Urinary miRNA in Endometrial Cancer Study

February 26, 2021 updated by: Royal Cornwall Hospitals Trust

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

164

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Cornwal
      • Truro, Cornwal, United Kingdom, TR13LJ
        • Royal Cornwall Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Endometrial cancer patients

Description

Inclusion Criteria:

  • Confirmed diagnosis of endometrial cancer
  • Age: 18 years or older

Exclusion Criteria:

  • Prior or coexisting other malignancies
  • Autoimmune disorders (other than diabetes mellitus)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Endometrial cancer patients
Diagnostic test: Urinary miRNA
MiRNA detection in urine
Control group
Patients without cancer
Diagnostic test: Urinary miRNA
MiRNA detection in urine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation to final histology
Time Frame: 6 months
To determine how well miRNA correlates with final histology, i.e. can miRNA determine the subtype of endometrial cancer
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Cornwall Hospitals Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2019

Primary Completion (Actual)

March 26, 2020

Study Completion (Actual)

March 26, 2020

Study Registration Dates

First Submitted

December 5, 2018

First Submitted That Met QC Criteria

January 30, 2019

First Posted (Actual)

January 31, 2019

Study Record Updates

Last Update Posted (Actual)

March 1, 2021

Last Update Submitted That Met QC Criteria

February 26, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018.RCHT.97.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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