CT Assessment of BMI in Endometrial Cancer Patients | NCT03962140

Studies
CT Assessment of BMI in Endometrial Cancer Patients

NCT03962140

Sponsor

Royal Cornwall Hospitals Trust

Status

Completed

Last Update Posted

Sep 16, 2021Actual

Enrollment

302Actual

Phase

Not provided

Conditions

Endometrial Cancer

Interventions

Not provided

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

Sep 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

Aug 1, 2019Actual

Primary Completion Date

Mar 1, 2021Actual

Completion Date

Mar 31, 2021Actual

First Submitted Date

Apr 17, 2019

First Submission Date that Met QC Criteria

May 22, 2019

First Posted Date

May 23, 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

Sep 15, 2021

Last Update Posted Date

Sep 16, 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 retrospective study to investigate the association between body fat distribution and sarcopenia on CT-scan and oncological outcomes 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

No data available

No data is available for this block.

Enrollment

302Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Investigation of Patients with High BMI and Survival Rates	To investigate the association between body fat distribution and sarcopenia on CT-scan and survival in endometrial cancer patients	10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed diagnosis of endometrial cancer
Age: 18 years or older
Abdominal CT-scan as part of pre-operative or post-operative staging work-up (<1 month after surgery)

Exclusion Criteria:

Women with concurrent cancer
Women with unknown body mass index

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

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	Cornwall	TR1 3LJ	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D016889	Endometrial Neoplasms
D009765	Obesity
D055948	Sarcopenia

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