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 Evaluation of Blood/Imaging Based Biomarkers, Aromatase Inhibitor Induced Musculoskeletal Syndrome (NCT03665077), a na na study. The primary outcome is Oxylipin Levels.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03665077 |
| Phase | NA |
| Condition | Aromatase Inhibitor Induced Musculoskeletal Syndrome (AIMSS), Breast Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 28 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Arizona |
| Results posted | Yes |
2. Clinical Question
Population
Patients with breast cancer who have completed their primary treatments, described as surgery with or without radiation therapy, and are scheduled to start adjuvant hormonal therapy. The registry lists an enrollment of 28. Further eligibility details are not reported in the registry record.
Intervention
This is a biomarker-assessment study rather than a comparison of therapeutic interventions. Assessments include an initial blood draw and SWE ultrasound, blood draws at three months and six months, and SWE ultrasound at six months. The record describes the study as a pilot evaluating blood- and imaging-based biomarkers.
Comparator
There is no separate control group. The design is listed as single group, and allocation is listed as NA. The measurements are planned at different times for the study participants; these time points are not randomized treatment arms or a like-for-like control comparison.
Primary question
The primary outcome is oxylipin levels, measured in pg/mL, at baseline, three months, and six months. The stated aim is to assess change across those time points in the context of aromatase inhibitor induced musculoskeletal syndrome. Numerical results for the primary outcome are not reported in the registry record, so the size and precision of any observed change cannot be described.
3. Trial Design
The registry describes a completed pilot trial with a single-group design. It lists enrollment of 28 and identifies the sponsor as the University of Arizona. The phase is listed as NA, allocation as NA, and masking as none. There is no randomized treatment assignment or separate comparison group described. Accordingly, the study is structured around biomarker measurements over time rather than a comparison between assigned treatments.
The population is described as patients with breast cancer who completed primary treatment, surgery with or without radiation therapy, and are scheduled to start adjuvant hormonal therapy. The assessments include an initial blood draw and initial SWE ultrasound, further blood draws at three months and six months, and SWE ultrasound at six months. The primary outcome timeframe is baseline, three months, and six months. The registry also lists tendon stiffness and pain levels as secondary outcomes.
The recorded study dates are a start date of 2018-02-28 and a primary completion date of 2022-06-15. The status is completed. The registry does not report the actual timing of each participant’s assessments, departures from the planned schedule, or whether every enrolled participant contributed measurements at every time point. Those details matter when interpreting repeated assessments, because the number and pattern of available measurements can affect the analysis.
Although the study concerns symptoms associated with aromatase inhibitor therapy, the listed interventions are diagnostic tests and assessments, not assigned treatment regimens. No protocol details about hormonal therapy, its duration, or variation in treatment are reported in the registry record. The design therefore supports describing biomarker measurements over time in this study group, but it does not establish a treatment effect by comparison with a control group.
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: This is a single arm observational study
Overall Study
| Stage | Participants |
|---|---|
| STARTED | 28 |
| 3 Months Blood Draw | 22 |
| 6 Months Blood Draw | 24 |
| COMPLETED | 24 |
| NOT COMPLETED | 4 |
Reasons for not completing this period:
| Reason | Participants |
|---|---|
| Lost to Follow-up | 2 |
| Physician Decision | 2 |
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 | Participants |
|---|---|---|
| Participants analysed | 28 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 13 |
| Age, Categorical: >=65 years | Participants | 15 |
| Age, Continuous | Years | 66.0 (63.1 to 72.6) |
| Sex: Female, Male: Female | Participants | 28 |
| Sex: Female, Male: Male | Participants | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 3 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 25 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| 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 | 25 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 3 |
| Region of Enrollment: United States | participants | 28 |
| Stage of Cancer: Stage 0 | Participants | 8 |
| Stage of Cancer: Stage 1 | Participants | 17 |
| Stage of Cancer: Stage 2 | Participants | 3 |
6. Primary Endpoint
The registry lists the primary outcome as Oxylipin Levels, measured over Baseline, Three months, and Six months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | pg/mL |
| Endpoint classification | Continuous Endpoint |
The primary outcome is oxylipin levels, measured in pg/mL, with assessments scheduled at baseline, three months, and six months. The registry describes the outcome as change in oxylipin levels across those time points and specifies the mean as the summary measure, with standard deviation as the measure of dispersion. Oxylipins are being evaluated as blood-based biomarkers in a pilot study focused on aromatase inhibitor induced musculoskeletal syndrome.
Repeated measurements can describe how a marker varies over time within the study group. A mean gives a summary of the measured levels, while a standard deviation describes how spread out individual measurements are around that mean. These summaries can help characterize the distribution and potential time pattern of a biomarker; they do not, by themselves, establish why a change occurred or whether it corresponds to a clinically important difference.
The registry does not report numerical oxylipin means, standard deviations, changes, or confidence intervals. It also does not report a threshold for interpreting a change as meaningful. Therefore, the endpoint’s planned measurement and summary are clear, but its observed magnitude and precision cannot be evaluated from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
This is a descriptive biomarker study with measurements planned at baseline, three months, and six months. Its single-group structure means there is no separate control group against which to compare the observed time pattern. If measurements changed over time, that pattern could be described for the participants with available data, but the design alone could not distinguish changes related to hormonal therapy from changes related to time, other care, participant characteristics, or measurement variability.
The registry identifies oxylipin levels as the primary outcome and tendon stiffness and pain levels as secondary outcomes. It does not report numerical outcome results for these measures. In particular, no means, standard deviations, estimated changes, uncertainty intervals, or statistical test results are included in the record. Thus, the direction, size, and precision of any observed biomarker or symptom pattern are not reported in the registry record. No conclusion about the presence or absence of a change can be drawn from the outcome descriptions alone.
For a continuous outcome, a mean summarizes the central level in the observed data, and a standard deviation describes variability among observations. Neither quantity is an estimate of the uncertainty in the mean by itself. A confidence interval, if reported, would express the range of values compatible with the data and the stated analysis under its assumptions. No confidence interval is reported for the primary outcome in the registry record, so the precision of an estimated change cannot be assessed.
The repeated assessments can be informative for describing how measurements develop over time, but their interpretation depends on which observations were available and how they were analyzed. The registry does not report whether the analysis used all available measurements, required complete records, adjusted for baseline values, or accounted for correlation among repeated measurements. These choices can affect both the estimate and its uncertainty. The analytic method and analysis population are not reported in the registry record.
The record lists 28 participants as enrolled. That figure describes enrollment, not necessarily the number contributing to each outcome or each time point. The number analyzed for oxylipin levels, tendon stiffness, or pain levels at each assessment is not reported in the registry record. Without those counts, it is not possible to judge how much the outcome summaries may reflect incomplete follow-up or whether missing observations were concentrated at particular times.
The study is identified as a pilot trial, and the registry lists no randomized comparison. Pilot biomarker observations can describe feasibility and patterns worth examining, but this record does not provide enough outcome or analysis information to quantify those patterns. The registry’s sample-size assumptions describe planning illustrations based on an observed effect and a two-arm framework; those illustrations are not observed power and are not the trial’s own design. The actual effect and the associated planning estimates are not reported in the registry record. Overall, the record identifies the questions and planned measures, but does not provide the numerical results needed to assess the primary endpoint.
9. Statistical Methods Explained
The registry identifies a continuous primary outcome summarized by a mean and standard deviation. For a continuous measure, the mean is the arithmetic average of the observed values. The standard deviation describes the spread of those values around the mean. A mean can make a group’s typical level easier to describe, while the standard deviation indicates whether measurements tend to cluster closely or vary widely. These summaries are descriptive; by themselves, they do not quantify the uncertainty in a change estimate or establish a cause.
Change over repeated assessments can be summarized in different ways. An analysis might compare group means at each time point, estimate within-person changes, or fit a model that uses repeated measurements together. These approaches answer related but not identical questions and rely on different assumptions. The registry’s stated primary outcome is change in oxylipin levels at baseline, three months, and six months, but the statistical method used to estimate that change is not reported in the registry record.
What does a confidence interval add?
A confidence interval conveys uncertainty around an estimated quantity, such as a mean or a change. It is not a guarantee that the true value lies within the interval, nor does it show the range of individual participant measurements. A narrower interval generally indicates greater precision under the analysis assumptions; a wider interval indicates less precision. Because the registry does not report a confidence interval for the primary outcome, the precision of any change estimate cannot be evaluated from this record.
Why does the single-group design matter?
In a single-group study, measurements are observed over time without a separate randomized control group. A time pattern can be described, but a before-and-after difference does not isolate the effect of a treatment. Other influences may also change during follow-up, and repeated measurements may vary because of measurement error or natural fluctuation. Random assignment and a concurrent comparison can help separate treatment-related differences from other influences; neither is described for this study. The registry lists allocation as NA and masking as none.
How should repeated measurements be handled?
Measurements from the same participant are often related. General statistical methods for repeated measures account for this relationship rather than treating every measurement as independent. A model may also use incomplete follow-up under specified assumptions, but its interpretation depends on how missingness is handled and on the model being appropriate. The registry record does not report whether repeated-measures methods were used, how within-participant correlation was handled, or what assumptions were made about missing observations. It is therefore not possible to assess those aspects of the analysis.
What do the planning assumptions mean?
The registry describes sample-size planning illustrations based on an observed effect, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It states that the effect to detect is a specified fraction of the observed effect. Such calculations are planning illustrations, not observed power: they describe hypothetical future-study requirements under stated assumptions, rather than the probability that this completed trial detected an effect. The record does not report the observed effect or numerical planning estimates. In addition, the stated two-arm planning framework does not match the listed single-group design, so those illustrations should not be read as a description of how participants were assigned in this trial.
Statistical significance and clinical importance are also distinct. A test result, if reported, would address compatibility with a statistical null hypothesis under an analysis model; it would not alone determine whether a change is important to patients. Interpretation would also require the estimated magnitude, its uncertainty, the measurement context, and a meaningful threshold if one were established. The registry does not report an interpretation threshold or numerical endpoint results.
Finally, analytical choices such as baseline adjustment, outlier handling, transformations, and the use of all available observations can influence estimates for continuous outcomes. These are general considerations, not claims about this study’s procedures. The registry record does not report those methods, a statistical analysis plan, or the model used for the primary outcome. The stated mean and standard deviation identify the planned summary format, but do not resolve how the time-course analysis was conducted.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome, oxylipin levels, and two secondary outcomes, tendon stiffness and pain levels. It also records three outcome measures and three analyses. The statistical hypotheses and the relationship between those analyses and the listed outcomes are not reported in the registry record. It is not possible to determine whether the analyses were prespecified, whether each time point was tested separately, or whether one overall test was planned for change over time.
When several outcomes, time points, or statistical tests are examined, the chance of at least one apparently notable result can increase. Statistical approaches to multiplicity can adjust interpretation or testing, but the appropriate approach depends on the planned questions and analysis. No multiplicity adjustment or strategy for prioritizing outcomes is reported in the registry record. This absence does not show that no adjustment was used; it means the record does not state whether one was used.
The registry describes assessments at baseline, three months, and six months for the primary outcome, with additional timing for the listed blood and imaging assessments. It does not report participant counts contributing to each measure at each time point, reasons for missing observations, or methods for handling missing data. It also does not report an analysis population, such as whether the primary analysis included all enrolled participants or only those with specified measurements. These omissions limit assessment of whether incomplete follow-up could have affected the reported summaries.
Missing-data assumptions matter because analyses can be biased if the likelihood of an observation being missing is related to its unobserved value or to participant characteristics. This is a general statistical concern, not a finding about this study. The registry does not describe missingness patterns or sensitivity analyses. As a result, the impact of missing data on the primary and secondary outcomes is 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 |
|---|---|---|---|
| Participants | 0 | 28 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Participants | 0 of 28 |
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 |
|---|---|
| Participants | 0 of 28 |
The registry records 0 serious adverse events among 28 participants at risk and 0 other adverse events among 28 participants at risk. It also records 0 deaths. These entries describe the safety counts recorded in the registry; they do not provide detail about event definitions, collection procedures, or the period during which events were assessed. No top serious adverse-event terms are listed.
A recorded count of zero should be read as a registry result, not as proof that an event was impossible or that no event could occur outside the recorded assessment. The registry does not report the severity criteria, attribution rules, surveillance schedule, or whether all participants were followed for safety over the same duration. It also does not provide confidence intervals for the event counts. The precision of the safety estimates therefore cannot be evaluated from the registry record.
These safety figures do not establish a comparative safety profile. The study is single group and has no separate control group, so the counts cannot be used to compare risks between assigned treatments. They should be interpreted as the recorded event totals in this study, with the limitations of the reported information.
12. What the Result Does, and Does Not, Mean
The record describes a completed pilot study of blood- and imaging-based biomarkers in patients with breast cancer scheduled to start adjuvant hormonal therapy. The primary outcome is oxylipin levels at baseline, three months, and six months. The listed secondary outcomes are tendon stiffness and pain levels. These details identify what the study set out to assess, but the registry record does not report numerical results for those outcomes.
Without outcome estimates, it is not possible to say whether oxylipin levels, tendon stiffness, or pain levels changed, in which direction they changed, or how precisely any change was estimated. The absence of numerical results in the registry record is not evidence that there was no change. It means the outcome findings cannot be evaluated from the information recorded there.
The design also limits the conclusions that could be drawn from a time pattern. Because the study is single group and has no randomized comparator, differences across assessment times would not by themselves establish that hormonal therapy caused the differences. A biomarker association would also not, on its own, show that the marker predicts symptoms or can guide clinical decisions. The registry record does not report a validation analysis or a threshold for interpreting biomarker values.
The record reports enrollment and safety counts, but not the number of participants contributing data to each outcome at each time point, the statistical model, or handling of missing observations. These details affect how a result should be interpreted. The study can be understood as an assessment of biomarker and symptom measures over time in a defined clinical context; the posted information does not support conclusions about treatment effectiveness, causal effects, or the clinical utility of the biomarkers.
13. Why This Trial Matters Statistically
This study is statistically relevant because it brings together repeated blood measurements, imaging assessment, and symptom outcomes in a pilot setting. The stated primary outcome, oxylipin levels, is a continuous measure observed at baseline, three months, and six months. Describing how such a marker varies over time can help frame later questions about its measurement, variability, and relationship to clinical features. The record also identifies tendon stiffness and pain levels as secondary outcomes.
Repeated measurements raise important analysis questions. Observations from the same person can be correlated, follow-up may be incomplete, and outcome variability can influence how precisely changes are estimated. A clear analysis plan and reporting of estimates, uncertainty, and participant counts would help readers judge these issues. The registry record does not report those details, so it identifies the statistical questions without resolving them.
The single-group structure is also important. It may describe the course of measurements in this study group, but it cannot provide a randomized contrast with a control group. Any temporal pattern would need cautious interpretation because time, other care, and measurement variability can also contribute to observed differences. This distinction is central when moving from biomarker description to causal claims.
The record’s planning assumptions are framed around a two-arm design, whereas the trial itself is listed as single group. That makes it especially important to keep hypothetical planning illustrations separate from the study’s actual design and observed evidence. Overall, the study’s statistical value lies in its biomarker-focused repeated assessment question; the registry record does not include the numerical results needed to judge the observed patterns or their precision.
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 registry record provides the study’s broad design, scheduled assessments, and outcome names, but key details needed to assess the results are not reported. Numerical results for oxylipin levels, tendon stiffness, and pain levels are not reported in the registry record. There are no reported estimates of change, measures of uncertainty, or statistical test results for these outcomes. Consequently, neither the direction nor the magnitude of any observed pattern can be assessed.
The study has no separate control group and is listed as single group, with allocation NA and no masking. This prevents a randomized between-group comparison and limits causal interpretation of any time trend. The record does not describe the hormonal therapy regimen or whether it varied across participants. It also does not report detailed eligibility criteria beyond the population description, or how participants were recruited.
Follow-up and analysis details are also limited. The registry does not report the number of participants with outcome data at each time point, the number included in each analysis, reasons for missing observations, or methods for addressing missing data. It does not state whether the analysis used participant-level repeated-measures methods, adjusted for baseline values, or followed a prespecified analysis plan. No multiplicity strategy is reported for the listed outcomes and analyses.
Finally, the registry’s planning assumptions describe a two-arm framework, while the study design is single group. Numerical planning estimates and the observed effect used to generate them are not reported in the registry record. These limitations do not establish that the study lacked procedures or analyses; they identify what cannot be evaluated from the record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluation of Blood/Imaging Based Biomarkers, Aromatase Inhibitor Induced Musculoskeletal Syndrome — NCT03665077.
- Registry record last updated 2023-08-24; status last verified 2023-08.
- Results first posted 2023-08-14.
- 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
The registry describes a completed single-group pilot trial sponsored by the University of Arizona, with enrollment of 28. Participants are described as patients with breast cancer who completed primary treatment and were scheduled to start adjuvant hormonal therapy. The study start date is 2018-02-28, and the primary completion date is 2022-06-15.
Assessments include blood draws and SWE ultrasound. The primary outcome is oxylipin levels in pg/mL at baseline, three months, and six months, summarized by a mean and standard deviation. Tendon stiffness and pain levels are listed as secondary outcomes. The registry records 0 serious adverse events, 0 other adverse events, and 0 deaths.
Numerical results for the primary and secondary outcomes, analysis methods, missing-data procedures, and outcome-specific analysis counts are not reported in the registry record. The record therefore describes the study question and design, but does not allow assessment of the magnitude or precision of outcome changes.