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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
| 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 :
- 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
| 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
| Contact: Hannah Donkers | 01872252037 | hannah.donkers@nhs.net |
Locations
| 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 |
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
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| Original Primary Outcome Measures |
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| Change History | |||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures |
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| 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 |
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| 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 | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
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:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 99 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts |
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| 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 |
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| 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 | ||||
