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 Diagnostic Accuracy of Shear-Wave Elastography for the Preoperative Risk Stratification of Follicular Lesions of the Thyroid (NCT03106337), a na na study. The primary outcome is Shear-Wave Elastography (SWE) Values in kiloPascals (kPa).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03106337 |
| Phase | NA |
| Condition | Thyroid Nodule, Follicular Neoplasm |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 35 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Massachusetts General Hospital |
| Results posted | Yes |
2. Clinical Question
Population
People with a follicular lesion identified on thyroid biopsy and scheduled for thyroid surgery were eligible. The primary outcome population is listed as all enrolled participants; enrollment was 35.
Intervention
Participants underwent a detailed ultrasound examination including shear-wave elastography (SWE) before surgery. SWE produces a quantitative measure of nodule stiffness, reported in kiloPascals (kPa).
Comparator
The comparison was not between randomized treatment groups. SWE measurements were to be compared with the benign or malignant histopathology classification obtained after surgical excision.
Primary question
Do mean SWE measurements differ between thyroid follicular lesions classified as benign and those classified as malignant after surgery, and can SWE help assess malignancy before surgery? The registry describes this as an evaluation of diagnostic accuracy, but does not report diagnostic-accuracy estimates.
The clinical motivation recorded for the study is that a follicular lesion on biopsy may be benign, while the record describes surgery as the means of obtaining a definitive histopathology diagnosis. The study therefore examines whether an ultrasound stiffness measurement might provide information before surgery. Its design does not test a treatment intended to change a health outcome. Rather, it evaluates a diagnostic measurement against the surgical pathology result.
The distinction between the clinical aim and the registered primary outcome is important. The aim concerns identifying malignancy, which is a diagnostic classification question. The primary outcome is specified as mean SWE values in kPa for benign and malignant lesions. Those group measurements could contribute to assessing how well the measurement distinguishes the pathology categories, but the registry record does not report the observed means, their variability, or a measure of diagnostic accuracy. It therefore does not establish how well SWE classified lesions in this study.
3. Trial Design
This was a completed, single-group study sponsored by Massachusetts General Hospital. The registry lists enrollment of 35 and the study dates as 2010-01 to 2012-04. The condition entries are Thyroid Nodule and Follicular Neoplasm. The intervention is the device procedure Shear-Wave Elastography; participants scheduled for partial or total thyroidectomy underwent SWE, and the measurements were compared with pathology from surgical excision.
The record lists phase as NA, allocation as NA, and masking as none. The single-group model reflects the diagnostic-measurement design: there is no randomized intervention arm and no like-for-like control arm. The intended contrast is between lesions classified as benign and malignant by post-surgical histopathology, not between groups assigned to different treatments or diagnostic procedures. The pathology result supplies the reference classification against which the ultrasound measurement is considered.
The primary outcome is a continuous measure: mean SWE values in kPa. The registry describes measurements in three planes—traverse, sagittal, and transverse with the nodule in the center—and specifies Baseline (Day 0) as the timeframe. The record says values for benign lesions were compared with values for malignant lesions identified by histopathology after surgery.
The registry record does not report a sample-size justification, a detailed statistical analysis plan, or additional registered analyses. It also does not report how participant eligibility was operationalized beyond the biopsy diagnosis and planned surgery described in the study summary. The listed enrollment is the study enrollment, not an indication of how many lesions were ultimately represented in each histopathology category or how many participants had analyzable measurements. Those counts are not reported in the registry record.
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 | Shear-Wave Elastography |
|---|---|
| STARTED | 35 |
| COMPLETED | 35 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: All enrolled participants.
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: All enrolled participants.
| Characteristic | Unit | Shear-Wave Elastography |
|---|---|---|
| Participants analysed | 35 | |
| Age, Continuous | years | 55 (SD 16.1) |
| Sex: Female, Male: Female | Participants | 23 |
| Sex: Female, Male: Male | Participants | 12 |
| Region of Enrollment: United States | participants | 35 |
6. Primary Endpoint
The registry lists the primary outcome as Shear-Wave Elastography (SWE) Values in kiloPascals (kPa), measured over Baseline (Day 0).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | kPa |
| Endpoint classification | Continuous Endpoint |
The primary outcome is mean shear-wave elastography (SWE) value, measured in kiloPascals (kPa), at Baseline (Day 0). SWE is described as providing a quantitative score of thyroid nodule stiffness. The record states that measurements were taken in three planes: traverse, sagittal, and transverse, with the nodule in the center. The intended comparison is between mean values for lesions classified as benign and lesions classified as malignant by histopathology after surgery.
This endpoint is relevant to the stated diagnostic question because the study aims to assess whether a preoperative stiffness measurement carries information about the lesion's later pathology classification. A continuous measurement can be compared across pathology groups to examine whether their observed distributions differ. Such a comparison is not, by itself, a complete account of diagnostic accuracy: classification performance also depends on how a measurement is translated into a positive or negative test result and on how those results correspond to the reference diagnosis.
The registry record does not report the mean SWE values, standard deviations, group sizes, a threshold for classifying lesions, or diagnostic-accuracy estimates. It also does not state whether a separate summary for each plane or a combined measurement was used for any diagnostic classification. Consequently, the endpoint definition can be described, but its observed result and its precision cannot be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record sets out a diagnostic study question but does not post the numerical primary outcome results. Although it specifies mean SWE values in kPa and says benign and malignant lesions were compared using post-surgical histopathology, it does not report either group's mean or standard deviation. It also does not provide the number of benign and malignant lesions contributing to the comparison. The magnitude, direction, and precision of any difference therefore cannot be evaluated from the registry record.
The study summary describes diagnostic accuracy as the main goal. However, no sensitivity, specificity, predictive values, area under a curve, classification threshold, or other diagnostic-accuracy result is reported in the registry record. A difference in average stiffness between pathology categories, if observed, would not alone show how accurately SWE classifies individual lesions. Group averages can differ while individual measurements overlap. To assess classification, a threshold or other rule and its performance against the reference diagnosis would need to be reported.
The study enrolled 35 participants, but enrollment alone does not establish the effective sample size for the primary comparison. The record does not state how many participants had benign or malignant histopathology, whether every enrolled participant had usable SWE measurements, or whether any were excluded from the analysis. Without those details, the amount of information contributing to the comparison is unclear.
The registry lists no registered analysis entries. That absence does not establish which analyses were or were not performed; it means the registry record does not provide those analysis details. The record also does not report a prespecified statistical model, adjustment variables, handling of multiple measurement planes, or an approach to missing values. Interpretations should therefore be limited to the stated outcome definition and study aim, rather than assuming a specific analysis strategy.
The study is single-group and is not a randomized comparison of treatment strategies. Its central comparison is between diagnostic measurement values and pathology categories, so causal claims about treatment effects are not applicable. Even a reported association between stiffness and pathology would need to be interpreted as diagnostic evidence from the studied participants, with attention to the small enrollment and any uncertainty in the estimates. No such numerical estimates are available in the registry record.
Planning illustrations based on an observed effect, if considered, should not be read as evidence that the study had a particular probability of detecting an effect. They are planning calculations, not observed power. The registry record does not provide the observed effect value or the resulting planning counts in the registry record for this analysis. More importantly, the actual diagnostic findings remain unreported in the registry record.
9. Statistical Methods Explained
The registered primary outcome is a continuous measurement, not a binary diagnosis. SWE values are expressed in kPa and described as quantitative scores of nodule stiffness. The study's diagnostic aim requires considering those measurements in relation to the pathology categories established after surgery. The registry record specifies that comparison but does not report the numerical results or the statistical procedure used to make it.
What does a mean describe?
In general, a mean is a measure of the central location of a set of observations. Comparing means across groups can summarize whether their average measurements differ. In this study, the intended groups are lesions categorized as benign and malignant by histopathology. A mean difference would describe a group-level contrast; it would not tell how much the individual measurements overlap, nor whether a particular lesion can be classified correctly.
The registry lists standard deviation as the measure of dispersion for the primary outcome. In general, standard deviation describes how spread out observations are around their mean. It is not the same as uncertainty in the estimated mean. The standard deviation and sample size together inform the precision of a mean estimate, while a confidence interval is commonly used to express uncertainty around an estimate. The registry record does not report standard deviations, confidence intervals, or the number of observations in either pathology group, so the precision of the group estimates cannot be judged.
How does the pathology comparison relate to diagnostic accuracy?
Histopathology after surgery is the reference classification described in the record. The diagnostic question is whether a preoperative SWE measurement helps distinguish lesions that are later classified as benign from those classified as malignant. General diagnostic evaluation separates measurement association from classification performance. A group comparison assesses how measurements behave across reference categories. Classification measures assess how a specified test rule labels individual cases relative to the reference diagnosis. The registry record does not report a test threshold or diagnostic-accuracy statistics, so the latter cannot be interpreted.
The three measurement planes named in the outcome description raise a general analysis consideration: repeated measurements from one lesion may be related to one another. A statistical analysis would need to make clear whether the planes were analyzed separately, combined, or handled through another summary. The registry record does not report which approach was used. It would not be appropriate to assume that three plane-specific measurements are independent observations or that they were combined into one value.
What does variation among measurements imply?
In general, greater spread within a pathology group can make its mean less precisely estimated and can also make the groups' measurements overlap more. This matters for diagnostic use because separation of group averages does not guarantee reliable classification of individual lesions. The clinical interpretation depends not only on estimated central values, but also on variability and on the chosen classification rule. The registry record contains no numerical spread or overlap information.
General statistical methods for continuous outcomes may include comparisons of means, estimates of mean differences, confidence intervals, or regression models. The appropriate method depends on the data structure, assumptions, and analysis plan. The registry record does not report which method was used, whether assumptions were checked, or whether any covariates were included. No particular method or result should be inferred from the fact that the outcome is continuous.
What do the planning assumptions mean?
The registry's planning assumptions describe an illustration based on the observed effect, rather than the study's own design justification. The illustration uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is stated as a fraction of the observed effect. For time-to-event calculations, the stated convention is total events; for other calculations, it is participants per arm. These are planning conventions, not outcomes observed in the study and not evidence of observed power.
Those hypothetical assumptions do not match the registered single-group diagnostic design as a randomized two-arm comparison. The fact that a planning illustration uses equal allocation between arms should not be taken to mean that this study assigned participants to two arms. The registry record does not report its own sample-size rationale, and the illustrative inputs cannot replace a prespecified design justification. No planning count or observed effect value is available in the registry record for interpretation.
What is not available for evaluating the analysis?
The record reports zero registered analysis entries. It does not provide an analysis population definition, missing-data procedures, subgroup plans, multiplicity adjustments, or a model specification. These omissions leave important aspects of the analysis and reporting unclear. General explanations of means, dispersion, confidence intervals, and diagnostic classification describe statistical concepts; they do not fill in the unreported analysis methods or results for this study.
10. Multiplicity, Missing Data and Analysis Populations
The registry record describes measurements in three planes and a primary outcome comparing mean SWE values for benign and malignant lesions. It does not report whether the planes were treated as separate analyses, combined into a summary, or used in another way. It also does not identify additional primary or secondary outcome measures in the information available for this analysis. Without those details, the number of statistical comparisons and any approach to multiplicity are not reported in the registry record.
In general, conducting multiple statistical tests can increase the chance of finding an apparently notable result by chance. Methods to address multiplicity may include prespecifying one primary comparison, adjusting inferential thresholds, or treating additional analyses as exploratory. The registry record does not state whether any such approach was planned or used; no multiplicity adjustment should be assumed.
The record lists 35 enrolled participants but does not report analysis counts by pathology category, the number with complete SWE measurements, or the number included in the primary comparison. Missing-data methods and reasons for any missing measurements are not reported in the registry record. It is therefore not possible to determine whether all enrolled participants contributed to the endpoint analysis or whether missingness could have affected the comparison.
The primary outcome population is listed as all enrolled participants, but that label does not give the operational definition of the analyzed population. The registry record does not specify whether the analysis required both SWE measurements and surgical histopathology, or how cases lacking either would be handled. These details matter because a diagnostic comparison depends on paired measurement and reference information. The record also does not report exclusions or analysis populations defined for particular planes or pathology categories.
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 |
|---|---|---|---|
| Shear-Wave Elastography | 0 | 35 | 0.0% |
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 |
|---|---|
| Shear-Wave Elastography | 0 of 35 |
The registry lists 35 participants at risk for serious adverse events in the Shear-Wave Elastography group and records 0 affected. For other adverse events, it likewise lists 35 at risk and 0 affected. These figures describe what is recorded in the adverse-event fields; they are not measures of the primary diagnostic outcome.
The deaths field is null, and the registry record does not report a death count. The serious adverse-event terms list is empty. An entry of 0 affected means no affected participants are recorded in that category in the posted results; it should not be expanded into a claim about every possible symptom or event unless the record reports those details.
Safety counts need their denominators to be read in context. Here, the listed at-risk group is 35 for both serious and other adverse events. The registry does not provide event descriptions, severity breakdowns beyond the serious-event category, timing, or additional detail about collection and attribution. These figures therefore support only a narrow description of the posted adverse-event counts, not a broader conclusion about safety.
12. What the Result Does, and Does Not, Mean
The registry record documents a completed study of SWE in people with thyroid follicular lesions scheduled for surgery, with post-surgical histopathology as the reference classification. Its stated aim was to evaluate whether SWE could help diagnose malignancy before surgery. The registered primary outcome focuses on mean stiffness values for benign and malignant lesions. These details define the question, but do not establish the result.
The primary outcome values are not reported in the registry record. Neither group means nor standard deviations are available, and no diagnostic-accuracy estimates or classification threshold are reported. Consequently, the record does not show the direction or size of any group difference, how precisely an effect was estimated, or how well SWE classified lesions. It cannot be used to conclude that the measurement did or did not distinguish the pathology groups.
Even when diagnostic measurements differ on average between categories, that finding alone does not determine how accurately a test classifies individual cases. General interpretation would also consider the distribution of values, the decision threshold, and performance relative to the reference diagnosis. Those elements are not reported. The registry enrollment of 35 does not reveal how many participants fell into each pathology category or contributed complete data.
This was not a randomized comparison of alternative diagnostic strategies or treatment groups. It was a single-group study in which a preoperative measurement was compared with pathology obtained after surgery. The design can address an association between SWE values and pathology classification if results are reported, but the registry record does not present those results. Nor does it report whether the findings were validated in another group.
The appropriate conclusion is therefore limited: the record describes a diagnostic study and its intended endpoint, but does not provide the numerical findings needed to evaluate diagnostic performance. The absence of results in the registry record is not evidence that SWE was ineffective or that it was accurate. It means the posted record does not permit either conclusion.
13. Why This Trial Matters Statistically
This study illustrates a key distinction in diagnostic research: measuring a biological feature is not the same as demonstrating that a test can classify patients accurately. SWE supplies a quantitative stiffness value, while the clinical question concerns whether that value can distinguish lesions later categorized by histopathology. Statistical reporting needs to connect those steps clearly.
A comparison of mean values can describe a difference between pathology groups, but diagnostic interpretation requires more than an average. Individual measurements may vary within each group, and group distributions may overlap. The value of a measurement for classification depends on how the test is interpreted and how its results correspond to the reference diagnosis. This distinction is especially relevant when an outcome is continuous but the clinical decision concerns categories such as benign and malignant.
The registry also identifies measurements in three planes. Reporting how multiple measurements from the same lesion are handled is statistically important because they may be related. Separate plane-specific comparisons, a combined summary, and a model that accounts for repeated measurements answer different questions. The registry record does not state which approach was used, emphasizing why a transparent analysis description is needed to interpret diagnostic results.
Finally, enrollment alone does not describe the precision of the pathology comparison. The distribution of participants across reference categories and the number with complete measurement and pathology data would affect the information available. Those counts and the primary numerical results are not reported in the registry record. The study is therefore a useful example of why outcome definitions, analysis populations, uncertainty estimates, and diagnostic-performance measures all matter alongside a stated clinical aim.
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 principal limitation for interpreting this record is that the primary outcome results are not reported. The means and standard deviations for benign and malignant lesions, group counts, confidence intervals, and diagnostic-accuracy estimates are absent. As a result, the magnitude, direction, and precision of the intended comparison cannot be assessed.
The registry describes 35 enrolled participants but does not report how many had benign or malignant pathology, how many had complete measurements, or whether any were excluded from analysis. This prevents assessment of the effective sample size and the balance between pathology categories. The record also does not report how measurements from the three named planes were combined or analyzed.
Statistical analysis details are limited. The registry has no registered analysis entries, and the record does not state the model, covariate adjustments, missing-data approach, multiplicity strategy, or diagnostic threshold. It does not report a sample-size justification. These omissions limit reproducibility and make it difficult to determine how the planned diagnostic question was translated into an analysis.
The study is single-group and uses surgical histopathology as the reference classification. It is not a randomized comparison of diagnostic strategies, and the registry record does not describe validation in a separate participant group. These design features should be considered when interpreting any diagnostic findings if they are reported elsewhere; they do not substitute for the missing results in this record.
Finally, the stated primary measure is a comparison of continuous SWE values, while the study aim concerns diagnostic accuracy. Without reported classification rules and performance estimates, the relationship between the registered endpoint and the clinical diagnostic aim remains unclear.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Diagnostic Accuracy of Shear-Wave Elastography for the Preoperative Risk Stratification of Follicular Lesions of the Thyroid — NCT03106337.
- Registry record last updated 2017-05-16; status last verified 2017-04.
- Results first posted 2017-05-16.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT03106337 is a completed, single-group diagnostic study sponsored by Massachusetts General Hospital, with enrollment of 35. The study dates are recorded as 2010-01 to 2012-04. Participants with a follicular lesion on thyroid biopsy who were scheduled for surgery underwent preoperative shear-wave elastography.
The primary outcome is mean SWE value in kPa at Baseline (Day 0), with measurements described in three planes. The intended comparison is between benign and malignant lesions classified by post-surgical histopathology. The registry lists no registered analysis entries and does not report primary outcome values or diagnostic-accuracy results. Its adverse-event fields record 0 affected among 35 at risk for both serious and other adverse events; the deaths field is not reported.