CT Colonography as the Initial Diagnostic Imaging Tool for Patients With Suspected Colorectal Cancer

NCT02820389 | Unknown DMC

• 1 other identifier: Colon CT study
• Study Type: observational
• Target: 246
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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)

  3 months following the initial imaging modality (either CTC or Optical Colonoscopy)

• 6-month cost-effectiveness analysis per patient undergoing either CTC or Optical

  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)

  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)

  3 months

Study Arms (2)

Optical colonoscopy

Patients with suspected colorectal cancer will undergo optical colonoscopy as the initial imaging modality.

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.

Procedure: CTC

Interventions

Optical colonoscopy PROCEDURE

Patients with suspected colorectal cancer in this group will undergo Optical Colonoscopy as the initial imaging modality.

Optical colonoscopy

CTC PROCEDURE

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.

CT Colonography

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College London: collaborator

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Nyree Griffin, MD

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bharti Malhotra, MSc

CONTACT

bharti.malhotra@kcl.ac.uk

Tiago Rua, MSc

CONTACT

tiago.rua@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2016
• First Posted: July 1, 2016
• Study Start: June 14, 2016
• Primary Completion: March 1, 2018
• Study Completion: September 1, 2018
• Last Updated: August 8, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)