Cancer of ColonNCT04198025
Psoas Density in Colorectal Cancer
An observational study of Cancer of Colon, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Colorectal cancer (CRC) is the 3rd most common cancer worldwide. In the UK, CRC is the 4th most common cancer accounting for 12% of cancers diagnosed each year with approximately 41,300 new cases diagnosed in 2014. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Colon
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2020to 1 Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Retrospective analysis of patients (>18 years old) having undergone curative colorectal resection for cancer (between 31st Aug 2013 - 31st Aug 2019) in one if this multicentre study sites. All patients must have undergone preoperative CT scan with contrast.
Who may be able to join
- Patient criteria:
- Having a major colorectal resection for the treatment of cancer
- Elective or emergency surgery
- Adults, defined as age ≥18 years of age (no maximum limit)
- Had a preoperative CT scan of the abdomen with contrast (portal venous phase)
- Operation performed between 31st Aug 2013 - 31st Aug 2019
Who cannot join
- Not having a preoperative CT scan with contrast
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Graduate Entry Medicine, Royal Derby Hospital
Derby, Derbyshire, DE22 3DT
About this study
Official title: Evaluating the Association Between Psoas Density Measurement on Preoperative CT Imaging and Postoperative Outcomes
Colorectal cancer (CRC) is the 3rd most common cancer worldwide. In the UK, CRC is the 4th most common cancer accounting for 12% of cancers diagnosed each year with approximately 41,300 new cases diagnosed in 2014. Surgery remains the only treatment option that can reliably achieve cure from colorectal cancer and thus nearly 20,000 major bowel resections are performed for this yearly in the UK. Surgery for these cancers however carries risk of major complications and potentially death. Selecting appropriate patients for surgery remains a challenge to cancer teams.
Risk factors exist for complications after surgery for CRC, many of which can be assessed and discussed with the patient prior to surgery, so that any decision to operate is with fully informed consent from the patient. Increasing attention is being paid to a patient's frailty or fitness as one of these risk factors. Our centre has previously shown that measuring the cross-sectional area of the psoas muscle (a large muscle near the spine) from preoperative imaging could predict major complications in colorectal cancer patients (Jones 2015), however specialist software and patient height is required to make this calculation. More recently we have demonstrated that the measurement of the psoas muscle density on preoperative imaging (i.e. routine CT scans that all patients have before surgery to plan treatment), may potentially be useful to predict which patients are at most risk of a major complication (Herrod 2019). If this finding holds true when tested on a larger scale, it could be used to help surgical teams make the decision on whether to offer surgical resection, what kind of operations to perform, how to best support individuals undergoing operation and to ensure that the patient has the most information available to decide what risk they are at by having major surgery.
- Conditions
- Cancer of Colon
- Keywords
- psoas muscle density, frailty
- Medical subject headings
- Colonic Neoplasms, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients who underwent colorectal resection | Patients in this observational study will have undergone CT scan as routine work up prior to resection of elective colorectal cancer. Psoas muscle density will be measured (in Hounsfield units from CT images) at lumbar vertebral level L3. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of post operative complications (Clavien-Dindo grade 3-4) during inpatient hospital stay.
Recorded post operative complications requiring intervention during post operative stay until initial discharge from hospital.
Measured: Through study completion, an average of 10 days.
Secondary outcomes (3)
Post operative length of stay
Number of days
Measured: Through study completion, usually between 6-10 days.
Mortality
Recorded patient death
Measured: Up to 5 year follow up from operation
Post operative complications beyond hospital discharge.
Recorded post operative complications (including re-operation or recurrence) until discharge from surgical clinic or date of record review.
Measured: From hospital discharge to record review (i.e. 30 days, 90 days, 2 - 5 year follow up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start1 Jan 2020 (estimated)
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of ColonStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198025
- Sponsor's protocol ID
- Psoas Muscle Density
- Status last verified
- Oct 2019
- First submitted
- 19 Nov 2019
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Association Between Psoas Density Measurement on Preoperative CT Imaging and Postoperative Outcomes
- ClinicalTrials.gov ID
- NCT04198025
- Acronym / sponsor ID
- Psoas Muscle Density
- Conditions
- Cancer of Colon
- Keywords
- psoas muscle density, frailty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 13 Dec 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.
Colorectal cancer (CRC) is the 3rd most common cancer worldwide. In the UK, CRC is the 4th most common cancer accounting for 12% of cancers diagnosed each year with approximately 41,300 new cases diagnosed in 2014. Surgery remains the only treatment option that can reliably achieve cure from colorectal cancer and thus nearly 20,000 major bowel resections are performed for this yearly in the UK. Surgery for these cancers however carries risk of major complications and potentially death. Selecting appropriate patients for surgery remains a challenge to cancer teams.
Risk factors exist for complications after surgery for CRC, many of which can be assessed and discussed with the patient prior to surgery, so that any decision to operate is with fully informed consent from the patient. Increasing attention is being paid to a patient's frailty or fitness as one of these risk factors. Our centre has previously shown that measuring the cross-sectional area of the psoas muscle (a large muscle near the spine) from preoperative imaging could predict major complications in colorectal cancer patients (Jones 2015), however specialist software and patient height is required to make this calculation. More recently we have demonstrated that the measurement of the psoas muscle density on preoperative imaging (i.e. routine CT scans that all patients have before surgery to plan treatment), may potentially be useful to predict which patients are at most risk of a major complication (Herrod 2019). If this finding holds true when tested on a larger scale, it could be used to help surgical teams make the decision on whether to offer surgical resection, what kind of operations to perform, how to best support individuals undergoing operation and to ensure that the patient has the most information available to decide what risk they are at by having major surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent colorectal resection | – | –Patients in this observational study will have undergone CT scan as routine work up prior to resection of elective colorectal cancer. Psoas muscle density will be measured (in Hounsfield units from CT images) at lumbar vertebral level L3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective analysis of patients (>18 years old) having undergone curative colorectal resection for cancer (between 31st Aug 2013 - 31st Aug 2019) in one if this multicentre study sites. All patients must have undergone preoperative CT scan with contrast.
Key inclusion criteria (6 listed)
- Having a major colorectal resection for the treatment of cancer
- Elective or emergency surgery
- Adults, defined as age ≥18 years of age (no maximum limit)
- Had a preoperative CT scan of the abdomen with contrast (portal venous phase)
- Operation performed between 31st Aug 2013 - 31st Aug 2019
Key exclusion criteria (1 listed)
- Not having a preoperative CT scan with contrast
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
Number of post operative complications (Clavien-Dindo grade 3-4) during inpatient hospital stay.
Time frame: Through study completion, an average of 10 days.
Recorded post operative complications requiring intervention during post operative stay until initial discharge from hospital.
3 secondary outcomes
Post operative length of stay
Time frame: Through study completion, usually between 6-10 days.
Mortality
Time frame: Up to 5 year follow up from operation
Post operative complications beyond hospital discharge.
Time frame: From hospital discharge to record review (i.e. 30 days, 90 days, 2 - 5 year follow up).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Individual participant dataSharing planned: No
Related trials for Cancer of Colon
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1/2
Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors
Advanced Solid Tumors, Metastatic Solid Tumors
Recruiting
Distance-Based Exercise to Preserve Function and Prevent Disability
Localized Malignant Solid Neoplasm, Anal Cancer
Recruiting
Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays
Ampulla of Vater Carcinoma, Appendix Carcinoma
RecruitingPhase 2
Gemcitabine, Cisplatin, Nab-paclitaxel (GAP) and Cemiplimab for Locally Advanced Biliary Tract Cancer (BTC)
Colon and Rectal Cancer
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.
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 Cancer of Colon, run by University of Nottingham 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 6 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Dec 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan N Lund, MD (01332 340131, jon.lund@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of post operative complications (Clavien-Dindo grade 3-4) during inpatient hospital stay. (time frame: Through study completion, an average of 10 days.). 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 13 Dec 2019.