NCT03824613

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

March 8, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2020

Completed
Last Updated

March 1, 2021

Status Verified

February 1, 2021

Enrollment Period

1.1 years

First QC Date

December 5, 2018

Last Update Submit

February 26, 2021

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

  • Accuracy of predictive value of miRNA test in detecting endometrial cancer

    To determine if miRNA can distinguish endometrial cancer patients from healthy patients

    6 months

Secondary Outcomes (1)

  • Correlation to final histology

    6 months

Study Arms (2)

Endometrial cancer patients

Diagnostic Test: Urinary miRNA

Control group

Patients without cancer

Diagnostic Test: Urinary miRNA

Interventions

Urinary miRNADIAGNOSTIC_TEST

MiRNA detection in urine

Control groupEndometrial cancer patients

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Endometrial cancer patients

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Cornwall Hospital

Truro, Cornwal, TR13LJ, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

miRNA in urine

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2018

First Posted

January 31, 2019

Study Start

March 8, 2019

Primary Completion

March 26, 2020

Study Completion

March 26, 2020

Last Updated

March 1, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)