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出境医 / 临床实验 / CT Assessment of BMI in Endometrial Cancer Patients

CT Assessment of BMI in Endometrial Cancer Patients

Study Description
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

Condition or disease
Endometrial Cancer

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Computed Tomography Assessment of Body Fat Distribution in Endometrial Cancer Patients
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2021
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. The Investigation of Patients with High BMI and Survival Rates [ Time Frame: 10 years ]
    To investigate the association between body fat distribution and sarcopenia on CT-scan and survival in endometrial cancer patients


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Endometrial cancer patients
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
Contacts and Locations

Contacts
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Contact: Hannah Donkers 01872252037 hannah.donkers@nhs.net

Locations
Layout table for location information
United Kingdom
Royal Cornwall Hospital Recruiting
Truro, Cornwall, United Kingdom, TR1 3LJ
Contact: Hannah Donkers         
Sponsors and Collaborators
Royal Cornwall Hospitals Trust
Tracking Information
First Submitted Date April 17, 2019
First Posted Date May 23, 2019
Last Update Posted Date June 22, 2020
Actual Study Start Date August 1, 2019
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 10, 2019) 		The Investigation of Patients with High BMI and Survival Rates [ Time Frame: 10 years ]
To investigate the association between body fat distribution and sarcopenia on CT-scan and survival in endometrial cancer patients
Original Primary Outcome Measures
 (submitted: May 22, 2019)
  • Survival [ Time Frame: 10 years ]
    To investigate the association between body fat distribution and sarcopenia on CT-scan and survival in endometrial cancer patients
  • Recurrence rates [ Time Frame: 10 years ]
    To investigate the association between body fat distribution and sarcopenia on CT-scan and recurrence rates in endometrial cancer patients
  • Adjuvant treatment [ Time Frame: 10 years ]
    To investigate the association between body fat distribution and sarcopenia on CT-scan and the frequency of adjuvant treatment needed in endometrial cancer patients
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: May 22, 2019)
  • Type of tumour [ Time Frame: 6 months ]
    To assess the relationship between body fat distribution on CT-scan and the type of tumour histology in endometrial cancer patients
  • Perioperative complications [ Time Frame: 10 years ]
    To determine the association between body fat distribution on CT-scan and perioperative complications in endometrial cancer patients
  • Successful surgery [ Time Frame: 10 years ]
    To determine the association between body fat distribution on CT-scan and the percentage of patients with successful surgery in endometrial cancer patients
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title CT Assessment of BMI in Endometrial Cancer Patients
Official Title Computed Tomography Assessment of Body Fat Distribution in Endometrial Cancer Patients
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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Endometrial cancer patients
Condition Endometrial Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 22, 2019) 		350
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 1, 2021
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Hannah Donkers 01872252037 hannah.donkers@nhs.net
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03962140
Other Study ID Numbers 2019.RCHT.39
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Royal Cornwall Hospitals Trust
Study Sponsor Royal Cornwall Hospitals Trust
Collaborators Not Provided
Investigators Not Provided
PRS Account Royal Cornwall Hospitals Trust
Verification Date June 2020

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