Endometrial CancerBioMECNCT06800677
Methylated Biomarkers Predictive of Endometrial Cancer Risk
An observational study of Endometrial Cancer, run by University of Manchester at 1 site in United Kingdom.
Trial summary
The goal of this observational study is to identify endometrial cancer risk predictive biomarkers and to optimise the methodology for their detection and quantification in non-invasive samples. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Hysterectomy
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Jul 2024to Dec 2026
- 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 45 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women undergoing an elective hysterectomy at St Mary's Hospital, Manchester, UK for either endometrial cancer or a benign indication
Who may be able to join
- Women aged 45-70 years
- Attending St Mary's Hospital, Manchester for an elective hysterectomy by any route for either the treatment of endometrial cancer or a benign gynaecological condition
- Able to consent to participation in the study
Who cannot join
- Presence of malignancy asides from endometrial cancer
- Undergoing elective hysterectomy for suspected ovarian cancer
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University NHS Foundation Trust
Manchester, M13 9WL
About this study
The goal of this observational study is to identify endometrial cancer risk predictive biomarkers and to optimise the methodology for their detection and quantification in non-invasive samples.
- Conditions
- Endometrial Cancer
- Being tested
- Hysterectomy
- Keywords
- risk, prevention, prediction
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HysterectomyProcedure or surgery
Elective hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| Cases | Women diagnosed with endometrial cancer of any grade, stage and histological type Receives: Procedure: Hysterectomy | |
| Controls | Women undergoing a hysterectomy for benign indications Receives: Procedure: Hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, specificity, negative and positive predictive value of single gene methylation classifiers in predicting the presence of endometrial cancer in minimally- and invasive samples
Measured: 1 day
Secondary outcomes (1)
Sensitivity, specificity, positive and negative predictive value of a multi-gene methylation classifier for predicting the presence of endometrial cancer
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start31 Jul 2024
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary University of London
- Responsible party
- Principal investigator, Sarah Kitson, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800677
- Sponsor's protocol ID
- 334940
- Acronym
- BioMEC
- Status last verified
- Jul 2024
- First submitted
- 31 Jul 2024
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Researchers to write to CI requesting IPD. Fully anonymised data may be shared with other researchers upon receipt of approval from relevant ethics committee
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylated Biomarkers Predictive of Endometrial Cancer Risk
- ClinicalTrials.gov ID
- NCT06800677
- Acronym / sponsor ID
- BioMEC / 334940
- Conditions
- Endometrial Cancer
- Keywords
- risk, prevention, prediction
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- Queen Mary University of London
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Jan 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.
The goal of this observational study is to identify endometrial cancer risk predictive biomarkers and to optimise the methodology for their detection and quantification in non-invasive samples.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Procedure: HysterectomyWomen diagnosed with endometrial cancer of any grade, stage and histological type |
| Controls | – | Procedure: HysterectomyWomen undergoing a hysterectomy for benign indications |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women undergoing an elective hysterectomy at St Mary's Hospital, Manchester, UK for either endometrial cancer or a benign indication
Key inclusion criteria (3 listed)
- Women aged 45-70 years
- Attending St Mary's Hospital, Manchester for an elective hysterectomy by any route for either the treatment of endometrial cancer or a benign gynaecological condition
- Able to consent to participation in the study
Key exclusion criteria (2 listed)
- Presence of malignancy asides from endometrial cancer
- Undergoing elective hysterectomy for suspected ovarian cancer
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 |
|---|---|---|
| HysterectomyElective hysterectomy | Procedure or surgery | Cases, Controls |
Primary outcome
Sensitivity, specificity, negative and positive predictive value of single gene methylation classifiers in predicting the presence of endometrial cancer in minimally- and invasive samples
Time frame: 1 day
1 secondary outcome
Sensitivity, specificity, positive and negative predictive value of a multi-gene methylation classifier for predicting the presence of endometrial cancer
Time frame: 1 day
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 30 Jan 2025.
- Individual participant dataSharing planned: Undecided. Researchers to write to CI requesting IPD. Fully anonymised data may be shared with other researchers upon receipt of approval from relevant ethics committee
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer, run by University of Manchester at 1 site in United Kingdom.
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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity, specificity, negative and positive predictive value of single gene methylation classifiers in predicting the presence of endometrial cancer in minimally- and invasive samples (time frame: 1 day). 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 30 Jan 2025.