Clinical trial NCT02820389: CT Colonography as the Initial Diagnostic Imaging Tool for Patients With Suspected Colorectal Cancer
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: King's College London
First posted: 2016-07-01
Enrollment: 246
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with bowel symptoms consistent with suspected colorectal cancer undergoing CTC or Optical Colonoscopy as the initial imaging test.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Every adult patient over 40 years old, presenting with constipation or alternating change in bowel habits, with a differential diagnosis of suspected colorectal cancer.

Exclusion Criteria:

* 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;
* Patients already taking part in any clinical trial of an investigational medicinal product (CTIMP);
* Prisoners
* Patients who are not fluent in English.

Primary outcomes:
measure: 3-month cost analysis per patient undergoing either Optical Colonoscopy or CTC as the initial imaging modality (measured in £ per patient)
timeFrame: 3 months following the initial imaging modality (either CTC or Optical Colonoscopy)
Secondary outcomes:
measure: 6-month cost analysis per patient undergoing either Optical Colonoscopy or CTC as the initial imaging modality (measured in £ per patient)
timeFrame: 6 months following the initial imaging modality (either CTC or Optical Colonoscopy)
measure: 3-month cost-effectiveness analysis per patient undergoing either CTC or Optical Colonoscopy as the initial imaging modality (measured in £ per QALY)
timeFrame: 3 months following the initial imaging modality (either CTC or Optical Colonoscopy)
measure: 6-month cost-effectiveness analysis per patient undergoing either CTC or Optical
timeFrame: 6 months following the initial imaging modality (either CTC or Optical Colonoscopy)
measure: 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)
timeFrame: Day 0 (following the initial CTC scan)
measure: 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)
timeFrame: 3 months
measure: 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.
timeFrame: 3 months
measure: 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)
timeFrame: Day 0 (on the day of the CTC or Optical Colonoscopy scan)
measure: Patient satisfaction associated with both clinical pathways (i.e. using CTC or Optical Colonoscopy as the initial imaging scan)
timeFrame: 3 months
measure: Patient's self perceived quality of life - measured using EQ-5D-5L questionnaire
timeFrame: 3 months
measure: Cost per correctly diagnosed medium to large polyps (≥6mm) and colorectal cancer using CTC as the initial investigation (measured in £ per patient)
timeFrame: 3 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Nyree Griffin, MD
role: PRINCIPAL_INVESTIGATOR
References: