Endometrial CancerNCT03962140
CT Assessment of BMI in Endometrial Cancer Patients
An observational study of Endometrial Cancer, run by Royal Cornwall Hospitals Trust at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Endometrial Cancer
- How many people
- 302 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2019to 31 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- Adult, Older adult
Study population: Endometrial cancer patients
Who may be able to join
- 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)
Who cannot join
- Women with concurrent cancer
- Women with unknown body mass index
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Computed Tomography Assessment of Body Fat Distribution in Endometrial Cancer Patients
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
- Conditions
- Endometrial Cancer
- Keywords
- Endometrial Cancer, CT-scan, Fat distribution, Obesity, Sarcopenia
- Medical subject headings
- Endometrial Neoplasms, Obesity, Sarcopenia
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start1 Aug 2019
- Primary completion1 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Cornwall Hospitals Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962140
- Sponsor's protocol ID
- 2019.RCHT.39
- Status last verified
- Sep 2021
- First submitted
- 17 Apr 2019
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computed Tomography Assessment of Body Fat Distribution in Endometrial Cancer Patients
- ClinicalTrials.gov ID
- NCT03962140
- Acronym / sponsor ID
- 2019.RCHT.39
- Conditions
- Endometrial Cancer
- Keywords
- Endometrial Cancer, CT-scan, Fat distribution, Obesity, Sarcopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Royal Cornwall Hospitals TrustUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 23 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Endometrial cancer patients
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- Women with concurrent cancer
- Women with unknown body mass index
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer, run by Royal Cornwall Hospitals Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Investigation of Patients with High BMI and Survival Rates (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.