This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Colorectal Cancer and Pre-Cancerous Adenoma Non-Invasive Detection Test Study (NCT04739722), a na na study. The primary outcome is ColoSense Sensitivity for Colorectal Cancer (CRC).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04739722 |
| Phase | NA |
| Condition | Colorectal Cancer, Advanced Adenocarcinoma, Serrated Polyp |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 14263 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Geneoscopy, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
The record describes people enrolled in a prospective colorectal cancer screening test study. Enrollment was 14263. The listed conditions include colorectal cancer, advanced adenocarcinoma and serrated polyp. Further eligibility criteria and participant characteristics are not reported in the registry record.
Intervention
The test under evaluation was ColoSense, a multi-target stool RNA diagnostic test. The record says participants were evaluated with ColoSense before undergoing colonoscopy. Details of sample processing, test thresholds and how results were classified are not reported in the registry record.
Comparator
This was a single-group study, not a randomized comparison. Colonoscopy followed the stool test, but the record does not describe colonoscopy as a separate randomized treatment group. No like-for-like control arm is recorded.
Primary question
The primary endpoint was ColoSense sensitivity for colorectal cancer, measured as a count of participants over the timeframe of 120 days from stool sample collection. Sensitivity asks how often a test identifies the condition among people who have it according to a reference assessment. The numerical sensitivity result and its uncertainty are not reported in the registry record.
In practical statistical terms, the question is whether the test result agrees with the disease status established in the study’s diagnostic evaluation, particularly for participants with colorectal cancer. The record identifies colonoscopy as occurring after the stool test, but details of the reference standard, the endpoint calculation and the analysis population are not reported in the registry record. Those details matter because sensitivity depends on who is counted as having colorectal cancer and which test outcomes count as positive.
3. Trial Design
The registry describes a prospective analysis of ColoSense for colorectal cancer screening. The study is listed as completed, with a start date of 2021-04-12 and a primary completion date of 2022-10-27. Enrollment was 14263. The listed study model is single group, allocation is NA, and masking is none. The intervention is a diagnostic test rather than a treatment assigned to different arms.
All participants were evaluated with ColoSense before undergoing colonoscopy. This sequence is relevant to a diagnostic accuracy study because test results can be compared with a subsequent assessment of disease status. However, the detailed procedures for conducting or interpreting colonoscopy, the timing between the two assessments, and the handling of inconclusive results are not reported in the registry record.
A single-group diagnostic evaluation differs from a randomized trial that compares outcomes between assigned treatments. It can describe test performance in the evaluated participants, but it does not provide a randomized control group for estimating a treatment contrast. The record itself flags that the study is not a randomized comparison and that its arms are not a like-for-like control comparison.
The study is listed with four outcome measures, but the registry record does not report numerical results for the primary sensitivity endpoint in the information available. It lists zero analyses. The protocol, sample-size justification, planned statistical analysis, interim analyses, and detailed inclusion and exclusion criteria are not reported in the registry record. The record names Geneoscopy, Inc. as sponsor.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Of the 14,263 subjects enrolled in the CRC-PREVENT study, 8,920 completed all study requirements and 7,763 subjects were considered average-risk.
Overall Study
| Stage | Enrolled Subjects |
|---|---|
| STARTED | 14263 |
| COMPLETED | 7763 |
| NOT COMPLETED | 6500 |
Reasons for not completing this period:
| Reason | Enrolled Subjects |
|---|---|
| Lost to Follow-up | 5301 |
| Withdrawal by Subject | 42 |
| Non Average-risk | 1157 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Subjects were men and women, 45 years of age or older, inclusive, who are at average risk of developing colorectal cancer.
| Characteristic | Unit | Average Risk Subjects |
|---|---|---|
| Participants analysed | 7763 | |
| Age, Continuous | years | 55.3 (45 to 90) |
| Sex/Gender, Customized: Female | Participants | 4643 |
| Sex/Gender, Customized: Male | Participants | 3111 |
| Sex/Gender, Customized: Other | Participants | 9 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 500 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 7121 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 142 |
| Race/Ethnicity, Customized: American Indian / Alaskan Native | Participants | 64 |
| Race/Ethnicity, Customized: Asian | Participants | 307 |
| Race/Ethnicity, Customized: Black / African American | Participants | 821 |
| Race/Ethnicity, Customized: Native Hawaiian / Other Pacific Islander | Participants | 17 |
| Race/Ethnicity, Customized: White | Participants | 6268 |
| Race/Ethnicity, Customized: Other | Participants | 286 |
| Region of Enrollment: United States | participants | 7763 |
6. Primary Endpoint
The registry lists the primary outcome as ColoSense Sensitivity for Colorectal Cancer (CRC), measured over 120 days from stool sample collection.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is titled “ColoSense Sensitivity for Colorectal Cancer (CRC).” It is specified as a count of participants, with a timeframe of 120 days from stool sample collection. Sensitivity is a diagnostic accuracy measure: in general, it describes the fraction of people with the target condition who receive a positive result from the test being evaluated. The endpoint is therefore intended to assess detection among participants with colorectal cancer, rather than to compare treatment outcomes.
For a sensitivity estimate to be interpretable, the disease status used as the reference must be defined, and the rules for classifying test results must be clear. The registry states that participants underwent colonoscopy after ColoSense testing, but the exact reference-standard definition and the operational calculation of the endpoint are not reported in the registry record. The actual count, denominator, sensitivity estimate and confidence interval are also not reported in the registry record.
Diagnostic studies commonly report sensitivity alongside other measures, since one performance measure alone does not fully describe a test. The registry lists four outcome measures, but the other outcome titles and their results are not reported in the registry record. Accordingly, the primary endpoint identifies the study’s main diagnostic question, but the available record does not establish a numerical estimate of performance.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record establishes the study’s broad design and primary diagnostic question, but it does not report the numerical result for the primary sensitivity endpoint. Without the number of participants with colorectal cancer, the number classified as positive by ColoSense, and the endpoint estimate, the test’s sensitivity cannot be described quantitatively from the registry record. The record also does not report a confidence interval for this endpoint, so its statistical precision cannot be assessed.
Sensitivity is a conditional measure: it concerns test results among participants who have the target condition under the study’s reference definition. It is not the same as the proportion of all participants who test positive, nor does it by itself tell how likely a positive result is to represent disease in a screening population. Those questions require different information and, for some measures, the prevalence of disease in the evaluated population.
The single-group design is appropriate to distinguish from a randomized treatment comparison. The record does not describe a randomized control arm, and the stated study model is single group. Therefore, the study should be read as an evaluation of test performance in the enrolled participants, not as a trial estimating a causal difference between assigned interventions. No comparative effect estimate is reported in the registry record.
The sequence in which ColoSense was administered before colonoscopy is recorded, but the available information does not establish how blinded interpretation, discordant findings, or incomplete assessments were handled. These details can affect diagnostic accuracy estimates. They are not reported in the registry record, so the result cannot be independently appraised for those aspects using the record alone.
The safety entries list zero serious adverse events, one other adverse event and zero deaths in the Enrolled Subjects group. These are counts in the registry record; definitions, event descriptions and follow-up details are not reported in the registry record. They should not be treated as evidence about diagnostic sensitivity or as a comparison with another group.
Overall, the registry record supports a description of what the study set out to evaluate and how the test was used in relation to colonoscopy. It does not supply the primary numerical result, its uncertainty, or the analysis details needed to determine how robustly that result was estimated. Any interpretation should therefore remain limited to the recorded design, endpoint and safety counts.
9. Statistical Methods Explained
What does sensitivity describe?
In general, sensitivity is the proportion of people who have a target condition, under a chosen reference definition, who are classified as positive by the test being evaluated. It answers a conditional question about detection among those with the condition. It does not describe performance among people without the condition; specificity addresses that different question. Neither measure alone gives the probability that a particular test result corresponds to disease in a particular person.
For this study, the named target condition is colorectal cancer and the test is ColoSense. Colonoscopy is recorded as occurring after the stool test. However, the precise reference definition, rules for positive ColoSense results, and endpoint calculation are not reported in the registry record. Without those rules and the underlying counts, the sensitivity value cannot be reconstructed or interpreted in detail.
Why does the denominator matter?
A sensitivity estimate uses only participants classified as having the target condition by the reference approach. The denominator is therefore not automatically the total enrollment. A diagnostic study may enroll many people but have fewer participants with the target condition; the precision of sensitivity depends importantly on how many condition-positive participants contribute usable paired test and reference results. The number of such participants and the endpoint denominator are not reported in the registry record.
General statistical principle: a proportion is more uncertain when it is based on fewer observations, and a confidence interval communicates that uncertainty. A point estimate without an interval can give an incomplete impression of precision. Here, neither the point estimate nor its confidence interval is reported in the registry record, so no numerical precision assessment is possible.
What does the single-group design imply?
The registry identifies a single-group model and no randomized allocation. This is consistent with evaluating a diagnostic test in enrolled participants rather than assigning participants to competing treatment arms. A single-group design can estimate diagnostic performance when the test and reference assessments are defined and paired appropriately. It does not, by itself, create a randomized comparison of two interventions or remove all possible sources of selection and measurement bias.
General statistical principle: diagnostic accuracy estimates can be affected by the population studied, the reference standard, missing or indeterminate results, and differences in how test and reference findings are interpreted. These considerations are especially important when applying an estimate beyond the participants who were evaluated. The registry record does not report the detailed procedures needed to assess these issues.
What is the role of a confidence interval?
In general, a confidence interval gives a range of values compatible with the observed data under the statistical method used. A narrower interval indicates greater statistical precision under that method; it does not guarantee that the study population, measurement process or reference definition is free of bias. A confidence interval for sensitivity would help readers understand uncertainty around the estimated diagnostic performance. No such interval is reported in the registry record.
The record lists zero analyses. The statistical analysis plan, any prespecified handling of missing observations, and methods for calculating uncertainty are not reported in the registry record. Consequently, no particular interval method or adjustment should be attributed to the study.
How should planning illustrations be understood?
General explanation: sample-size calculations are planning exercises that describe the amount of information a future study might need under selected assumptions. They are not observed study outcomes, and they are not a substitute for reporting actual estimates and uncertainty. The record’s planning assumptions describe an illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect.
Those assumptions should not be mistaken for the design of this single-group diagnostic study. The record does not describe a randomized two-arm comparison, and no numerical planning outputs or trial-specific sample-size justification are reported in the registry record. Planning illustrations do not show that a study had a specified probability of detecting an effect after the data were observed; they are not observed power.
Over-dispersion is a general concern when variability in count data exceeds what a simple probability model assumes. In such settings, uncertainty can be understated if the extra variability is ignored. The primary endpoint is specified as a count of participants, but the registry does not report a fitted model, dispersion estimate or analysis method. It would therefore be inappropriate to claim that a particular model or correction was used.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists four outcome measures, while identifying ColoSense sensitivity for colorectal cancer as the primary endpoint. The titles and numerical results for the remaining outcome measures are not reported in the registry record. The record lists zero analyses, and a statistical analysis plan is not reported in the registry record.
Multiplicity refers generally to the interpretive challenge created when several outcomes or statistical tests are considered. If many tests are examined, the chance of at least one apparently unusual result can increase unless the analysis plan accounts for the multiple comparisons or clearly distinguishes confirmatory from exploratory analyses. The registry record does not report whether any multiplicity adjustment was planned or used. No adjustment should be inferred.
Missing data matter because participants without an interpretable test result, reference assessment or paired measurements may not contribute to a diagnostic accuracy estimate. The number of missing or indeterminate results, their handling, and any sensitivity analyses are not reported in the registry record. The record also does not report whether all enrolled participants were included in the primary analysis or define the primary analysis population.
These omissions limit assessment of how the stated endpoint was estimated and whether the estimate might depend on exclusions or incomplete assessments. The study’s prospective description and the recorded test-before-colonoscopy sequence do not, on their own, answer these analysis questions. The numerical primary endpoint result and its uncertainty are not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Enrolled Subjects | 0 | 14263 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Enrolled Subjects | 0 of 14263 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Enrolled Subjects | 1 of 14263 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Enrolled Subjects |
|---|---|---|
| Non-serious, Anticipated, Adverse Event | Product Issues | 1 of 14263 |
The registry lists safety information for the group titled Enrolled Subjects. It records 14263 participants at risk for serious adverse events and zero with a serious adverse event. For other adverse events, the at-risk count is 14263 and the affected count is one. Deaths are recorded as zero. These entries are counts, not comparative estimates.
The registry record does not report the event term or description for the one other adverse event, the definitions used for serious and other adverse events, or the method and duration of safety follow-up. It also does not report a comparator group for these safety counts. The entries should therefore be read as the recorded counts for this group, without assuming that they capture every possible event or allow comparison with another test or strategy.
These safety counts are separate from the primary diagnostic sensitivity endpoint. They do not indicate how often ColoSense detected colorectal cancer, and they do not establish the cause of an event. The record does not provide enough detail to interpret the clinical nature or timing of the one other adverse event.
12. What the Result Does, and Does Not, Mean
The study addresses a diagnostic question: how ColoSense performs for detecting colorectal cancer in the enrolled participants, with colonoscopy following the stool test. The registry identifies sensitivity as the primary endpoint and gives its timeframe as 120 days from stool sample collection. This information clarifies the intended focus of the study.
The registry record does not report a numerical sensitivity estimate, the relevant participant counts, or a confidence interval. Consequently, it does not support a quantitative statement about the test’s detection performance or the precision of that performance estimate. The absence of a numerical result in the record should not be interpreted as a particular result.
The single-group design also defines what the study can address. The record does not describe randomized assignment to competing approaches, so it does not provide a randomized comparison of interventions. The test was evaluated before colonoscopy, but detailed procedures for the reference assessment and analysis are not reported in the registry record. These limits matter when judging how well the endpoint can be interpreted or generalized.
In general, sensitivity is only one part of diagnostic performance. It does not, by itself, provide specificity, predictive values, or the probability that an individual result represents disease. The record lists four outcome measures, but details of the additional outcomes are not reported in the registry record.
The record can therefore be used to understand the study’s purpose, broad design, endpoint and recorded safety counts. It cannot, on the information available, establish a numerical diagnostic accuracy result, its uncertainty, or comparative benefit relative to another screening method.
13. Why This Trial Matters Statistically
Statistically, this study illustrates the distinction between a diagnostic accuracy evaluation and a randomized treatment trial. The registry describes a prospective, single-group study in which participants received ColoSense testing before colonoscopy. Its central question is framed around sensitivity for colorectal cancer, rather than a difference in outcomes between assigned treatment groups.
That distinction guides which quantities are meaningful. For a sensitivity analysis, the key information includes the number of participants who meet the reference definition for colorectal cancer, how many of them have a positive test, and the uncertainty around the resulting estimate. Those values are not reported in the registry record. Without them, the study’s central statistical result cannot be assessed from the record.
The record also highlights why endpoint definitions and analysis populations matter. A count-based endpoint title does not itself specify the denominator, handling of incomplete assessments, test thresholds or reference-standard rules. These details are part of interpreting diagnostic performance, not merely administrative additions. They are not reported in the registry record.
Finally, statistical planning illustrations should be kept separate from observed evidence. Planning assumptions describe hypothetical design choices; they do not replace a reported endpoint estimate and its precision. The study-specific sample-size justification and statistical analysis plan are not reported in the registry record. The statistical importance of the record is therefore chiefly its clear identification of a single-group diagnostic question and the resulting need for transparent endpoint and analysis reporting.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation for interpreting the study from the registry record is that the numerical result for the primary sensitivity endpoint is not reported. The endpoint count, denominator, estimate and confidence interval are not reported in the registry record. As a result, diagnostic performance and its precision cannot be evaluated from the recorded information.
The record says participants underwent colonoscopy after ColoSense testing, but the detailed reference-standard definition and procedures for classifying test results are not reported in the registry record. The timing between test and colonoscopy, handling of inconclusive findings, and procedures for blinded interpretation are also not reported in the registry record. Each can affect the interpretation of a diagnostic accuracy estimate.
Although four outcome measures are listed, the other outcome titles and results are not reported in the registry record. The analysis population, exclusions, missing-data handling, statistical methods and any sensitivity analyses are not reported in the registry record. The protocol, sample-size justification and interim analyses are not reported in the registry record.
The single-group design does not provide a randomized control comparison. The record itself notes that the study is not a randomized comparison and that arms are not a like-for-like control comparison. Thus, the study description should not be read as a comparative trial of different screening strategies. Participant characteristics and eligibility criteria are not reported in the registry record, which also limits assessment of how the evaluated group relates to other populations.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Colorectal Cancer and Pre-Cancerous Adenoma Non-Invasive Detection Test Study — NCT04739722.
- Registry record last updated 2024-10-01; status last verified 2024-09.
- Results first posted 2024-10-01.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT04739722 is a completed, prospective single-group study of ColoSense, a multi-target stool RNA test for colorectal cancer screening. The registry records enrollment of 14263, with ColoSense administered before colonoscopy. The primary endpoint is sensitivity for colorectal cancer, measured as a count of participants within 120 days from stool sample collection.
The record lists zero analyses. A numerical primary endpoint result, its denominator and its uncertainty are not reported in the registry record. The safety entries for Enrolled Subjects record zero serious adverse events, one other adverse event and zero deaths. Details about event definitions and the other adverse event are not reported in the registry record.
The study is not a randomized comparison. Its registry record identifies the diagnostic question and broad study sequence but does not report the analysis details needed to evaluate the numerical sensitivity result.