NCT03543215

Brief Summary

Aim: Assess the value of MRI features in predicting prognosis in patients with endometrial cancer This study will examine the MRI features of women with confirmed endometrial cancer to see if textural features can prognosticate patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

June 30, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

July 13, 2017

Completed
11 months until next milestone

First Posted

Study publicly available on registry

June 1, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2021

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2025

Completed
Last Updated

February 12, 2021

Status Verified

February 1, 2021

Enrollment Period

4.4 years

First QC Date

June 30, 2017

Last Update Submit

February 11, 2021

Conditions

Keywords

MRIRadiomicsTexture featuresPrognosticationEndometrial cancer

Outcome Measures

Primary Outcomes (1)

  • To assess the value of MRI features in predicting prognosis in patients with endometrial cancer using progression free survival (PFS) and overall survival (OS) as end points

    Assess features of pelvic MRIs (including (i) tumour image intensity, (II) shape, (III) texture and (IV) multiscale wavelet) and create a mathematical algorithm to predict prognostic outcome (5 year survival).

    8 years (3 year data collection and 5 year follow up).

Secondary Outcomes (1)

  • Assess the correlation between imaging features and histopathological features.

    3 years

Interventions

All patients with confirmed endometrial cancer will have received Ultrasound and MRI as part of routine standard of care. Textural features from this will be analysed to see if can predict prognosis.

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsStudy is on endometrial cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients reviewed at the Specialist Gynaecology Oncology MDT at ICHNT with a diagnosis of endometrial cancer

You may qualify if:

  • All women presenting with a confirmed diagnosis of endometrial cancer
  • Reviewed at the Specialist Gynaecology Oncology MDT
  • Have MR Imaging and Hysterectomy specimens available for review.

You may not qualify if:

  • Anyone lacking capacity.
  • \<18years old.
  • Pregnant.
  • No MR Imaging available for review -- No pathology specimen available for review

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Charlotte and Hammersmith Hospital

London, W12 0HS, United Kingdom

RECRUITING

Related Publications (1)

  • Li X, Marcus D, Russell J, Aboagye EO, Ellis LB, Sheeka A, Park WE, Bharwani N, Ghaem-Maghami S, Rockall AG. Weibull parametric model for survival analysis in women with endometrial cancer using clinical and T2-weighted MRI radiomic features. BMC Med Res Methodol. 2024 May 9;24(1):107. doi: 10.1186/s12874-024-02234-1.

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Magnetic Resonance SpectroscopyHigh-Energy Shock Waves

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesUltrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Central Study Contacts

Diana Marcus, MB BS

CONTACT

Study Design

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

Study Record Dates

First Submitted

June 30, 2017

First Posted

June 1, 2018

Study Start

July 13, 2017

Primary Completion

December 10, 2021

Study Completion

December 10, 2025

Last Updated

February 12, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations