Colorectal CancerCTCSNCT02820389
CT Colonography as the Initial Diagnostic Imaging Tool for Patients With Suspected Colorectal Cancer
An observational study of Colorectal Cancer, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study aims to evaluate whether the use of Computed Tomography Colonography (CTC) for patients with low to intermediate risk of suspected colorectal cancer decreases overall NHS costs and waiting times whilst increasing patient satisfaction compared to clinical practice with utilisation of Optical Colonoscopy. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Optical colonoscopy and CTC
- Type of treatment
- Surgery or procedure
- How many people
- 246 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jun 2016to Sep 2018
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with bowel symptoms consistent with suspected colorectal cancer undergoing CTC or Optical Colonoscopy as the initial imaging test.
Who may be able to join
- Every adult patient over 40 years old, presenting with constipation or alternating change in bowel habits, with a differential diagnosis of suspected colorectal cancer.
Who cannot join
- Patients presenting with anaemia;
- Patients presenting with diarrhoea only for more than 6 weeks;
- Patients presenting with rectal bleeding;
- Patients who have undergone a previous whole-colon examination in the past 6 months;
- Patients who have been referred for a whole-colon examination to follow up already diagnosed colorectal cancer;
- Patients lacking capacity to give consent or participate in the study;
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- Patients already taking part in any clinical trial of an investigational medicinal product (CTIMP);
- Prisoners
- Patients who are not fluent in English.
Trial locations and contacts
1 site in 1 country.
Bharti Malhotra, MSc contact
Tiago Rua, MSc contact
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's and St Thomas' NHS Foundation Trust
London
Bharti Malhotra, bharti.malhotra@kcl.ac.uk
Tiago Rua, tiago.rua@kcl.ac.uk
About this study
Official title: Observational Study to Compare the Utilisation of CT Colonography With Optical Colonoscopy as the First Diagnostic Imaging Tool in Patients With Suspected Colorectal Cancer
This study aims to evaluate whether the use of Computed Tomography Colonography (CTC) for patients with low to intermediate risk of suspected colorectal cancer decreases overall NHS costs and waiting times whilst increasing patient satisfaction compared to clinical practice with utilisation of Optical Colonoscopy.
Read the detailed description
Given the recent change in the NICE guidance for the cancer pathway referral for patients with suspected colorectal cancer (See NG12), there will be an increase in demand for optical colonoscopy. Optical colonoscopy is technically difficult, resource intensive and associated with complications; therefore the increased use of CT Colonography (CTC) should be considered as an alternative. The diagnostic efficacy of CTC, in comparison to optical colonoscopy, is well established and has been shown to be accurate for identifying malignancies and medium to large polyps (≥6mm) with a greater level of patient acceptability.
The use of CTC as the first diagnostic imaging tool would identify those patients who would benefit from further investigation (colonoscopy or flexible sigmoidoscopy) to occur on the same day, as well as ruling out those who do not require further testing. This would then ensure that colonoscopy capacity can be prioritised appropriately to support the increase in demand due to the NICE guidance changes.
- Conditions
- Colorectal Cancer
- Being tested
- Optical colonoscopy, CTC
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical colonoscopyProcedure or surgery
Patients with suspected colorectal cancer in this group will undergo Optical Colonoscopy as the initial imaging modality.
CTCProcedure or surgery
Patients with suspected colorectal cancer in this group will undergo Computed Tomography Colonography (CTC) as the initial imaging modality. Subsequent imaging might be required based on the findings from the CTC scan, i.e. patients with medium to large polyps or colorectal cancer will undergo Optical Colonoscopy as the second imaging test.
| Study group | Role | What they receive |
|---|---|---|
| Optical colonoscopy | Patients with suspected colorectal cancer will undergo optical colonoscopy as the initial imaging modality. Receives: Procedure: Optical colonoscopy | |
| CT Colonography | Patients with suspected colorectal cancer will undergo Computed Tomography Colonography (CTC) as the initial imaging modality. Subsequent imaging might be required based on the findings from the CTC scan. Receives: Procedure: CTC |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-month cost analysis per patient undergoing either Optical Colonoscopy or CTC as the initial imaging modality (measured in £ per patient)
The primary outcome of this study is to investigate whether the investigation of patients with suspected colorectal cancer using CTC as the first diagnostic imaging tool is cost-saving at 3 months compared to optical colonoscopy.
Measured: 3 months following the initial imaging modality (either CTC or Optical Colonoscopy)
Secondary outcomes (10)
6-month cost analysis per patient undergoing either Optical Colonoscopy or CTC as the initial imaging modality (measured in £ per patient)
This secondary outcome aims to investigate whether the investigation of patients with suspected colorectal cancer using CTC as the first diagnostic imaging tool is cost-saving at 6 months compared to optical colonoscopy.
Measured: 6 months following the initial imaging modality (either CTC or Optical Colonoscopy)
3-month cost-effectiveness analysis per patient undergoing either CTC or Optical Colonoscopy as the initial imaging modality (measured in £ per QALY)
This secondary objective is aimed at evaluating whether the use of CTC as the initial imaging modality for patients with suspected colorectal cancer is cost-effective at 3 months compared to the use of Optical Colonoscopy.
Measured: 3 months following the initial imaging modality (either CTC or Optical Colonoscopy)
6-month cost-effectiveness analysis per patient undergoing either CTC or Optical
This secondary objective is aimed at evaluating whether the use of CTC as the initial imaging modality for patients with suspected colorectal cancer is cost-effective at 6 months compared to the use of Optical Colonoscopy.
Measured: 6 months following the initial imaging modality (either CTC or Optical Colonoscopy)
Frequency of incidental findings using CTC as the initial diagnostic imaging tool (measured as a %, number of patients with incidental findings in CTC / number of CTC scans)
CTC has the potential to investigate other intra-abdominal organs that are not seen with optical colonoscopy. Hence, CTC scans might lead to extracolonic findings. This outcome aims to evaluate the percentage of CTC scans that lead to clinically significant findings.
Measured: Day 0 (following the initial CTC scan)
Likelihood ratio of CTC as the initial diagnostic imaging tool against the optical colonoscopy in patients with initial positive CTC findings for medium to large polyps and colorectal cancer (estimated using the p-value)
The likelihood ratio of CTC against colonoscopy in patients with initial positive CTC findings will be assessed using Colonoscopy as the gold standard.
Measured: 3 months
Time taken (measured in days) to reach a definitive diagnosis and first major treatment decision based on the the initial CTC scan in comparison to Optical Colonoscopy as the initial imaging modality.
This objective will measure the time elapsed from the referral to either Colonoscopy or CTC and the time: 1) the test is actually performed; 2) a definitive diagnosis is reached (Optical Colonoscopy will be considered the gold standard for patients presenting positive findings in the initial CTC); and 3) the treatment decision is reached.
Measured: 3 months
Do not Attend (DNA) or On the Day Cancellation rate associated with the pathway using Colonoscopy or CTC as the initial imaging test (measured as a percentage)
This objective aims to estimate the Do not Attend (DNA) or On the Day Cancellation (ODC) rate associated with the pathway using Colonoscopy or CTC as the initial imaging test. Given that the bowel preparation associated with CTC is easily tolerated, it is anticipated that the increase in CTC utilisation will lead to a decrease in DNA and ODC rates.
Measured: Day 0 (on the day of the CTC or Optical Colonoscopy scan)
Patient satisfaction associated with both clinical pathways (i.e. using CTC or Optical Colonoscopy as the initial imaging scan)
To evaluate and compare the levels of patient satisfaction associated with the two pathways: i) with CTC as the initial imaging scan; and ii) with Optical Colonoscopy as the initial imaging scan. Two patient satisfaction questionnaires (on the day and 3 months following the CTC/Optical Colonoscopy test) will be used to quantify patient satisfaction.
Measured: 3 months
Patient's self perceived quality of life - measured using EQ-5D-5L questionnaire
This objective aims to evaluate the patient's self-perceived quality of life associated with both pathways using a standard questionnaire (EQ-5D-5L).
Measured: 3 months
Cost per correctly diagnosed medium to large polyps (≥6mm) and colorectal cancer using CTC as the initial investigation (measured in £ per patient)
The second outcome is to evaluate the cost per correctly diagnosed medium to large polyps (≥6mm) and colorectal cancer using CTC as the initial investigation.
For patients with positive findings on CTC (either medium to large polyps and/or CRC), optical colonoscopy will be used as the comparator to assess whether the initial diagnosis with CTC was correct.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study start14 Jun 2016
- Primary completionMar 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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
- Prospective
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Nyree Griffin, MD, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820389
- Sponsor's protocol ID
- Colon CT study
- Acronym
- CTCS
- Status last verified
- Aug 2017
- First submitted
- 3 Jun 2016
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Compare the Utilisation of CT Colonography With Optical Colonoscopy as the First Diagnostic Imaging Tool in Patients With Suspected Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02820389
- Acronym / sponsor ID
- CTCS / Colon CT study
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 14 Jun 2016 (actual)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 1 Jul 2016 (estimated)
- 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 aims to evaluate whether the use of Computed Tomography Colonography (CTC) for patients with low to intermediate risk of suspected colorectal cancer decreases overall NHS costs and waiting times whilst increasing patient satisfaction compared to clinical practice with utilisation of Optical Colonoscopy.
Detailed description
Given the recent change in the NICE guidance for the cancer pathway referral for patients with suspected colorectal cancer (See NG12), there will be an increase in demand for optical colonoscopy. Optical colonoscopy is technically difficult, resource intensive and associated with complications; therefore the increased use of CT Colonography (CTC) should be considered as an alternative. The diagnostic efficacy of CTC, in comparison to optical colonoscopy, is well established and has been shown to be accurate for identifying malignancies and medium to large polyps (≥6mm) with a greater level of patient acceptability.
The use of CTC as the first diagnostic imaging tool would identify those patients who would benefit from further investigation (colonoscopy or flexible sigmoidoscopy) to occur on the same day, as well as ruling out those who do not require further testing. This would then ensure that colonoscopy capacity can be prioritised appropriately to support the increase in demand due to the NICE guidance changes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optical colonoscopy | – | Procedure: Optical colonoscopyPatients with suspected colorectal cancer will undergo optical colonoscopy as the initial imaging modality. |
| CT Colonography | – | Procedure: CTCPatients with suspected colorectal cancer will undergo Computed Tomography Colonography (CTC) as the initial imaging modality. Subsequent imaging might be required based on the findings from the CTC scan. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with bowel symptoms consistent with suspected colorectal cancer undergoing CTC or Optical Colonoscopy as the initial imaging test.
Key inclusion criteria (1 listed)
- Every adult patient over 40 years old, presenting with constipation or alternating change in bowel habits, with a differential diagnosis of suspected colorectal cancer.
Key exclusion criteria (9 listed)
- Patients presenting with anaemia;
- Patients presenting with diarrhoea only for more than 6 weeks;
- Patients presenting with rectal bleeding;
- Patients who have undergone a previous whole-colon examination in the past 6 months;
- Patients who have been referred for a whole-colon examination to follow up already diagnosed colorectal cancer;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical colonoscopyPatients with suspected colorectal cancer in this group will undergo Optical Colonoscopy as the initial imaging modality. | Procedure or surgery | Optical colonoscopy |
| CTCPatients with suspected colorectal cancer in this group will undergo Computed Tomography Colonography (CTC) as the initial imaging modality. Subsequent imaging might be required based on the findings from the CTC scan, i.e. patients with medium to large polyps or colorectal cancer will undergo Optical Colonoscopy as the second imaging test. | Procedure or surgery | CT Colonography |
Primary outcome
3-month cost analysis per patient undergoing either Optical Colonoscopy or CTC as the initial imaging modality (measured in £ per patient)
Time frame: 3 months following the initial imaging modality (either CTC or Optical Colonoscopy)
The primary outcome of this study is to investigate whether the investigation of patients with suspected colorectal cancer using CTC as the first diagnostic imaging tool is cost-saving at 3 months compared to optical colonoscopy.
10 secondary outcomes
6-month cost analysis per patient undergoing either Optical Colonoscopy or CTC as the initial imaging modality (measured in £ per patient)
Time frame: 6 months following the initial imaging modality (either CTC or Optical Colonoscopy)
3-month cost-effectiveness analysis per patient undergoing either CTC or Optical Colonoscopy as the initial imaging modality (measured in £ per QALY)
Time frame: 3 months following the initial imaging modality (either CTC or Optical Colonoscopy)
6-month cost-effectiveness analysis per patient undergoing either CTC or Optical
Time frame: 6 months following the initial imaging modality (either CTC or Optical Colonoscopy)
Frequency of incidental findings using CTC as the initial diagnostic imaging tool (measured as a %, number of patients with incidental findings in CTC / number of CTC scans)
Time frame: Day 0 (following the initial CTC scan)
Likelihood ratio of CTC as the initial diagnostic imaging tool against the optical colonoscopy in patients with initial positive CTC findings for medium to large polyps and colorectal cancer (estimated using the p-value)
Time frame: 3 months
Time taken (measured in days) to reach a definitive diagnosis and first major treatment decision based on the the initial CTC scan in comparison to Optical Colonoscopy as the initial imaging modality.
Time frame: 3 months
Do not Attend (DNA) or On the Day Cancellation rate associated with the pathway using Colonoscopy or CTC as the initial imaging test (measured as a percentage)
Time frame: Day 0 (on the day of the CTC or Optical Colonoscopy scan)
Patient satisfaction associated with both clinical pathways (i.e. using CTC or Optical Colonoscopy as the initial imaging scan)
Time frame: 3 months
Patient's self perceived quality of life - measured using EQ-5D-5L questionnaire
Time frame: 3 months
Cost per correctly diagnosed medium to large polyps (≥6mm) and colorectal cancer using CTC as the initial investigation (measured in £ per patient)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
- Individual participant dataSharing planned: No
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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.
Bharti Malhotra, MSc contact
Tiago Rua, MSc contact
Nyree Griffin, MD principal investigator
Guy's and St Thomas' NHS Foundation Trust
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 Colorectal Cancer, run by Guy's and St Thomas' NHS Foundation 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 1 inclusion and 9 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 8 Aug 2017. 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 Bharti Malhotra, MSc (bharti.malhotra@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-month cost analysis per patient undergoing either Optical Colonoscopy or CTC as the initial imaging modality (measured in £ per patient) (time frame: 3 months following the initial imaging modality (either CTC or Optical Colonoscopy)). 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 8 Aug 2017.