCT06990971: 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
Official title: Harnessing the Disease Signatures From Endometrium and Menstrual Blood to Identify Avenues for the Treatment of Chronic Conditions Such as Endometriosis and Related Pathologies
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Endometriosis
Infertility
Endometrial Cancer
Adenomyosis, Endometriosis
Keywords: Menstrual Fluid
Endometriosis
Tissue modelling
Lead sponsor: Cycle Therapeutics Ltd
Sponsor class: INDUSTRY
First posted: 2025-05-25
Enrollment: 200
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: Inclusion Criteria:

* Menstruating

Exclusion Criteria:

* Not menstruating

Primary outcomes:
measure: Identifying tissue signatures of endometriosis
timeFrame: 1-4 years
Secondary outcomes:
measure: The value of menstrual fluid in health research
timeFrame: 1-4 years
measure: Menstrual cell potential
timeFrame: 1-4 years
Other outcomes:
Locations:
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