EndometriosisCYCLE_ENDONCT06990971
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
An observational study of Endometriosis and Infertility, run by Cycle Therapeutics Ltd.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis, Infertility, Endometrial Cancer
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 31 May 2029
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Menstruating
Who cannot join
- Not menstruating
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Being tested
- No Intervention: Observational Cohort
- Keywords
- Menstrual Fluid, Endometriosis, Tissue modelling
- Medical subject headings
- Endometriosis, Infertility, Endometrial Neoplasms, Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Endometriosis patients | Participants that have had a definitive diagnosis for endometriosis, often through laparoscopic surgery Receives: Other: No Intervention: Observational Cohort | |
| Control | Participants that do not experience any gynaecological symptoms and have not been diagnoses with any gynaecological condition. Receives: Other: No Intervention: Observational Cohort | |
| Symptomatic | Participants that may not have an endometriosis diagnosis, but have another diagnosed condition or display symptoms of endometriosis or dysmenorrhea. Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- - Whether endometriosis is one disease or many sub-diseases, therefore informing how we treat each patient.
- - What endometriosis tissue looks like. This will be used to build our lab models that we will use to test therapies on.
- - What drives progression of the disease. Recurrent measurements will allow us to tease out which processes are involved in disease progression.
- - 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.
Measured: 1-4 years
Secondary outcomes (2)
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.
Measured: 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.
Measured: 1-4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Cycle Therapeutics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990971
- Sponsor's protocol ID
- CYCLETX_OBS_REC_001
- Acronym
- CYCLE_ENDO
- Status last verified
- May 2025
- First submitted
- 18 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06990971
- Acronym / sponsor ID
- CYCLE_ENDO / CYCLETX_OBS_REC_001
- Keywords
- Menstrual Fluid, Endometriosis, Tissue modelling
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cycle Therapeutics LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 4 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Endometriosis patients | – | Other: No Intervention: Observational CohortParticipants that have had a definitive diagnosis for endometriosis, often through laparoscopic surgery |
| Control | – | Other: No Intervention: Observational CohortParticipants that do not experience any gynaecological symptoms and have not been diagnoses with any gynaecological condition. |
| Symptomatic | – | Other: No Intervention: Observational CohortParticipants that may not have an endometriosis diagnosis, but have another diagnosed condition or display symptoms of endometriosis or dysmenorrhea. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Menstruating
Key exclusion criteria (1 listed)
- Not menstruating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortNo 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. | Other | Control, Endometriosis patients, Symptomatic |
Primary outcome
Identifying tissue signatures of endometriosis
Time frame: 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.
2 secondary outcomes
The value of menstrual fluid in health research
Time frame: 1-4 years
Menstrual cell potential
Time frame: 1-4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- The web page for more information and to sign up to donate menstrual fluidLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Infertility, run by Cycle Therapeutics Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Léa MD Wenger, MA, PhD (+447880894277, lwenger@cycletherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identifying tissue signatures of endometriosis (time frame: 1-4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.