Feasibility of Reduction in Right Sided Bowel Cancer Through Contrast Enhanced Colonoscopy (CONSCOP)
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Colonoscopy with enhanced dye
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
- All participants attending for a one year surveillance colonoscopy if they have undergone an index screening colonoscopy as part of the study as per current guidelines for surveillance will also be offered inclusion
Exclusion Criteria:
- 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.
Sites / Locations
- Wales Cancer Trials Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Colonoscopy without enhanced dye
Colonoscopy with enhanced dye
Arm Description
no enhanced dye
enhanced dye
Outcomes
Primary Outcome Measures
Procedure time and withdrawal time
Secondary Outcome Measures
Number of people attending the screening
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01972451
Brief Title
Feasibility of Reduction in Right Sided Bowel Cancer Through Contrast Enhanced Colonoscopy
Acronym
CONSCOP
Official Title
A Feasibility Randomised Controlled Trial (RCT) of Contrast Enhanced vs Non-enhanced Colonscopy in Index Bowel Cancer Screening to Reduce Bowel Cancer Mortality
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lisette Nixon
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Colonoscopy without enhanced dye
Arm Type
Placebo Comparator
Arm Description
no enhanced dye
Arm Title
Colonoscopy with enhanced dye
Arm Type
Active Comparator
Arm Description
enhanced dye
Intervention Type
Procedure
Intervention Name(s)
Colonoscopy with enhanced dye
Primary Outcome Measure Information:
Title
Procedure time and withdrawal time
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of people attending the screening
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Colonoscopy procedure completeness
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
All participants attending for a one year surveillance colonoscopy if they have undergone an index screening colonoscopy as part of the study as per current guidelines for surveillance will also be offered inclusion
Exclusion Criteria:
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.
Facility Information:
Facility Name
Wales Cancer Trials Unit
City
Cardiff
ZIP/Postal Code
CF14 4YS
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
30885505
Citation
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.
Results Reference
derived
Links:
URL
https://www.cardiff.ac.uk/centre-for-trials-research/research/studies-and-trials/view/conscop
Description
Sponsor study website
Learn more about this trial
Feasibility of Reduction in Right Sided Bowel Cancer Through Contrast Enhanced Colonoscopy
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