Colon CancerNCT02876133
Narrow Band Imaging Versus White Light for Colonoscopy Serrate Lesions Detection
A study testing narrow band imaging withdrawal and white light withdrawal in people with Colon Cancer and Colon Sessile Serrated Adenoma/Polyp, run by Hospital Beatriz Ângelo at 3 sites in Portugal.
Trial summary
Colorectal cancer (CRC) is a leading cause of cancer death and its' incidence is rising in most European countries. Colonoscopy has been shown to reduce CRC incidence, however its effectiveness depends on the sensitivity to detect pre-malignant lesions. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer, Colon Sessile Serrated Adenoma/Polyp
- What is being tested?
- narrow band imaging withdrawal and white light withdrawal
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 987 participants
- Where
- 3 sitesPortugal
- Study dates
- Nov 2016to Aug 2019
- Phase
- Interventional
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective colonoscopies
Who cannot join
- known polyposis syndromes
- primary sclerosing cholangitis
- inflammatory bowel disease
- personal colorectal cancer history
Trial locations and contacts
3 sites in 1 country.
Alexandre O Ferreira, MD contact
Portugal3 sites, 3 recruiting
- Recruiting
Hospital Beatriz Ângelo
Loures
Alexandre O Ferreira, MD, alex.gastrohep@gmail.com
Alexandre O Ferreira, MD
- Not yet recruiting
Centro Hospitalar do Porto
Porto
Ricardo M Pinto, MD, PhD, ricardomarcospinto@sapo.pt
Ricardo M Pinto, MD, PhD
- Not yet recruiting
Instituto Português de Oncologia do Porto
Porto
Mario D Ribeiro, MD, PhD, mdinisribeiro@gmail.com
Diogo Libânio, MD
About this study
Official title: Improving Colorectal Cancer Screening: Using Narrow Band Imaging for Colonic Sessile Serrated Lesions
Colorectal cancer (CRC) is a leading cause of cancer death and its' incidence is rising in most European countries. Colonoscopy has been shown to reduce CRC incidence, however its effectiveness depends on the sensitivity to detect pre-malignant lesions.
Our aim is to evaluate narrow band imaging (NBI) during colonoscopy and serum miRNAs as novel tools for the early detection of colonic sessile serrated lesions (SSL). The investigators will perform a multicenter-randomized-controlled-trial to study the role of NBI in SSL detection.
- Conditions
- Colon Cancer, Colon Sessile Serrated Adenoma/Polyp
- Being tested
- narrow band imaging withdrawal, white light withdrawal
- Medical subject headings
- Colonic Neoplasms, Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
narrow band imaging withdrawalDevice
colonoscope withdrawal and mucosal inspection performed under narrow band imaging
white light withdrawalDevice
colonoscope withdrawal and mucosal inspection performed under white light imaging
| Study group | Role | What they receive |
|---|---|---|
| Narrow band imaging withdrawal | Experimental | colonoscope withdrawal and mucosal inspection performed under narrow band imaging Receives: Device: narrow band imaging withdrawal |
| white light withdrawal | Placebo comparator | colonoscope withdrawal and mucosal inspection performed under white light imaging Receives: Device: white light withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
average number of serrated lesions ≥10 mm detected per colonoscopy
Measured: immediate
Secondary outcomes (7)
Serrated class lesions detection rate
number of patients with at least 1 lesion/total number of participants
Measured: immediate
Serrated lesions <10 mm detected per colonoscopy
Measured: immediate
SSL detection rate
histologically defined according to the WHO criteria
Measured: immediate
Adenoma detection rate
number of patients with at least 1 adenoma/total number of participants
Measured: immediate
Adenomas detected per colonoscopy
Measured: immediate
Advanced (malignant) adenocarcinoma detection rate
Measured: immediate
Incidence of procedure related adverse events
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startNov 2016
- Primary completionAug 2019 (estimated)
- Study completionAug 2019 (estimated)
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 Colon 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 987 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Beatriz Ângelo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandre Ferreira, Hospital Beatriz Ângelo
- Investigators
- Alexandre O Ferreira, MD, Principal investigator, Hospital Beatriz Ângelo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876133
- Sponsor's protocol ID
- 176
- Status last verified
- Sep 2018
- First submitted
- 18 Aug 2016
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Rex DK, Ahnen DJ, Baron JA, Batts KP, Burke CA, Burt RW, Goldblum JR, Guillem JG, Kahi CJ, Kalady MF, O'Brien MJ, Odze RD, Ogino S, Parry S, Snover DC, Torlakovic EE, Wise PE, Young J, Church J. Serrated lesions of the colorectum: review and recommendations from an expert panel. Am J Gastroenterol. 2012 Sep;107(9):1315-29; quiz 1314, 1330. doi: 10.1038/ajg.2012.161. Epub 2012 Jun 19.
PubMed 22710576
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Colorectal Cancer Screening: Using Narrow Band Imaging for Colonic Sessile Serrated Lesions
- ClinicalTrials.gov ID
- NCT02876133
- Acronym / sponsor ID
- 176
- Conditions
- Colon Cancer, Colon Sessile Serrated Adenoma/Polyp
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 987 participants (estimated)
- Lead sponsor
- Hospital Beatriz ÂngeloUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 23 Aug 2016 (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.
Colorectal cancer (CRC) is a leading cause of cancer death and its' incidence is rising in most European countries. Colonoscopy has been shown to reduce CRC incidence, however its effectiveness depends on the sensitivity to detect pre-malignant lesions.
Our aim is to evaluate narrow band imaging (NBI) during colonoscopy and serum miRNAs as novel tools for the early detection of colonic sessile serrated lesions (SSL). The investigators will perform a multicenter-randomized-controlled-trial to study the role of NBI in SSL detection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narrow band imaging withdrawal | Experimental | Device: narrow band imaging withdrawalcolonoscope withdrawal and mucosal inspection performed under narrow band imaging |
| white light withdrawal | Placebo comparator | Device: white light withdrawalcolonoscope withdrawal and mucosal inspection performed under white light imaging |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for elective colonoscopies
Key exclusion criteria (4 listed)
- known polyposis syndromes
- primary sclerosing cholangitis
- inflammatory bowel disease
- personal colorectal cancer history
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 |
|---|---|---|
| narrow band imaging withdrawalcolonoscope withdrawal and mucosal inspection performed under narrow band imaging | Device | Narrow band imaging withdrawal |
| white light withdrawalcolonoscope withdrawal and mucosal inspection performed under white light imaging | Device | white light withdrawal |
Primary outcome
average number of serrated lesions ≥10 mm detected per colonoscopy
Time frame: immediate
7 secondary outcomes
Serrated class lesions detection rate
Time frame: immediate
Serrated lesions <10 mm detected per colonoscopy
Time frame: immediate
SSL detection rate
Time frame: immediate
Adenoma detection rate
Time frame: immediate
Adenomas detected per colonoscopy
Time frame: immediate
Advanced (malignant) adenocarcinoma detection rate
Time frame: immediate
Incidence of procedure related adverse events
Time frame: immediate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
- Background: PubMed 22710576Rex DK, Ahnen DJ, Baron JA, Batts KP, Burke CA, Burt RW, Goldblum JR, Guillem JG, Kahi CJ, Kalady MF, O'Brien MJ, Odze RD, Ogino S, Parry S, Snover DC, Torlakovic EE, Wise PE, Young J, Church J. Serrated lesions of the colorectum: review and recommendations from an expert panel. Am J Gastroenterol. 2012 Sep;107(9):1315-29; quiz 1314, 1330. doi: 10.1038/ajg.2012.161. Epub 2012 Jun 19.
- Individual participant dataSharing planned: No
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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.
Alexandre O Ferreira, MD contact
Alexandre O Ferreira, MD principal investigator
Hospital Beatriz Ângelo
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing narrow band imaging withdrawal and white light withdrawal in people with Colon Cancer and Colon Sessile Serrated Adenoma/Polyp, run by Hospital Beatriz Ângelo at 3 sites in Portugal.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Portugal. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandre O Ferreira, MD (alex.gastrohep@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
average number of serrated lesions ≥10 mm detected per colonoscopy (time frame: immediate). 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 NCT02876133, 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 26 Sep 2018.