Endometrial CancerNCT03824613
Urinary miRNA in Endometrial Cancer Study
An observational study of Endometrial Cancer, run by Royal Cornwall Hospitals Trust at 1 site in United Kingdom.
Trial summary
This study is a prospective feasibility study with the addition of a retrospective cohort study on the the expression of microRNA in urine in endometrial cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Urinary miRNA
- How many people
- 164 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Mar 2019to 26 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Endometrial cancer patients
Who may be able to join
- Confirmed diagnosis of endometrial cancer
- Age: 18 years or older
Who cannot join
- Prior or coexisting other malignancies
- Autoimmune disorders (other than diabetes mellitus)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Urinary microRNA Expression in Endometrial Cancer Patients - a Feasibility Study
This study is a prospective feasibility study with the addition of a retrospective cohort study on the the expression of microRNA in urine in endometrial cancer patients.
- Conditions
- Endometrial Cancer
- Being tested
- Urinary miRNA
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary miRNADiagnostic test
MiRNA detection in urine
| Study group | Role | What they receive |
|---|---|---|
| Endometrial cancer patients | Not described Receives: Diagnostic Test: Urinary miRNA | |
| Control group | Patients without cancer Receives: Diagnostic Test: Urinary miRNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of predictive value of miRNA test in detecting endometrial cancer
To determine if miRNA can distinguish endometrial cancer patients from healthy patients
Measured: 6 months
Secondary outcomes (1)
Correlation to final histology
To determine how well miRNA correlates with final histology, i.e. can miRNA determine the subtype of endometrial cancer
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start8 Mar 2019
- Primary completion26 Mar 2020
- Study completion26 Mar 2020
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.
- 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
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Cornwall Hospitals Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824613
- Sponsor's protocol ID
- 2018.RCHT.97.
- Status last verified
- Feb 2021
- First submitted
- 5 Dec 2018
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary microRNA Expression in Endometrial Cancer Patients - a Feasibility Study
- ClinicalTrials.gov ID
- NCT03824613
- Acronym / sponsor ID
- 2018.RCHT.97.
- Conditions
- Endometrial Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Royal Cornwall Hospitals TrustUniversity, hospital or other
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 26 Mar 2020 (actual)
- Study completion
- 26 Mar 2020 (actual)
- First posted
- 31 Jan 2019 (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.
This study is a prospective feasibility study with the addition of a retrospective cohort study on the the expression of microRNA in urine in endometrial cancer patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometrial cancer patients | – | Diagnostic Test: Urinary miRNA |
| Control group | – | Diagnostic Test: Urinary miRNAPatients without cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Endometrial cancer patients
Key inclusion criteria (2 listed)
- Confirmed diagnosis of endometrial cancer
- Age: 18 years or older
Key exclusion criteria (2 listed)
- Prior or coexisting other malignancies
- Autoimmune disorders (other than diabetes mellitus)
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 |
|---|---|---|
| Urinary miRNAMiRNA detection in urine | Diagnostic test | Control group, Endometrial cancer patients |
Primary outcome
Accuracy of predictive value of miRNA test in detecting endometrial cancer
Time frame: 6 months
To determine if miRNA can distinguish endometrial cancer patients from healthy patients
1 secondary outcome
Correlation to final histology
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Individual participant dataSharing planned: No
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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 Royal Cornwall Hospitals Trust 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 2 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: finished, as of the sponsor's last update on 1 Mar 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Accuracy of predictive value of miRNA test in detecting endometrial cancer (time frame: 6 months). 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 1 Mar 2021.