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

NCT ID: NCT02820389

Last Updated: 2017-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

246 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-14

Study Completion Date

2018-09-30

Brief Summary

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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

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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

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Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Optical colonoscopy

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

Optical colonoscopy

Intervention Type PROCEDURE

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

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.

CTC

Intervention Type 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.

Interventions

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Optical colonoscopy

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

Intervention Type PROCEDURE

CTC

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King's College London

OTHER

Sponsor Role collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nyree Griffin, MD

Role: PRINCIPAL_INVESTIGATOR

Guy's and St Thomas' NHS Foundation Trust

Locations

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Guy's and St Thomas' NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Bharti Malhotra, MSc

Role: CONTACT

Tiago Rua, MSc

Role: CONTACT

Facility Contacts

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Bharti Malhotra

Role: primary

Tiago Rua

Role: backup

Other Identifiers

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Colon CT study

Identifier Type: -

Identifier Source: org_study_id

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