Colorectal Cancer Screening
Conditions
Keywords
Polyps; Capsule endoscopy; CT Colonography; Colonoscopy; Average risk patients for colorectal cancer screening
Brief 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.
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.
Interventions
DEVICECOLON Capsule endoscopy
DEVICEComputed Tomographic Colonography
Sponsors
Medtronic - MITG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subject is between 50 and 75 years of age (for African Americans only, subject is between 45-75 years of age). 2. 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. 3. Subject is willing and able to participate in the study procedures and to understand and sign the informed consent.
Exclusion criteria
1. Subject with history of colorectal cancer or adenoma (including those identified by computed tomography \[CT\], optical colonoscopy \[OC\[, sigmoidoscopy, etc.). 2. 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. 3. 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. 4. Subject with any current condition believed to have an increased risk of capsule retention such as suspected or known bowel obstruction, stricture, or fistula. 5. Subject with current dysphagia or any swallowing disorder. 6. 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. 7. Subject with a cardiac pacemaker or other implanted electromedical device. 8. Subject expected to undergo MRI examination within 7 days after ingestion of the capsule. 9. 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. 10. Subject with a diagnosis of gastroparesis or small bowel or large bowel dysmotility. 11. Subject with allergies or known contraindication to the medications or preparation agents used in the procedure as described in the relevant instructions for use. 12. Subject has an estimated life expectancy of less than 6 months. 13. Subject is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity). 14. 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). 15. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With an Actionable Lesion on CCE vs. CTC Confirmed by Optical Colonoscopy | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of CCE Versus CTC in the Detection of Polyps ≥6 mm | 5-6 weeks from randomized procedure | 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 |
| Specificity of CCE Versus CTC in the Detection of Polyps ≥6 mm | 5-6 weeks from randomized procedure | 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 |
| Predictive Value of a Positive Test (PPV) of CCE Versus CTC in the Detection of Polyps ≥6 mm | 5-6 weeks from randomized procedure | 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 |
| Predictive Value of a Negative (NPV) of CCE Versus CTC in the Detection of Polyps ≥6 mm | 5-6 weeks from randomized procedure | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| COLON Capsule Endoscopy Subjects who had colon capsule endoscopy followed by optical colonoscopy within 5-6 weeks. | 145 |
| Computed Tomographic Colonography Subjects who had Computed Tomographic Colonography followed by optical colonoscopy within 5-6 weeks. | 141 |
| Total | 286 |
Baseline characteristics
| Characteristic | COLON Capsule Endoscopy | Computed Tomographic Colonography | Total |
|---|---|---|---|
| Age, Customized | 55.3 year | 56.0 year | 55.7 year |
| BMI (Body Mass Index) | 32.2 kg/m^2 | 30.2 kg/m^2 | 31.2 kg/m^2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 7 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 138 Participants | 133 Participants | 271 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 33 Participants | 23 Participants | 56 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 109 Participants | 115 Participants | 224 Participants |
| Region of Enrollment United States | 145 participants | 141 participants | 286 participants |
| Sex: Female, Male Female | 92 Participants | 73 Participants | 165 Participants |
| Sex: Female, Male Male | 53 Participants | 68 Participants | 121 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 145 | 0 / 141 |
| other Total, other adverse events | 4 / 145 | 8 / 141 |
| serious Total, serious adverse events | 2 / 145 | 1 / 141 |
Outcome results
Primary
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
Time frame: 5-6 weeks from randomized procedure
Population: Per protocol Analysis set (PPAS) is comprised of randomized subjects without major protocol deviations (violations with significant impact on subject outcomes) and who don't meet any of the following criteria: Subject withdraws, Capsules remained in the stomach/SB during the entire procedure, colonoscopy could not be done, technical failure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COLON CAPSULE ENDOSCOPY | Number of Participants With an Actionable Lesion on CCE vs. CTC Confirmed by Optical Colonoscopy | 34 Participants |
| Computed Tomographic Colonography | Number of Participants With an Actionable Lesion on CCE vs. CTC Confirmed by Optical Colonoscopy | 11 Participants |
Secondary
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.
Time frame: 5-6 weeks from randomized procedure
Population: Per protocol Analysis set (PPAS) is comprised of randomized subjects without major protocol deviations (violations with significant impact on subject outcomes) and who don't meet any of the following criteria: Subject withdraws, Capsules remained in the stomach/SB during the entire procedure, colonoscopy could not be done, technical failure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COLON CAPSULE ENDOSCOPY | Predictive Value of a Negative (NPV) of CCE Versus CTC in the Detection of Polyps ≥6 mm | 77 Participants |
| Computed Tomographic Colonography | Predictive Value of a Negative (NPV) of CCE Versus CTC in the Detection of Polyps ≥6 mm | 86 Participants |
p-value: 0.003490% CI: [-0.0371, 0.1585]Farrington-Manning test
Secondary
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
Time frame: 5-6 weeks from randomized procedure
Population: Per protocol Analysis set is comprised of all randomized subjects without major protocol deviations (violations that may have a significant impact on subject outcomes) and who don't meet any of the following criteria: Subject withdraws, Capsules remained in the stomach/SB during the entire procedure, colonoscopy could not be done, technical failure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COLON CAPSULE ENDOSCOPY | Predictive Value of a Positive Test (PPV) of CCE Versus CTC in the Detection of Polyps ≥6 mm | 34 Participants |
| Computed Tomographic Colonography | Predictive Value of a Positive Test (PPV) of CCE Versus CTC in the Detection of Polyps ≥6 mm | 11 Participants |
p-value: 0.09390% CI: [-0.1249, 0.1249]Farrington-Manning test
Secondary
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
Time frame: 5-6 weeks from randomized procedure
Population: Per protocol Analysis (PPAS) set is comprised of randomized subjects without major protocol deviations (violations with significant impact on subject outcomes) and who don't meet any of the following criteria: Subject withdraws, Capsules remained in the stomach/SB during the entire procedure, colonoscopy could not be done, technical failure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COLON CAPSULE ENDOSCOPY | Sensitivity of CCE Versus CTC in the Detection of Polyps ≥6 mm | 34 Participants |
| Computed Tomographic Colonography | Sensitivity of CCE Versus CTC in the Detection of Polyps ≥6 mm | 11 Participants |
p-value: <0.000190% CI: [0.203, 0.5434]Farrington-Manning test
Secondary
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
Time frame: 5-6 weeks from randomized procedure
Population: Per protocol Analysis (PPAS) set is comprised of randomized subjects without major protocol deviations (violations with significant impact on subject outcomes) and who don't meet any of the following criteria: Subject withdraws, Capsules remained in the stomach/SB during the entire procedure, colonoscopy could not be done, technical failure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COLON CAPSULE ENDOSCOPY | Specificity of CCE Versus CTC in the Detection of Polyps ≥6 mm | 77 Participants |
| Computed Tomographic Colonography | Specificity of CCE Versus CTC in the Detection of Polyps ≥6 mm | 86 Participants |
p-value: 0.01990% CI: [-0.0847, 0.0327]Farrington-Manning test