Colorectal CancerPhase 2CONSCOPNCT01972451
Feasibility of Reduction in Right Sided Bowel Cancer Through Contrast Enhanced Colonoscopy
A Phase 2 study testing Colonoscopy with enhanced dye in people with Colorectal Cancer, run by Lisette Nixon at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Colonoscopy with enhanced dye
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,320 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2014to 30 Jun 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Colorectal Cancer
- Being tested
- Colonoscopy with enhanced dye
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonoscopy with enhanced dyeProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Colonoscopy without enhanced dye | Placebo comparator | no enhanced dye Receives: Procedure: Colonoscopy with enhanced dye |
| Colonoscopy with enhanced dye | Active comparator | enhanced dye Receives: Procedure: Colonoscopy with enhanced dye |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure time and withdrawal time
Measured: 1 year
Secondary outcomes (1)
Number of people attending the screening
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2013 (estimated)
- Study startNov 2014
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lisette Nixon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lisette Nixon, Cardiff University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01972451
- Sponsor's protocol ID
- WCTU065
- Acronym
- CONSCOP
- Status last verified
- Oct 2018
- First submitted
- 7 Oct 2013
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30885505
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01972451
- Acronym / sponsor ID
- CONSCOP / WCTU065
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,320 participants (estimated)
- Lead sponsor
- Lisette NixonUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 30 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colonoscopy without enhanced dye | Placebo comparator | Procedure: Colonoscopy with enhanced dyeno enhanced dye |
| Colonoscopy with enhanced dye | Active comparator | Procedure: Colonoscopy with enhanced dyeenhanced dye |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colonoscopy with enhanced dye | Procedure or surgery | Colonoscopy with enhanced dye, Colonoscopy without enhanced dye |
Primary outcome
Procedure time and withdrawal time
Time frame: 1 year
1 secondary outcome
Number of people attending the screening
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Derived from this study: PubMed 30885505Hurt 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.
- Sponsor study websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Colonoscopy with enhanced dye in people with Colorectal Cancer, run by Lisette Nixon at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure time and withdrawal time (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01972451, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2018.