Feasibility of Reduction in Right Sided Bowel Cancer Through Contrast Enhanced Colonoscopy
CONSCOP
A Feasibility Randomised Controlled Trial (RCT) of Contrast Enhanced vs Non-enhanced Colonscopy in Index Bowel Cancer Screening to Reduce Bowel Cancer Mortality
1 other identifier
interventional
1,320
1 country
1
Brief Summary
The Bowel Cancer Screening program was implemented to address the important issue of prevention and early detection of bowel cancer. Results from the first few years of screening and previous smaller studies show that while in its current form it will save many lives, there continue to be polyps and cancers in the upper large bowel (right side) that may be difficult to detect. There is some evidence that these types of polyps (serrated polyps) may be at least partly responsible for cancers missed at the initial colonoscopy and have a faster rate of growth to cancer compared to conventional polyps (adenomas). We propose to examine participants undergoing screening colonoscopy with the addition of a contrast dye ( a safe food colouring agent base already used in various bowel camera procedures in standard clinical practice). This has been shown to improve detection of conventional polyps significantly even though it is considered by some to be more time consuming (possibly taking a few minutes longer) and requiring specific training to undertake. We hope to study the feasibility of undertaking these procedures to improve detection and removal of these polyps within the bowel screening program and potentially inform further studies to assess the impact of improved detection and consequent potentially reduced incidence of interval or missed bowel cancers in longer term follow up. Thus the main aims of this feasibility study are to assess if this type of procedure would be feasible to implement and acceptable to participants, colonoscopists and the screening program and also assess any additional time or costs involved to inform the question of if a larger study should then be undertaken to conclusively prove or disprove the merits of this approach in terms of health economics, cancer detection and survival.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 colorectal-cancer
Started Nov 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2013
CompletedFirst Posted
Study publicly available on registry
October 30, 2013
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2017
CompletedOctober 29, 2018
October 1, 2018
2.7 years
October 7, 2013
October 25, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Procedure time and withdrawal time
1 year
Secondary Outcomes (1)
Number of people attending the screening
1 year
Other Outcomes (1)
Colonoscopy procedure completeness
1 year
Study Arms (2)
Colonoscopy without enhanced dye
PLACEBO COMPARATORno enhanced dye
Colonoscopy with enhanced dye
ACTIVE COMPARATORenhanced dye
Interventions
Eligibility Criteria
You may qualify if:
- All participants testing positive on Faecal Occult Blood Test (FOBT) in the screening program who are eligible and appropriate for an index screening colonoscopy will be offered participation in the study.
You may not qualify if:
- Any participants not deemed fit for colonoscopy on the screening program or undergoing alternative investigation such as CT Pneumocolon or minimal prep CT scan as their index procedure instead.
- Participants who have undergone previous colorectal surgery will be excluded from the study though their standard management in the screening program will continue unchanged.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lisette Nixonlead
Study Sites (1)
Wales Cancer Trials Unit
Cardiff, CF14 4YS, United Kingdom
Related Publications (1)
Hurt C, Ramaraj R, Farr A, Morgan M, Williams N, Philips CJ, Williams GT, Gardner G, Porter C, Sampson J, Hillier S, Heard H, Dolwani S; CONSCOP Clinical Research Consortium. Feasibility and economic assessment of chromocolonoscopy for detection of proximal serrated neoplasia within a population-based colorectal cancer screening programme (CONSCOP): an open-label, randomised controlled non-inferiority trial. Lancet Gastroenterol Hepatol. 2019 May;4(5):364-375. doi: 10.1016/S2468-1253(19)30035-4. Epub 2019 Mar 16.
PMID: 30885505DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Senior Trial Manager
Study Record Dates
First Submitted
October 7, 2013
First Posted
October 30, 2013
Study Start
November 1, 2014
Primary Completion
June 30, 2017
Study Completion
June 30, 2017
Last Updated
October 29, 2018
Record last verified: 2018-10