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 Arm Circumference Measurement With or Without Bioimpedance Spectroscopy in Finding Lymphedema Early in Patients With Stage I-III Breast Cancer (NCT03648983), a randomized na study. The primary outcome is Rates of Enhanced Lymphedema Detection.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03648983 |
| Phase | NA |
| Condition | Lymphedema, Breast Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 95 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Albert Einstein College of Medicine |
| Results posted | Yes |
2. Clinical Question
Population
Patients with stage I-III breast cancer undergoing axillary lymph node dissection or sentinel node biopsy were the intended study population. The registry lists enrollment as 95, but does not report analyzed participant characteristics or baseline records.
Intervention
The enhanced-detection group was scheduled for arm-circumference measurements and bioimpedance spectroscopy at 4, 10, 16, 22, 28, and 34 months.
Comparator
The standard-detection group was scheduled for arm-circumference measurement at the same assessment times, without bioimpedance spectroscopy.
Primary question
The planned comparison was the rate of enhanced lymphedema detection in the two groups during treatment, up to 34 months. The registry record does not report analyzed detection rates, so it does not establish whether the approaches differed.
The clinical question concerns detection, rather than a direct comparison of treatment for lymphedema. The registry describes a randomized, parallel-group pilot trial. It proposed comparing a measurement approach based on arm circumference alone with one that added bioimpedance spectroscopy to scheduled arm measurements. The intended participants had stage I-III breast cancer and were undergoing axillary lymph node dissection or sentinel node biopsy.
The clinical rationale in the registry is that diagnostic procedures such as bioimpedance spectroscopy may allow lymphedema to be found earlier than arm-circumference measurement alone. That is the motivation for the comparison, not a result. The primary outcome was the rate of enhanced lymphedema detection during treatment, with follow-up described as up to 34 months. The registry also lists severity of enhanced lymphedema and the percentage of subjects with complete resolution of signs of enhanced lymphedema as secondary outcomes.
The registry record states that the study was terminated because the principal investigator and study coordinator left the institution. It also states that no data were analyzed and participants’ baseline records were not available. Consequently, the clinical question remains unanswered by the posted results. Neither a between-group difference nor the frequency or timing of detection can be determined from this record.
3. Trial Design
This was a randomized, parallel-group pilot trial with no masking listed in the registry. The record lists the phase as NA and enrollment as 95. These are registry descriptors; the record does not provide an analyzed participant count or participant flow. It identifies Albert Einstein College of Medicine as the sponsor and lists the study status as terminated.
The two groups differed in the scheduled measurement method. In the standard lymphedema-detection group, participants were to undergo arm-circumference measurement at 4, 10, 16, 22, 28, and 34 months. In the enhanced-detection group, participants were to undergo both arm-circumference measurement and bioimpedance spectroscopy at those same times. The record describes arm circumference measurement as a procedure and bioimpedance spectroscopy as a device.
The registry lists a start date of 2011-11 and a primary completion date of 2015-08. The primary outcome timeframe is described as during treatment, up to 34 months. The record does not report whether the planned follow-up schedule was completed, how many participants received each measurement, or how many had outcome assessments.
The planned primary comparison was between detection rates in the enhanced and standard groups. The registry states that Fisher’s exact test would be used, with logistic and Cox proportional hazards regression models to adjust for potential imbalances in patient characteristics. These are planned analyses, not analyses reported as completed. The registry’s explanation for termination is that the principal investigator and study coordinator left the institution; it also explicitly states that no data were analyzed and baseline records were unavailable. Thus, randomization and the intended schedule describe the design, but the record does not establish how the study was implemented or what outcomes occurred.
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 | Study Population |
|---|---|
| STARTED | 95 |
| COMPLETED | 0 |
| NOT COMPLETED | 95 |
Reasons for not completing this period:
| Reason | Study Population |
|---|---|
| Study was terminated due to PI departure | 95 |
Analysis population for the primary outcome, as defined in the registry: \*\*\* Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.\*\*\*
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: Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.
| Characteristic | Unit | Study Population |
|---|---|---|
| Participants analysed | 0 | |
| Sex: Female, Male: Female | — | |
| Sex: Female, Male: Male | — | |
| Race (NIH/OMB): American Indian or Alaska Native | — | |
| Race (NIH/OMB): Asian | — | |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | — | |
| Race (NIH/OMB): Black or African American | — | |
| Race (NIH/OMB): White | — | |
| Race (NIH/OMB): More than one race | — | |
| Race (NIH/OMB): Unknown or Not Reported | — |
6. Primary Endpoint
The registry lists the primary outcome as Rates of Enhanced Lymphedema Detection, measured over During treatment (Up to 34 months).
| 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 was titled Rates of Enhanced Lymphedema Detection. It was intended to compare detection rates between the enhanced-detection group, which added bioimpedance spectroscopy to arm measurements, and the standard-detection group, which used arm measurements alone. The stated timeframe was during treatment, up to 34 months.
In general, a detection-rate endpoint can address whether a condition is identified under one monitoring approach compared with another. It is relevant to this trial because the registry’s stated rationale was that bioimpedance spectroscopy might enable earlier identification than arm-circumference measurement alone. However, the record does not define the operational criteria for an enhanced lymphedema detection event, specify how a rate would be calculated, or report endpoint results. Those details are not reported in the registry record.
The registry planned to compare the groups using Fisher’s exact test and described logistic and Cox proportional hazards regression models for adjustment for potential imbalances in patient characteristics. The record does not report that these analyses were performed. It states that no data were analyzed and that participants’ baseline records were unavailable. No detection counts, estimated effect, confidence interval, or p-value are reported. Therefore, the endpoint’s planned purpose can be described, but the registry cannot show the observed detection rate or whether the groups differed.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive fact is that the registry record reports no analyzed data. It states that the study was terminated because the principal investigator and study coordinator left the institution, and that participants’ baseline records were unavailable. Although the registry lists enrollment as 95 and describes the intended comparison, it provides no analyzed results for the primary outcome.
There are no posted primary outcome counts or estimates to compare between groups. The record does not report a treatment-group difference, a confidence interval, a p-value, or a measure of precision for the detection endpoint. It also does not report the number of participants with follow-up, the number with a detection event, or how outcomes were distributed over time. Without those results, the direction and size of any difference cannot be assessed. The absence of an analyzed result is not evidence that the approaches were equivalent or that neither detected lymphedema.
The methods named in the registry are plans: Fisher’s exact test for comparing detection rates and logistic and Cox proportional hazards regression models for adjustment for potential imbalances in patient characteristics. The record does not say that any of these analyses were completed. Accordingly, these methods should not be interpreted as producing estimates or conclusions for this trial. No adjusted or unadjusted analysis results are available in the registry record.
The secondary outcomes were severity of enhanced lymphedema and the percentage of subjects with complete resolution of signs of enhanced lymphedema. Their outcome results are not reported in the registry record either. The record lists three outcome measures and zero analyses, but does not provide a results dataset from which to assess any of them. Posted adverse-event counts are listed as zero for the study population; given the explicit statement that no data were analyzed, those entries should not be taken as evidence that no adverse events occurred.
In general, a confidence interval communicates the range of values compatible with an estimate under the statistical model and assumptions used. Here, there is no reported estimate or interval to interpret, so no assessment of statistical precision is possible. Likewise, no conclusion about clinical importance can be drawn without a reported effect and information about its uncertainty. The record supports a description of the planned design and intended endpoint, but not a comparison of observed outcomes or an effectiveness conclusion.
The registry’s sample-size assumptions describe a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. Such an illustration is not the trial’s own design justification. The record does not report an observed primary effect, and it says no data were analyzed. Any illustration tied to an observed effect should therefore not be read as evidence of the trial’s results, planned enrollment rationale, or observed power.
9. Statistical Methods Explained
The registry describes a randomized, parallel-group comparison with no masking listed. Randomization is intended, in general, to allocate participants to study groups in a way that reduces systematic differences at assignment. It does not guarantee that all characteristics will be balanced, particularly in a pilot study. The record says the planned analysis would adjust for potential imbalances in patient characteristics, but does not identify which characteristics would be included or report any fitted model.
What was the planned comparison?
The primary outcome was the rate of enhanced lymphedema detection in the group receiving arm measurements plus bioimpedance spectroscopy compared with the group receiving arm measurements alone. Assessments were scheduled at 4, 10, 16, 22, 28, and 34 months in both groups; bioimpedance spectroscopy was included only in the enhanced-detection group. The outcome timeframe was during treatment, up to 34 months. The registry does not describe a specific event definition or provide outcome counts.
Why name Fisher’s exact test?
In general, Fisher’s exact test is a method for comparing categorical outcomes between groups. It is often useful when the available event counts are small, because its calculation does not rely on the same large-sample approximation used by some other categorical-data tests. The registry names this test for comparing detection rates. That is a planned method, not a reported analysis: the record says that no data were analyzed. Without group counts, there is no test statistic or p-value to interpret.
What do the regression models add?
The registry states that logistic and Cox proportional hazards regression models would be used to adjust for potential imbalances in patient characteristics. In general, logistic regression models a binary outcome while allowing specified characteristics to be included as covariates. A Cox proportional hazards model is used for time-to-event outcomes and can incorporate information about the timing of events and follow-up. These models answer different statistical questions and rely on their own assumptions. The record does not say how the outcome would be represented in each model, which covariates were planned, or whether model assumptions would be assessed.
Adjustment can account for measured characteristics included in a model; it cannot correct unmeasured differences simply by being applied. Nor does naming a model establish that it was fitted. The registry provides no model estimates, uncertainty intervals, diagnostics, or participant-level data. Since no analyses were reported, the proposed regression methods cannot be used to infer an adjusted result.
What does a confidence interval generally convey?
In general, a confidence interval describes the uncertainty around an estimated effect under the analysis method and its assumptions. A narrower interval indicates greater statistical precision than a wider interval, while the interval’s position relative to a null value can help characterize compatibility with no difference. It does not, by itself, show whether an effect is clinically important or whether the study was free of bias. No confidence interval for the trial’s primary endpoint is reported in the registry record, so precision cannot be evaluated.
What is the relevance of time-to-event analysis?
In general, a time-to-event analysis uses information about when an event occurs, rather than only whether it occurred by the end of follow-up. It can also account for participants whose event status is not observed through the full follow-up period, when the analysis and assumptions support that approach. A Cox model is a common method for comparing event timing. The registry names a Cox proportional hazards model, but does not report event times, censoring information, a hazard estimate, or whether proportional-hazards assumptions were assessed. No time-to-event result can therefore be interpreted for this trial.
How should the planning illustration be read?
The registry describes planning assumptions for an illustration: 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 stated fraction of the observed effect, and distinguishes total events for time-to-event illustrations from participants per arm for other illustrations. These assumptions describe a planning calculation, not the trial’s own design or a reported sample-size justification. Sample-size illustrations are conditional on their assumptions; they do not show that a study achieved a particular power after it was conducted.
The record does not report the trial’s sample-size justification, a prespecified effect used in its design, or an observed effect. It also explicitly says no data were analyzed. Therefore, any planning illustration based on an observed effect cannot serve as an estimate of the trial’s outcome or as observed power. The registry lists enrollment as 95, but that entry does not establish how many participants were analyzed, how many were assigned to each group, or whether the planned measurements were completed.
Finally, statistical methods can only address data that are available and analyzed. Here, the registry states that baseline records were unavailable and that no data were analyzed. It does not report an analysis population, missing-data approach, model results, or sensitivity analyses. The named methods explain what the investigators planned to do, but they do not supply evidence about the primary question.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary outcome, Rates of Enhanced Lymphedema Detection, and two secondary outcomes: severity of enhanced lymphedema and percentage of subjects with complete resolution of signs of enhanced lymphedema. It lists three outcome measures and zero analyses. No results for the primary or secondary outcomes are reported.
The record does not report whether a multiplicity adjustment was planned for testing more than one outcome, whether the secondary outcomes were intended to be confirmatory or exploratory, or how multiple analyses would be interpreted. It also does not report whether there were additional planned analyses beyond the Fisher’s exact test and regression models described for the primary comparison. These details are not reported in the registry record, so the degree of protection against false-positive findings across multiple tests cannot be assessed.
The record explicitly states that participants’ baseline records were not available and that no data were analyzed. It does not describe the amount or pattern of missing follow-up data, any method for handling missing outcomes, or any sensitivity analysis. In general, missing-data methods depend on what information is missing and why it is missing; no such assumptions or methods are reported.
The analysis population is also not reported. The registry does not say how many participants were randomized, received the planned measurement procedures, completed follow-up, or contributed to a primary analysis. The enrollment entry of 95 does not, by itself, answer those questions. Since no analysis was conducted according to the record, the registry cannot establish whether the intended comparisons were based on all randomized participants or on a narrower group.
11. What the Result Does, and Does Not, Mean
The registry record describes a planned randomized comparison of two lymphedema-detection approaches in patients with stage I-III breast cancer undergoing axillary lymph node dissection or sentinel node biopsy. One group was scheduled for arm-circumference measurement alone, while the other was scheduled for arm-circumference measurement plus bioimpedance spectroscopy. Both schedules specified assessments at 4, 10, 16, 22, 28, and 34 months.
The record does not report the results needed to determine how often lymphedema was detected in either group, whether detection occurred earlier in one group, or whether the groups differed in the severity or resolution outcomes. It provides no effect estimate, confidence interval, or p-value for the primary endpoint. Therefore, it cannot show the size, direction, or precision of a difference between the approaches.
This absence of results should not be interpreted as a finding of no difference. It also does not show that the planned measurements were completed, that the approaches performed similarly, or that either approach was ineffective. The record states that the study was terminated because the principal investigator and study coordinator left the institution, that no data were analyzed, and that participants’ baseline records were unavailable. The posted information therefore documents an incomplete evidence record, not a comparative outcome finding.
More generally, a randomized design describes how a trial intends to compare groups; it does not substitute for reported outcome data. Statistical significance, clinical importance, and precision all require analyzable results. None can be evaluated from the information reported in this registry record. The appropriate interpretation is limited to the intended question, the planned measurement schedules, and the fact that no analyzed results are available.
12. Why This Trial Matters Statistically
This trial raises an important statistical distinction between a well-defined planned comparison and an answer supported by analyzed data. The registry identifies two measurement strategies, a primary detection outcome, a follow-up timeframe, and planned statistical methods. Those details clarify the question investigators intended to study. But the record also states that the study was terminated, no data were analyzed, and participants’ baseline records were unavailable. Without analyzed outcomes, the intended comparison cannot establish whether the approaches differed.
The design also illustrates why outcome definitions matter. A rate of enhanced lymphedema detection is named as the primary endpoint, but the registry does not report the operational definition of a detection event. Without that definition and group-level outcome data, readers cannot determine exactly what was counted or reproduce the intended comparison. Clear endpoint definitions are a general requirement for interpreting comparative studies, especially when the intervention changes how an outcome is measured.
The record names methods for both categorical comparison and adjustment, including Fisher’s exact test, logistic regression, and Cox proportional hazards regression. In general, these methods can address different aspects of a research question, such as whether an event occurred and when it occurred. Their presence in a protocol description does not produce evidence on its own. Results, uncertainty, and enough information about the analysis are needed to assess what the study found.
Finally, the trial highlights a practical limit on what randomization can accomplish. Random allocation can support a fair comparison when outcomes are collected and analyzed, but it cannot recover unavailable baseline records or replace missing results. For researchers and readers, distinguishing intended methods from completed analyses is essential. In this record, the statistical value is chiefly in understanding the proposed comparison and recognizing why no conclusion about comparative detection is available.
13. 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 is decisive: the registry states that no data were analyzed. It also states that participants’ baseline records were unavailable. As a result, no primary or secondary outcome estimates are reported, and the intended comparison cannot be evaluated. The record attributes termination to the principal investigator and study coordinator leaving the institution.
Important details needed to assess trial conduct are not reported in the registry record. These include participant flow, the number randomized to each group, the number completing scheduled measurements, follow-up completeness, and the number included in any outcome analysis. The registry’s enrollment entry of 95 does not provide those details. It also does not report the allocation method, concealment procedures, or whether the planned assessment schedule was completed.
The endpoint description does not specify the criteria used to classify enhanced lymphedema detection, or the exact calculation of the detection rate. The record does not report the planned covariates for adjustment, model diagnostics, missing-data procedures, or sensitivity analyses. It does not describe a sample-size justification for the trial. These omissions limit assessment of the planned methods, apart from the more fundamental absence of analyzed outcomes.
Although adverse-event counts are listed as zero, the registry’s statement that no data were analyzed means those entries cannot establish that no adverse events occurred. Overall, the record supports description of the intended pilot design, but not an assessment of recruitment, implementation, safety, outcome frequency, or comparative effect.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Arm Circumference Measurement With or Without Bioimpedance Spectroscopy in Finding Lymphedema Early in Patients With Stage I-III Breast Cancer — NCT03648983.
- Registry record last updated 2018-10-01; status last verified 2018-08.
- Results first posted 2018-10-01.
- 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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17. Record Summary
The registry describes a randomized, parallel-group pilot trial with no masking listed, comparing arm-circumference measurement alone with arm-circumference measurement plus bioimpedance spectroscopy. The intended population was patients with stage I-III breast cancer undergoing axillary lymph node dissection or sentinel node biopsy. Both groups were scheduled for assessments at 4, 10, 16, 22, 28, and 34 months.
The primary outcome was rates of enhanced lymphedema detection during treatment, up to 34 months. The registry also lists severity and complete resolution of signs of enhanced lymphedema as secondary outcomes. It lists enrollment as 95, a start date of 2011-11, primary completion of 2015-08, and status as terminated.
The record states that the principal investigator and study coordinator left the institution, no data were analyzed, and participants’ baseline records were unavailable. No comparative outcome results are reported, so the planned detection question remains unanswered by the posted record.