Urinary miRNA in Endometrial Cancer Study

Completed

• Conditions: Endometrial Cancer
• Interventions: Diagnostic Test: Urinary miRNA

• Registration Number: NCT03824613
• Lead Sponsor: Royal Cornwall Hospitals Trust

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-05
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-01-31
• Study Start: 2019-03-08
• Primary Completion: 2020-03-26
• Study Completion: 2020-03-26
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-26
• Last Update Posted: 2021-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 164

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endometrial cancer patients	Urinary miRNA	-
Control group	Urinary miRNA	Patients without cancer

Primary Outcome Measures

Name	Time	Method
Accuracy of predictive value of miRNA test in detecting endometrial cancer	6 months	To determine if miRNA can distinguish endometrial cancer patients from healthy patients

Secondary Outcome Measures

Name	Time	Method
Correlation to final histology	6 months	To determine how well miRNA correlates with final histology, i.e. can miRNA determine the subtype of endometrial cancer

Trial Locations

Locations (1)

Royal Cornwall Hospital; 🇬🇧 Truro, Cornwal, United Kingdom