Colon CancerNCT01572428
Narrow-Band Imaging Versus Standard White Light for the Detection of Serrated Lesions in the Proximal Colon
A study testing Inspection with Narrow-Band Imaging(NBI) and Standard White Light in people with Colon Cancer, run by Indiana University at 1 site in United States.
Trial summary
This is a study to determine if using Narrow-Band Imaging of the colon, rather than the usual white light on the colon, will improve the detection of a type of polyp called serrated. The polyps are called serrated because of their appearance under the microscope after they have been removed. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Inspection with Narrow-Band Imaging(NBI) and Standard White Light
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 898 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to 7 Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 50-85
- Intact colon and rectum
- American Society of Anesthesiology risk class 1, 2 or 3
Who cannot join
- No prior surgical resection of colon or rectum
Trial locations and contacts
1 site in 1 country.
United States1 site
Beltway Surgical Center
Indianapolis, Indiana, 46280
About this study
Official title: Randomized Controlled Trial Comparing the Use of Narrow-Band Imaging Versus Standard White Light for the Detection of Serrated Lesions in the Proximal Colon
This is a study to determine if using Narrow-Band Imaging of the colon, rather than the usual white light on the colon, will improve the detection of a type of polyp called serrated. The polyps are called serrated because of their appearance under the microscope after they have been removed. They tend to be located up high in the colon, far away from the rectum. They have been definitely shown to be a type of precancerous polyp and it is possible that using Narrow-Band Imaging will make it easier to see them, as they can be quite difficult to see with standard white light.
Read the detailed description
This is a randomized controlled trial comparing the use of Narrow-Band Imaging (illumination of the colon in blue light)versus standard white light for the detection of serrated lesions in the proximal colon (the colon proximal to the splenic flexure). Recent studies have indicated that colonoscopy is more effective in preventing cancer in the left side of the colon than the right side of the colon. The reasons for this difference may be partly biologic, in that a special group of polyps known as serrated polyps, particularly sessile serrated adenomas, are located primarily proximal to the splenic flexure. These lesions share molecular features with a group of cancers that occur primarily in the proximal colon. These molecular features include CpG island methylator phenotype (CIMP) and microsatellite instability. These lesions are endoscopically subtle in that they are often flat, have the same color as the surrounding mucosa, and are hard to differentiate from normal mucosa. Narrow-Band Imaging has anecdotally been used to highlight the appearance of these lesions. This study will test whether Narrow-Band Imaging increases the detection of serrated lesions in a randomized controlled trial.
- Conditions
- Colon Cancer
- Being tested
- Inspection with Narrow-Band Imaging(NBI), Standard White Light
- Keywords
- Proximal Colon Cancer, Serrated Colon Lesions, Narrow Band Imaging
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspection with Narrow-Band Imaging(NBI)Procedure or surgery
Also called Colonoscopy
Narrow-Band Imaging(NBI)of the colon rather than the standard white light in the inspection of the colon during colonoscopy.
Standard White LightProcedure or surgery
Also called Colonoscopy
Use of Standard White Light on the colon rather than Narrow-Band Imaging(NBI)in the inspection of the colon during a colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Narrow-Band Imaging (NBI) | Active comparator | Inspection with Narrow-Band Imaging(NBI) versus inspection with standard white light(usual care) Receives: Procedure: Inspection with Narrow-Band Imaging(NBI) |
| Standard White Light | Active comparator | Inspection with Standard White Light versus Narrow-Band Imaging(NBI) Receives: Procedure: Inspection with Narrow-Band Imaging(NBI); Procedure: Standard White Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Serrated Lesions Proximal to the Sigmoid Colon
Total quantity of serrated lesions found proximal to the sigmoid colon during colonoscopy.
Measured: During the colonoscopy procedure
Number of Serrated Lesions Proximal to the Sigmoid Colon Per Patient
Average number of polyps per patient that had serrated histology and were located proximal to the sigmoid colon (cecum to transverse colon).
Measured: During the colonoscopy procedure
Secondary outcomes (4)
Patients With 1 or More Serrated Lesions Proximal to the Sigmoid Colon
Patient had to have at least 1 polyp that had serrated histology and was located proximal to the sigmoid colon (cecum to transverse colon).
Measured: During the colonoscopy procedure
Total Number of Conventional Adenomas in Entire Colon
Total quantity of adenomas found during colonoscopy procedure.
Measured: During the colonoscopy procedure
Number of Conventional Adenomas Per Patient in Entire Colon
Average number of adenomas (located anywhere throughout the colon) found per patient.
Measured: During the colonoscopy procedure
Patients With 1 or More Conventional Adenomas
Patient had to have at least 1 polyp that was an adenoma.
Measured: During the colonoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startApr 2011
- Primary completion7 Jul 2014
- Study completion7 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 898 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Olympus
- Responsible party
- Principal investigator, Douglas K. Rex, Indiana University
- Investigators
- Douglas K Rex, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572428
- Sponsor's protocol ID
- 1012-17
- Status last verified
- Jun 2019
- First submitted
- 11 Jul 2011
- Last updated
- 8 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Rex DK, Clodfelter R, Rahmani F, Fatima H, James-Stevenson TN, Tang JC, Kim HN, McHenry L, Kahi CJ, Rogers NA, Helper DJ, Sagi SV, Kessler WR, Wo JM, Fischer M, Kwo PY. Narrow-band imaging versus white light for the detection of proximal colon serrated lesions: a randomized, controlled trial. Gastrointest Endosc. 2016 Jan;83(1):166-71. doi: 10.1016/j.gie.2015.03.1915. Epub 2015 May 5.
PubMed 25952085
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing the Use of Narrow-Band Imaging Versus Standard White Light for the Detection of Serrated Lesions in the Proximal Colon
- ClinicalTrials.gov ID
- NCT01572428
- Acronym / sponsor ID
- 1012-17
- Conditions
- Colon Cancer
- Keywords
- Proximal Colon Cancer, Serrated Colon Lesions, Narrow Band Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 898 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Olympus
- Study start
- Apr 2011
- Primary completion
- 7 Jul 2014 (actual)
- Study completion
- 7 Jul 2014 (actual)
- First posted
- 6 Apr 2012 (estimated)
- Results
- Posted 8 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to determine if using Narrow-Band Imaging of the colon, rather than the usual white light on the colon, will improve the detection of a type of polyp called serrated. The polyps are called serrated because of their appearance under the microscope after they have been removed. They tend to be located up high in the colon, far away from the rectum. They have been definitely shown to be a type of precancerous polyp and it is possible that using Narrow-Band Imaging will make it easier to see them, as they can be quite difficult to see with standard white light.
Detailed description
This is a randomized controlled trial comparing the use of Narrow-Band Imaging (illumination of the colon in blue light)versus standard white light for the detection of serrated lesions in the proximal colon (the colon proximal to the splenic flexure). Recent studies have indicated that colonoscopy is more effective in preventing cancer in the left side of the colon than the right side of the colon. The reasons for this difference may be partly biologic, in that a special group of polyps known as serrated polyps, particularly sessile serrated adenomas, are located primarily proximal to the splenic flexure. These lesions share molecular features with a group of cancers that occur primarily in the proximal colon. These molecular features include CpG island methylator phenotype (CIMP) and microsatellite instability. These lesions are endoscopically subtle in that they are often flat, have the same color as the surrounding mucosa, and are hard to differentiate from normal mucosa. Narrow-Band Imaging has anecdotally been used to highlight the appearance of these lesions. This study will test whether Narrow-Band Imaging increases the detection of serrated lesions in a randomized controlled trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narrow-Band Imaging (NBI) | Active comparator | Procedure: Inspection with Narrow-Band Imaging(NBI)Inspection with Narrow-Band Imaging(NBI) versus inspection with standard white light(usual care) |
| Standard White Light | Active comparator | Procedure: Inspection with Narrow-Band Imaging(NBI), Procedure: Standard White LightInspection with Standard White Light versus Narrow-Band Imaging(NBI) |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 50-85
- Intact colon and rectum
- American Society of Anesthesiology risk class 1, 2 or 3
Key exclusion criteria (1 listed)
- No prior surgical resection of colon or rectum
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 |
|---|---|---|
| Inspection with Narrow-Band Imaging(NBI)Also: ColonoscopyNarrow-Band Imaging(NBI)of the colon rather than the standard white light in the inspection of the colon during colonoscopy. | Procedure or surgery | Narrow-Band Imaging (NBI), Standard White Light |
| Standard White LightAlso: ColonoscopyUse of Standard White Light on the colon rather than Narrow-Band Imaging(NBI)in the inspection of the colon during a colonoscopy. | Procedure or surgery | Standard White Light |
Primary outcome
Total Number of Serrated Lesions Proximal to the Sigmoid Colon
Time frame: During the colonoscopy procedure
Total quantity of serrated lesions found proximal to the sigmoid colon during colonoscopy.
Number of Serrated Lesions Proximal to the Sigmoid Colon Per Patient
Time frame: During the colonoscopy procedure
Average number of polyps per patient that had serrated histology and were located proximal to the sigmoid colon (cecum to transverse colon).
4 secondary outcomes
Patients With 1 or More Serrated Lesions Proximal to the Sigmoid Colon
Time frame: During the colonoscopy procedure
Total Number of Conventional Adenomas in Entire Colon
Time frame: During the colonoscopy procedure
Number of Conventional Adenomas Per Patient in Entire Colon
Time frame: During the colonoscopy procedure
Patients With 1 or More Conventional Adenomas
Time frame: During the colonoscopy procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25952085Rex DK, Clodfelter R, Rahmani F, Fatima H, James-Stevenson TN, Tang JC, Kim HN, McHenry L, Kahi CJ, Rogers NA, Helper DJ, Sagi SV, Kessler WR, Wo JM, Fischer M, Kwo PY. Narrow-band imaging versus white light for the detection of proximal colon serrated lesions: a randomized, controlled trial. Gastrointest Endosc. 2016 Jan;83(1):166-71. doi: 10.1016/j.gie.2015.03.1915. Epub 2015 May 5.
Related trials for Colon Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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.
Douglas K Rex, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspection with Narrow-Band Imaging(NBI) and Standard White Light in people with Colon Cancer, run by Indiana University at 1 site in United States.
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 3 inclusion and 1 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 8 Aug 2019. 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 States. 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. 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?
Yes. Results are posted in the registry (first posted 8 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Number of Serrated Lesions Proximal to the Sigmoid Colon (time frame: During the colonoscopy procedure). The study lists 2 primary outcomes in all. 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 NCT01572428, 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 8 Aug 2019.