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 Helical CT, PET/CT, MRI, and CBCT Alone or in Combination in Predicting Jaw Invasion in Patients With Oral Cancer (NCT03053960), a registered phase not stated study. The primary outcome is Accurate Predication of the Presence or Absence of Bone Invasion by Oral Squamous Cell Carcinoma by Helical CT, PET/CT, MRI and CBCT.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03053960 |
| Phase | Phase not stated |
| Condition | Oral Cavity Squamous Cell Carcinoma |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 8 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University |
| Results posted | Yes |
2. Clinical Question
Population
Patients with oral cavity squamous cell carcinoma were the population of interest. The record lists enrollment as 8, but its primary-outcome description says that no study data are available. It therefore does not provide participant-level characteristics or an analyzable population for assessing diagnostic performance.
Intervention
The diagnostic approach involved helical CT, PET/CT, MRI, and CBCT, with the stated aim of assessing whether oral cancer had invaded the jaw bone. The record also describes conventional surgical resection and histopathologic examination.
Comparator
For the diagnostic question, imaging findings were to be compared with histologic examination of surgical specimens. This is a reference-standard comparison, not a randomized treatment comparison. The record does not report a separate control group or a like-for-like comparison between treatment arms.
Primary question
How accurately can clinical examination and imaging modalities identify the presence or absence of bone invasion by oral squamous cell carcinoma, when histopathology is used as the reference? The planned measures include sensitivity, specificity, and positive and negative predictive values. Those measures are not available in the registry record because it reports no study data.
3. Trial Design
This was a diagnostic-imaging study in patients with oral cancer, rather than a randomized comparison of treatments. The listed diagnostic group was to undergo helical CT, PET/CT, MRI, and CBCT scans, as well as conventional surgical resection of the tumor. Histopathologic examination of specimens was the reference for determining whether bone invasion was present. The record does not describe a separate control arm or a randomized allocation process.
The stated objective was to assess whether the imaging modalities, individually or in combination, could predict invasion of the maxilla or mandible. The primary outcome description also includes clinical examination and any other imaging modality used. It specifies planned calculations of sensitivity, specificity, and positive and negative predictive values against histologic examination.
The registry lists enrollment as 8 and gives a primary-outcome timeframe of up to 2 years. It lists the study as terminated and states that it was terminated by the IRB. The primary-outcome description says that efforts were made to gather and report the data, but no data are available for the study. Thus, the design and intended diagnostic question can be described, but diagnostic accuracy cannot be evaluated from the registry record.
The record does not report a statistical analysis plan, sample-size justification, interim analyses, or a detailed account of how imaging readings were obtained or compared. It also does not report enough information to assess whether imaging interpretation and histopathologic assessment were conducted independently. These omissions limit evaluation of the planned study methods, apart from the central fact that outcome data are unavailable.
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.
Overall Study
| Stage | Diagnostic (Helical CT, PET/CT, MRI, CBCT) |
|---|---|
| STARTED | 8 |
| COMPLETED | 8 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: The study was terminated by the IRB. Sincere efforts were made to gather and report the data, however, no data is available for the study.
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.
| Characteristic | Unit | Diagnostic (Helical CT, PET/CT, MRI, CBCT) |
|---|---|---|
| Participants analysed | 8 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 5 |
| Age, Categorical: >=65 years | Participants | 3 |
| Sex: Female, Male: Female | Participants | 3 |
| Sex: Female, Male: Male | Participants | 5 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 8 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 7 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 8 |
6. Primary Endpoint
The registry lists the primary outcome as Accurate Predication of the Presence or Absence of Bone Invasion by Oral Squamous Cell Carcinoma by Helical CT, PET/CT, MRI and CBCT, measured over Up to 2 years.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint concerns the ability of clinical examination and imaging to identify the presence or absence of bone invasion by oral squamous cell carcinoma. The record names CBCT, helical CT, PET/CT, MRI, and any other imaging modality used, and specifies histologic examination of specimens as the reference. It describes sensitivity, specificity, and positive and negative predictive values as the intended measures.
In general, sensitivity describes how often a test identifies invasion when the reference assessment finds invasion. Specificity describes how often a test identifies absence of invasion when the reference assessment finds no invasion. Positive and negative predictive values describe how often a positive or negative test result, respectively, agrees with the reference assessment. Predictive values depend on the mix of cases assessed, so they are not interchangeable with sensitivity and specificity.
These measures are useful for describing diagnostic classification because they address different kinds of agreement and error relative to a reference assessment. They do not, by themselves, show how imaging results affect surgical decisions or patient outcomes. In this record, the planned measures are described, but their values are not reported. The stated reason is that no study data are available.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record establishes a diagnostic question and a planned reference-standard approach, but it does not provide evidence from which diagnostic accuracy can be estimated. The primary outcome description explicitly says that no data are available. Consequently, sensitivity, specificity, positive predictive value, and negative predictive value cannot be read as observed findings for this study. Nor can the record support a comparison of the performance of the named modalities or their combinations.
The intended reference was histologic examination of surgical specimens. In general, diagnostic-accuracy estimates depend on the classification of each assessment relative to that reference: whether imaging and histology both indicate invasion, both indicate no invasion, or disagree. Those classifications are needed to calculate the planned measures. They are not reported in the registry record, so there is no basis for judging the direction or frequency of agreement or disagreement.
The enrollment field lists 8, but that figure does not substitute for the missing diagnostic outcomes. It cannot establish how many assessments were interpretable, how many specimens were available for comparison, or how many cases had bone invasion. Those details are not reported in the registry record. No counts of true-positive, false-positive, true-negative, or false-negative assessments are available.
The study status is terminated, and the primary-outcome description attributes termination to the IRB. The record does not explain the circumstances or give a reason beyond that statement. It says that efforts were made to gather and report data, while also stating that no data are available. This should be read as an absence of reportable outcome information, not as a diagnostic result showing that the imaging methods were accurate or inaccurate.
The secondary outcome listed is incidence of sparing resection, but its results are not reported in the registry record. The record lists two outcome measures and no analyses. It does not provide numerical estimates, uncertainty intervals, or a statistical comparison. Without such information, precision and statistical uncertainty cannot be assessed.
Any planning illustration based on an observed effect should be distinguished from an observed trial result. The registry record provides no primary outcome data from which an observed diagnostic effect can be verified. Planning calculations are not evidence of diagnostic performance, and they are not observed power. The study therefore contributes a stated research question and design description, but no reported quantitative answer to that question.
9. Statistical Methods Explained
The planned analysis is a diagnostic-accuracy assessment. It asks how often clinical examination and imaging classifications agree with histologic examination of surgical specimens regarding bone invasion. The registry names helical CT, PET/CT, MRI, CBCT, and any other imaging modality used. Histology is the stated reference for this comparison.
What do sensitivity and specificity describe?
In general, sensitivity describes the proportion of reference-positive cases that a test classifies as positive. Specificity describes the proportion of reference-negative cases that a test classifies as negative. These are conditional measures: sensitivity is evaluated among cases the reference identifies as having the condition, while specificity is evaluated among cases the reference identifies as not having it. They address different patterns of classification error and should not be treated as interchangeable.
To estimate either measure, the data must identify each test result and its corresponding reference result. A classification of test-positive and reference-positive contributes to the sensitivity calculation; a test-negative and reference-negative classification contributes to specificity. Disagreements are also essential because they determine how often the test misses reference-positive cases or incorrectly labels reference-negative cases. The registry does not report these paired classifications.
What do predictive values add?
In general, positive predictive value is the proportion of positive test results that are also positive by the reference assessment. Negative predictive value is the proportion of negative test results that are also negative by the reference assessment. These measures describe the reference status among people with a particular test result. Unlike sensitivity and specificity, predictive values can change with the prevalence of the condition in the population being assessed. Their interpretation therefore depends on the cases included, as well as the test and reference classifications.
The registry says these values were to be calculated for each modality using positive and negative classifications, including false-positive and false-negative results. It does not report the underlying classifications or estimates. No precision intervals are reported either. As a result, neither the performance estimates nor their uncertainty can be assessed.
Why use histology as the reference?
In general, diagnostic studies need a reference assessment against which a test can be evaluated. Here, the record identifies histologic examination of specimens as that reference. This makes the planned question one of agreement with the tissue assessment, rather than a comparison of imaging with another imaging method alone. The record does not describe the procedures for reading or adjudicating imaging and histology, so details about blinding or independent assessment are not reported in the registry record.
How should modality comparisons be interpreted?
Comparing diagnostic methods requires performance estimates for each method using a clearly defined set of cases and the same reference approach. Assessing combinations of modalities also requires a defined rule for combining their results. The record says that modalities alone or in combination were of interest, but it does not report combination rules or results. Without those details, it is not possible to tell whether combinations were evaluated under a prespecified procedure or to compare their performance.
Diagnostic estimates can also be affected by which participants receive each test and by whether test results are available when the reference assessment is interpreted. In general, differences in who is assessed or how assessments are conducted can make apparent accuracy difficult to compare. The registry does not report these operational details. This is a limitation in evaluating the intended methods, separate from the absence of outcome data.
What is the role of planning calculations?
The record describes planning assumptions that include a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a fraction of an observed effect. It also characterizes the calculations as planning illustrations rather than the trial's own design. The listed diagnostic group and the absence of reported outcome data mean that the record does not provide a verifiable observed diagnostic effect for interpreting such illustrations. They should not be read as results, as evidence of precision, or as observed power.
In general, a confidence interval conveys the range of effect values compatible with the data and the statistical procedure used. A wider interval indicates less precision than a narrower interval, while an interval's interpretation depends on the method and assumptions. No confidence intervals or other uncertainty estimates for diagnostic performance are reported in this registry record. Given the lack of outcome data, no interval can be used to assess how precisely the planned endpoint was estimated.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome description names several diagnostic assessments: clinical examination, CBCT, helical CT, PET/CT, MRI, and any other imaging modality used. It also raises the possibility of assessing modalities in combination. This creates multiple potential diagnostic estimates, but the registry record does not report how those assessments were prioritized or whether a multiplicity procedure was planned. A statistical plan describing primary comparisons, adjustment for multiple testing, or selection among combinations is not reported in the registry record.
In general, examining many outcomes or comparisons can increase the chance of finding an apparently notable result by chance if each is interpreted independently. Prespecifying the main question and analysis approach helps readers understand how such results should be interpreted. Here, there are no reported diagnostic estimates to evaluate, and the record does not provide the analysis details needed to determine how multiplicity would have been handled.
The primary-outcome description states that no study data are available. The record does not report participant-level missingness, missing imaging assessments, unavailable specimens, or exclusions from an analysis population. It therefore cannot show whether any missingness occurred or how it might affect the intended estimates. Analysis populations, including any definition of which cases would be included in each modality-specific calculation, are not reported in the registry record.
The study is listed as terminated by the IRB, but the record does not give further detail about the decision or explain its implications for data collection. No interim analyses or formal statistical analysis plan are reported. These omissions prevent assessment of planned handling of multiple comparisons, missing data, and analysis populations.
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 |
|---|---|---|---|
| Diagnostic (Helical CT, PET/CT, MRI, CBCT) | 0 | 8 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Diagnostic (Helical CT, PET/CT, MRI, CBCT) | 0 of 8 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Diagnostic (Helical CT, PET/CT, MRI, CBCT) | 0 of 8 |
The registry lists one diagnostic group for adverse-event reporting. For that group, the record lists 8 at risk for serious adverse events and 0 affected. It also lists 8 at risk for other adverse events and 0 affected, with 0 deaths. These are the registry's recorded safety counts; they do not provide detailed event descriptions or participant-level follow-up information.
In general, an observed count of zero is not proof that an event cannot occur. It describes what was recorded in the group and follow-up represented in the registry, not the certainty of risk in other settings. The record does not report the duration or completeness of safety follow-up, nor does it provide further detail on how adverse events were collected. Its overall statement that no study data are available also means the safety figures should not be mistaken for a complete clinical outcome report.
The listed counts should be interpreted as descriptive registry entries, not as evidence comparing safety between treatments. The record does not describe a like-for-like control group or a randomized treatment comparison. It also does not provide an analysis of adverse events by imaging modality. These figures therefore cannot support comparative safety conclusions about the diagnostic methods.
12. What the Result Does, and Does Not, Mean
The record identifies an important diagnostic question: whether imaging can predict bone invasion in oral cancer when histologic examination is used as the reference. It names helical CT, PET/CT, MRI, and CBCT and describes intended calculations of sensitivity, specificity, and predictive values. These details clarify what the study set out to assess.
However, the registry states that no data are available for the study. It reports no diagnostic classifications, accuracy estimates, uncertainty intervals, or results for the listed secondary outcome. It therefore does not establish whether any modality or combination correctly identified bone invasion, nor does it show that any method performed better or worse than another.
The record also does not answer whether imaging altered surgical planning or whether any approach improved patient outcomes. The stated rationale links accurate prediction with surgical planning, but rationale is not evidence of an observed effect. No conclusion about treatment benefit, clinical utility, or patient outcomes can be drawn from the available registry information.
Likewise, the enrollment figure does not resolve the absence of outcome data. It does not tell readers how many usable paired imaging and histology assessments were available, or how cases were distributed by invasion status. Those details are not reported in the registry record. Without paired classifications, the planned diagnostic measures cannot be calculated or interpreted.
The appropriate reading is therefore narrow: the registry documents a terminated study with a specified diagnostic objective and no reported study data. It does not establish that the imaging methods succeed or fail. Further evidence would be needed to estimate their diagnostic performance and assess the precision and generalizability of those estimates.
13. Why This Trial Matters Statistically
This study matters statistically because diagnostic accuracy depends on paired information: the result of an index test and the result of a reference assessment for the same case. The record identifies histopathology as the reference and names several imaging methods. That structure makes clear what data would be needed to answer the diagnostic question, even though the registry reports none of those data.
The planned measures address distinct aspects of classification. Sensitivity and specificity condition on the reference assessment, while positive and negative predictive values condition on the test result. In general, those distinctions matter because a test may perform differently across these measures, and predictive values also depend on the population being assessed. Reporting the measures separately can give a fuller account than a single overall accuracy figure.
The record also illustrates why a stated analysis objective is not the same as an empirical result. The endpoint description specifies intended calculations, but those calculations require observed classifications and their reference outcomes. Since the registry says no study data are available, there is no basis for estimating the listed measures or their precision. A design description alone cannot reveal whether the intended comparisons were informative.
Finally, the terminated status and lack of reported data limit what can be learned from this record. Planning assumptions, where shown, should not be confused with observed diagnostic performance or observed power. The statistical value of a diagnostic study depends on the availability and quality of the paired data, transparent analysis methods, and interpretable estimates with uncertainty. Those elements are not reported.
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 central limitation is that the registry states that no study data are available. This prevents evaluation of the primary diagnostic endpoint and the listed secondary outcome. There are no reported sensitivity, specificity, predictive-value estimates, confidence intervals, or modality-specific results.
The registry lists enrollment as 8, but does not report participant characteristics, the distribution of bone invasion, or how many cases had usable results for each imaging method and histologic examination. It also does not report the numbers of positive and negative classifications or disagreements between imaging and the reference assessment. These omissions prevent assessment of the diagnostic data structure and the precision of any estimate.
The record describes several modalities and the possibility of their use in combination, but does not state how combined results were defined or how modality comparisons were prioritized. A statistical analysis plan, sample-size justification, interim analyses, and a multiplicity strategy are not reported in the registry record. Details about image interpretation, histology assessment, blinding, and handling of unavailable assessments are also not reported.
The study is listed as terminated by the IRB, but the registry does not provide further explanation. The listed safety counts are descriptive and do not resolve the absence of primary outcome data or provide comparative safety evidence. Overall, the record documents the intended question and some design features, while leaving the diagnostic findings and important analysis details unavailable.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Helical CT, PET/CT, MRI, and CBCT Alone or in Combination in Predicting Jaw Invasion in Patients With Oral Cancer — NCT03053960.
- Registry record last updated 2025-04-30; status last verified 2025-04.
- Results first posted 2019-12-18.
- 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
This registry record describes a diagnostic-imaging study in oral cavity squamous cell carcinoma. It was intended to assess whether helical CT, PET/CT, MRI, CBCT, clinical examination, and other imaging could predict jaw-bone invasion, using histologic examination of specimens as the reference. The primary outcome description names sensitivity, specificity, and positive and negative predictive values.
The record lists enrollment as 8, gives a primary-outcome timeframe of up to 2 years, and marks the study as terminated by the IRB. It states that no study data are available. Consequently, the registry does not report diagnostic accuracy results or results for the listed secondary outcome, incidence of sparing resection. The recorded safety entries list 0 serious adverse events, 0 other adverse events, and 0 deaths in the diagnostic group, with 8 at risk for each adverse-event category. The record does not support conclusions about comparative performance or clinical benefit.