Urinary miRNA in Endometrial Cancer Study | NCT03824613

Studies
Urinary miRNA in Endometrial Cancer Study

NCT03824613

Sponsor

Royal Cornwall Hospitals Trust

Status

Completed

Last Update Posted

Mar 1, 2021Actual

Enrollment

164Actual

Phase

Not provided

Conditions

Endometrial Cancer

Interventions

Urinary miRNA

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 8, 2019Actual

Primary Completion Date

Mar 26, 2020Actual

Completion Date

Mar 26, 2020Actual

First Submitted Date

Dec 5, 2018

First Submission Date that Met QC Criteria

Jan 30, 2019

First Posted Date

Jan 31, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2021

Last Update Posted Date

Mar 1, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

164Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Endometrial cancer patients			Diagnostic Test: Urinary miRNA
Control group		Patients without cancer	Diagnostic Test: Urinary miRNA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Urinary miRNA	Diagnostic Test	MiRNA detection in urine	Control group Endometrial cancer patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Endometrial cancer patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Cornwall Hospital		Truro	Cornwal	TR13LJ	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016889	Endometrial Neoplasms

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided