Colorectal Cancer ScreeningTOPAZNCT02754661
Colon Capsule Endoscopy (CCE) Versus Computed Tomographic Colonography (CTC) in the Identification of Colonic Polyps in a Screening Population.
A study testing COLON Capsule endoscopy and Computed Tomographic Colonography in people with Colorectal Cancer Screening, run by Medtronic - MITG at 13 sites in United States.
Trial summary
The primary objective of this multicenter, prospective, randomized study is to assess the diagnostic yield of Colon Capsule Endoscopy (CCE) versus Computed Tomographic Colonography (CTC) in a screening population. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer Screening
- What is being tested?
- COLON Capsule endoscopy and Computed Tomographic Colonography
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 13 sitesUnited States
- Study dates
- Sep 2016to 7 Aug 2018
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is between 50 and 75 years of age (for African Americans only, subject is between 45-75 years of age).
- Subject is classified as average risk per the American Gastroenterological Association Guidelines on Colorectal Cancer Screening: Individuals without a personal or family history of CRC or adenomas, inflammatory bowel disease, or high-risk genetic syndromes.
- Subject is willing and able to participate in the study procedures and to understand and sign the informed consent.
Who cannot join
- Subject with history of colorectal cancer or adenoma (including those identified by computed tomography [CT], optical colonoscopy [OC[, sigmoidoscopy, etc.).
- Subject with history of negative colonoscopy within 10 years, as these subjects would be defined as not requiring screening in this timeframe. For subjects with alternative screening methods, refer to applicable guidelines.
- Subject with currently suspected or diagnosed with hematochezia, melena, iron deficiency with or without anemia, or any other rectal bleeding, including positive fecal occult blood test of any variety.
- Subject with any current condition believed to have an increased risk of capsule retention such as suspected or known bowel obstruction, stricture, or fistula.
- Subject with current dysphagia or any swallowing disorder.
- Subject with current serious medical conditions that would increase the risk associated with CCE, CTC, or colonoscopy that are so severe that screening would have no benefit.
Show all 15Show fewer
- Subject with a cardiac pacemaker or other implanted electromedical device.
- Subject expected to undergo MRI examination within 7 days after ingestion of the capsule.
- Subject with clinical evidence of renal disease, including clinically significant laboratory abnormalities of renal function within the past 6 months, or at any time in the past if not tested within the last 6 months, defined as creatinine, blood urea nitrogen (BUN), and/or glomerular filtration rate (GFR) outside of the local laboratory reference range.
- Subject with a diagnosis of gastroparesis or small bowel or large bowel dysmotility.
- Subject with allergies or known contraindication to the medications or preparation agents used in the procedure as described in the relevant instructions for use.
- Subject has an estimated life expectancy of less than 6 months.
- Subject is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity).
- Subject is pregnant, suspected pregnant, or is actively breast-feeding. Females of child-bearing potential will be required to provide either a urine pregnancy test or serum pregnancy test as part of the participant's standard of care regardless of their participation in the study (except for subjects who are surgically sterile or are post-menopausal for at least two years).
- Subject has participated in an investigational drug or device research study within 30 days of enrollment that may interfere with the subject's safety or ability to participate in this study.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Asheville Gastroenterology Associates
Asheville, North Carolina, 28801
Loyola University Medical Center
Chicago, Illinois, 60153
Indiana University Hospital
Indianapolis, Indiana, 46202
Indianapolis Gastroenterology and Hepatology
Indianapolis, Indiana, 46237
Borland-Groover Clinic
Jacksonville, Florida, 32256
University of South Alabama
Mobile, Alabama, 36688
NYU
New York, New York, 10016
Columbia University
New York, New York, 10032
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Baystate Hospital
Springfield, Massachusetts, 01199
Clinical Research Professionals
St Louis, Missouri, 63141
Virginia Gastroenterology institute
Suffolk, Virginia, 23434
About this study
Official title: Multicenter, Prospective, Randomized Study Comparing the Diagnostic Yield of Colon Capsule Endoscopy Versus Computed Tomographic Colonography in a Screening Population
The primary objective of this multicenter, prospective, randomized study is to assess the diagnostic yield of Colon Capsule Endoscopy (CCE) versus Computed Tomographic Colonography (CTC) in a screening population.
Read the detailed description
This is a multicenter, prospective, randomized study to evaluate the efficacy of CCE versus CTC in the identification of colonic polyps in a screening population.
Subjects will be enrolled at up to 20 clinical sites in the United States. Subjects who meet the eligibility criteria will be screened by the gastroenterology site for study participation at a baseline visit which will also include a blood test for renal function (eGFR), and will be evaluated on the randomized procedure day (CCE versus CTC) and again on the day of both the blinded and unblinded OC procedures. Telephone follow-ups will be conducted 5 - 9 days after the CCE/CTC procedure and 5 - 9 days after the unblinded OC procedure to assess subject well-being and capture any Adverse Events (AEs), regardless of relationship to the CCE, CTC, or Optical colonoscopy (OC) procedures.
All CCE RAPID® videos and CTC images will be evaluated by local and central readers. All study analyses will be based on central reader results for both CCE and CTC. Two sets of central readers will be utilized, one set for reading of the CCE RAPID® videos and one set for reading the CTC studies. Both groups of readers will be experts in the reading process for their respective procedures. Readers will provide a report of their findings to the sponsor within 2 weeks of capsule ingestion or CTC procedure in order to allow subjects to return within 5 weeks capsule ingestion or CTC procedure to undergo confirmatory OC. The first OC procedure will be performed with the clinician blinded to the CCE or CTC results. Immediately following this blinded procedure, the clinician will review the CCE or CTC results report provided by the sponsor from the central readers, and a second unblinded OC procedure will be performed if there are discrepancies between the CCE/CTC findings and OC.
Colonoscopy must not be performed by the same person who conducts the local CCE reading, or anyone who has reviewed CCE/CTC results for that subject.
Bowel preparation regimens for all three procedure types will be standardized across sites.
- Conditions
- Colorectal Cancer Screening
- Being tested
- COLON Capsule endoscopy, Computed Tomographic Colonography
- Keywords
- Polyps; Capsule endoscopy; CT Colonography; Colonoscopy; Average risk patients for colorectal cancer screening
- Medical subject headings
- Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COLON Capsule endoscopyDevice
Computed Tomographic ColonographyDevice
| Study group | Role | What they receive |
|---|---|---|
| COLON Capsule endoscopy | Experimental | Subjects will be instructed to follow a detailed dietary and colon preparation regimen prior to and during the CCE procedure day. With the exception of Gastrografin, all colon preparation products will be standard colon cleansing products approved by the FDA.
Between 45 and 75 minutes after the final Polyethylene Glycol (PEG) ingestion, the subject will swallow the PillCam COLON Capsule with a cup of water.
If necessary, capsule position will be monitored to ensure adequate booster administration. Subjects will keep a timed diary of key preparation steps and bowel activity, including capsule excretion. Subjects will be allowed to leave the unit 10 hours after capsule ingestion if the capsule is not yet excreted. Subjects leaving before excretion will be instructed to disconnect the recorder at excretion or 12 hours after capsule ingestion (whichever comes first). Receives: Device: COLON Capsule endoscopy |
| Computed Tomographic Colonography | Active comparator | Subjects will be instructed to follow a detailed dietary and colon preparation regimen prior to and during the Computed Tomographic Colonography (CTC) procedure day.
The CTC procedure and study interpretation will be conducted in accordance with the ACR-SAR-SCBT-MR Practice Parameter for the Performance of CT Colonography in Adults. Colon insufflation will be performed with the subject in the lateral decubitus or supine position.With the subject in the supine position, a CT scout image will be taken to confirm adequate colon distention. If adequate bowel distention is not achieved, additional air will be insufflated into the colon. After scanning the subject in the supine position, the subject will be placed in the prone position, and additional CO2 will be administered. Subsequently, CT will be performed with the subject in the prone position. If a prone position is not possible for the subject, a left lateral decubitus position is preferred for optimal gas and fluid redistribution. Receives: Device: Computed Tomographic Colonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With an Actionable Lesion on CCE vs. CTC Confirmed by Optical Colonoscopy
Proportion of subjects shown to have an actionable lesion, defined as any polyp or mass lesion ≥6 mm.
Diagnostic yield of CCE/CTC will be calculated in relation to the confirmatory Optical colonoscopy results
Measured: 5-6 weeks from randomized procedure
Secondary outcomes (4)
Sensitivity of CCE Versus CTC in the Detection of Polyps ≥6 mm
Sensitivity (the percentage of patients with disease who test positive) assessed in relation to the confirmatory optical colonoscopy (OC) results on a "per subject" basis
Measured: 5-6 weeks from randomized procedure
Specificity of CCE Versus CTC in the Detection of Polyps ≥6 mm
Specificity (the percentage of patients without disease who test negative) assessed in relation to the confirmatory optical colonoscopy (OC) results on a "per subject" basis
Measured: 5-6 weeks from randomized procedure
Predictive Value of a Positive Test (PPV) of CCE Versus CTC in the Detection of Polyps ≥6 mm
Predictive value of a positive test (PPV) is the percentage of patients with positive tests who have disease assessed in relation to the confirmatory OC results on a "per subject" basis
Measured: 5-6 weeks from randomized procedure
Predictive Value of a Negative (NPV) of CCE Versus CTC in the Detection of Polyps ≥6 mm
Predictive value of a negative test (NPV) is the percentage of patients with negative tests who do not have disease, assessed in relation to the confirmatory OC results on a "per subject" basis.
Measured: 5-6 weeks from randomized procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startSep 2016
- Primary completion7 Aug 2018
- Study completion7 Aug 2018
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 Colorectal Cancer ScreeningStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brooks Cash, MD, Principal investigator, University of South Alabama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754661
- Sponsor's protocol ID
- COVGIC20543
- Other IDs
- MA-213
- Acronym
- TOPAZ
- Status last verified
- Aug 2019
- First submitted
- 25 Apr 2016
- Last updated
- 1 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Cash BD, Fleisher MR, Fern S, Rajan E, Haithcock R, Kastenberg DM, Pound D, Papageorgiou NP, Fernandez-Urien I, Schmelkin IJ, Rex DK. Multicentre, prospective, randomised study comparing the diagnostic yield of colon capsule endoscopy versus CT colonography in a screening population (the TOPAZ study). Gut. 2021 Nov;70(11):2115-2122. doi: 10.1136/gutjnl-2020-322578. Epub 2020 Dec 18.
PubMed 33443017
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective, Randomized Study Comparing the Diagnostic Yield of Colon Capsule Endoscopy Versus Computed Tomographic Colonography in a Screening Population
- ClinicalTrials.gov ID
- NCT02754661
- Acronym / sponsor ID
- TOPAZ / COVGIC20543
- Conditions
- Colorectal Cancer Screening
- Keywords
- Polyps; Capsule endoscopy; CT Colonography; Colonoscopy; Average risk patients for colorectal cancer screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- 7 Aug 2018 (actual)
- Study completion
- 7 Aug 2018 (actual)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Posted 1 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this multicenter, prospective, randomized study is to assess the diagnostic yield of Colon Capsule Endoscopy (CCE) versus Computed Tomographic Colonography (CTC) in a screening population.
Detailed description
This is a multicenter, prospective, randomized study to evaluate the efficacy of CCE versus CTC in the identification of colonic polyps in a screening population.
Subjects will be enrolled at up to 20 clinical sites in the United States. Subjects who meet the eligibility criteria will be screened by the gastroenterology site for study participation at a baseline visit which will also include a blood test for renal function (eGFR), and will be evaluated on the randomized procedure day (CCE versus CTC) and again on the day of both the blinded and unblinded OC procedures. Telephone follow-ups will be conducted 5 - 9 days after the CCE/CTC procedure and 5 - 9 days after the unblinded OC procedure to assess subject well-being and capture any Adverse Events (AEs), regardless of relationship to the CCE, CTC, or Optical colonoscopy (OC) procedures.
All CCE RAPID® videos and CTC images will be evaluated by local and central readers. All study analyses will be based on central reader results for both CCE and CTC. Two sets of central readers will be utilized, one set for reading of the CCE RAPID® videos and one set for reading the CTC studies. Both groups of readers will be experts in the reading process for their respective procedures. Readers will provide a report of their findings to the sponsor within 2 weeks of capsule ingestion or CTC procedure in order to allow subjects to return within 5 weeks capsule ingestion or CTC procedure to undergo confirmatory OC. The first OC procedure will be performed with the clinician blinded to the CCE or CTC results. Immediately following this blinded procedure, the clinician will review the CCE or CTC results report provided by the sponsor from the central readers, and a second unblinded OC procedure will be performed if there are discrepancies between the CCE/CTC findings and OC.
Colonoscopy must not be performed by the same person who conducts the local CCE reading, or anyone who has reviewed CCE/CTC results for that subject.
Bowel preparation regimens for all three procedure types will be standardized across sites.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COLON Capsule endoscopy | Experimental | Device: COLON Capsule endoscopySubjects will be instructed to follow a detailed dietary and colon preparation regimen prior to and during the CCE procedure day. With the exception of Gastrografin, all colon preparation products will be standard colon cleansing products approved by the FDA. Between 45 and 75 minutes after the final Polyethylene Glycol (PEG) ingestion, the subject will swallow the PillCam COLON Capsule with a cup of water. If necessary, capsule position will be monitored to ensure adequate booster administration. Subjects will keep a timed diary of key preparation steps and bowel activity, including capsule excretion. Subjects will be allowed to leave the unit 10 hours after capsule ingestion if the capsule is not yet excreted. Subjects leaving before excretion will be instructed to disconnect the recorder at excretion or 12 hours after capsule ingestion (whichever comes first). |
| Computed Tomographic Colonography | Active comparator | Device: Computed Tomographic ColonographySubjects will be instructed to follow a detailed dietary and colon preparation regimen prior to and during the Computed Tomographic Colonography (CTC) procedure day. The CTC procedure and study interpretation will be conducted in accordance with the ACR-SAR-SCBT-MR Practice Parameter for the Performance of CT Colonography in Adults. Colon insufflation will be performed with the subject in the lateral decubitus or supine position.With the subject in the supine position, a CT scout image will be taken to confirm adequate colon distention. If adequate bowel distention is not achieved, additional air will be insufflated into the colon. After scanning the subject in the supine position, the subject will be placed in the prone position, and additional CO2 will be administered. Subsequently, CT will be performed with the subject in the prone position. If a prone position is not possible for the subject, a left lateral decubitus position is preferred for optimal gas and fluid redistribution. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is between 50 and 75 years of age (for African Americans only, subject is between 45-75 years of age).
- Subject is classified as average risk per the American Gastroenterological Association Guidelines on Colorectal Cancer Screening: Individuals without a personal or family history of CRC or adenomas, inflammatory bowel disease, or high-risk genetic syndromes.
- Subject is willing and able to participate in the study procedures and to understand and sign the informed consent.
Key exclusion criteria (15 listed)
- Subject with history of colorectal cancer or adenoma (including those identified by computed tomography [CT], optical colonoscopy [OC[, sigmoidoscopy, etc.).
- Subject with history of negative colonoscopy within 10 years, as these subjects would be defined as not requiring screening in this timeframe. For subjects with alternative screening methods, refer to applicable guidelines.
- Subject with currently suspected or diagnosed with hematochezia, melena, iron deficiency with or without anemia, or any other rectal bleeding, including positive fecal occult blood test of any variety.
- Subject with any current condition believed to have an increased risk of capsule retention such as suspected or known bowel obstruction, stricture, or fistula.
- Subject with current dysphagia or any swallowing disorder.
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 |
|---|---|---|
| COLON Capsule endoscopy | Device | COLON Capsule endoscopy |
| Computed Tomographic Colonography | Device | Computed Tomographic Colonography |
Primary outcome
Number of Participants With an Actionable Lesion on CCE vs. CTC Confirmed by Optical Colonoscopy
Time frame: 5-6 weeks from randomized procedure
Proportion of subjects shown to have an actionable lesion, defined as any polyp or mass lesion ≥6 mm. Diagnostic yield of CCE/CTC will be calculated in relation to the confirmatory Optical colonoscopy results
4 secondary outcomes
Sensitivity of CCE Versus CTC in the Detection of Polyps ≥6 mm
Time frame: 5-6 weeks from randomized procedure
Specificity of CCE Versus CTC in the Detection of Polyps ≥6 mm
Time frame: 5-6 weeks from randomized procedure
Predictive Value of a Positive Test (PPV) of CCE Versus CTC in the Detection of Polyps ≥6 mm
Time frame: 5-6 weeks from randomized procedure
Predictive Value of a Negative (NPV) of CCE Versus CTC in the Detection of Polyps ≥6 mm
Time frame: 5-6 weeks from randomized procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33443017Cash BD, Fleisher MR, Fern S, Rajan E, Haithcock R, Kastenberg DM, Pound D, Papageorgiou NP, Fernandez-Urien I, Schmelkin IJ, Rex DK. Multicentre, prospective, randomised study comparing the diagnostic yield of colon capsule endoscopy versus CT colonography in a screening population (the TOPAZ study). Gut. 2021 Nov;70(11):2115-2122. doi: 10.1136/gutjnl-2020-322578. Epub 2020 Dec 18.
- 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.
Brooks Cash, MD principal investigator
University of South Alabama
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COLON Capsule endoscopy and Computed Tomographic Colonography in people with Colorectal Cancer Screening, run by Medtronic - MITG at 13 sites 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 15 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 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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 1 Oct 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?
Number of Participants With an Actionable Lesion on CCE vs. CTC Confirmed by Optical Colonoscopy (time frame: 5-6 weeks from randomized procedure). 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 NCT02754661, 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 1 Oct 2019.