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)

Cycle Therapeutics Ltd

Status: Not yet enrolling

Conditions: Endometrial Cancer; Adenomyosis, Endometriosis; Infertility; Endometriosis

Treatments: Other: No Intervention: Observational Cohort

Study type: Observational

Funder types: Industry

Identifiers

NCT06990971

CYCLETX_OBS_REC_001

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Menstruating

Exclusion criteria

• Not menstruating

Trial design

200 participants in 3 patient groups

Endometriosis patients

Description:

Participants that have had a definitive diagnosis for endometriosis, often through laparoscopic surgery

Treatment:

Other: No Intervention: Observational Cohort

Control

Description:

Participants that do not experience any gynaecological symptoms and have not been diagnoses with any gynaecological condition.

Treatment:

Other: No Intervention: Observational Cohort

Symptomatic

Description:

Participants that may not have an endometriosis diagnosis, but have another diagnosed condition or display symptoms of endometriosis or dysmenorrhea.

Treatment:

Other: No Intervention: Observational Cohort