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CT Assessment of BMI in Endometrial Cancer Patients

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ClinicalTrials.gov Identifier: NCT03962140
Recruitment Status : Not yet recruiting
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Royal Cornwall Hospitals Trust

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

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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
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans




Primary Outcome Measures :
  1. Survival [ Time Frame: 10 years ]
    To investigate the association between body fat distribution and sarcopenia on CT-scan and survival in endometrial cancer patients

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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

  2. Perioperative complications [ Time Frame: 10 years ]
    To determine the association between body fat distribution on CT-scan and perioperative complications in endometrial cancer patients

  3. 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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03962140


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

Sponsors and Collaborators
Royal Cornwall Hospitals Trust

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Responsible Party: Royal Cornwall Hospitals Trust
ClinicalTrials.gov Identifier: NCT03962140     History of Changes
Other Study ID Numbers: 2019.RCHT.39
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Royal Cornwall Hospitals Trust:
Endometrial Cancer
CT-scan
Fat distribution
Obesity
Sarcopenia

Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female