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 Mast Cell Activation Test in Allergic Disease (NCT03406325), a registered phase not stated study. The primary outcome is Evaluation of Patient's Serum for Autoreactivity on Normal Average Responder Mast Cell Activation.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03406325 |
| Phase | Phase not stated |
| Condition | Asthma, Mastocytosis, Mast Cell Activation Syndrome |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 19 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Hong Kong Sanatorium & Hospital |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled 19 patients with allergic disease or mast-cell-related conditions. The conditions listed include asthma, mastocytosis, mast cell activation syndrome, food allergy, chronic idiopathic urticaria, anaphylaxis, and eczema. Serum was obtained from all 19 patients; 12 were in a validation group, while the other 7 were studied more extensively and their data were reported individually.
Intervention
The evaluation used a blood-based laboratory test. Patient serum was incubated with mast cells derived from normal donors, and histamine release was used as evidence of mast cell activation. The record describes mast cells studied after 9 weeks in culture. This is a diagnostic-test investigation, not a treatment comparison.
Comparator
The study summary says results would be compared with data collected from healthy control blood donors. The registry record does not report a randomized control group, and allocation is not stated. The relationship between those healthy-donor data and the enrolled patient groups is not reported in the registry record.
Primary question
The central question is whether patient serum produces detectable autoreactivity, measured through histamine release when incubated with normal average-responder mast cells. The investigators also hypothesized that functional activation profiles of cultured mast cells could help predict the potential state of mast cell activation in the person. The primary outcome is a participant count; the registry record does not report the count of participants with the primary finding or a diagnostic-performance estimate.
This is an early evaluation of a proposed laboratory approach in disease groups where the investigators expected mast cell activation to be relevant. It asks whether a laboratory response can be observed under the described assay conditions and whether such responses may be informative about disease-related activation. Those questions are distinct from demonstrating that a test accurately classifies patients in clinical practice. The registry record does not report a prespecified diagnostic threshold, sensitivity, specificity, predictive values, or a comparison of test performance against an independent clinical reference standard. Consequently, the posted information does not establish how well the assay distinguishes affected patients from healthy controls or among the listed conditions.
3. Trial Design
The registry record describes a completed pilot study, with enrollment of 19 and a status of completed. The listed study dates are 2018-02-01 for the start and 2019-12-01 for primary completion. The sponsor is Hong Kong Sanatorium & Hospital. The study summary describes a translation of earlier in-vitro work into disease groups in which mast cell activation was expected to be high, including highly allergic individuals, people with chronic idiopathic urticaria, mastocytosis, and mast cell activation syndrome.
The enrolled patients were divided in the registry description into a validation group of 12 and 7 patients studied more extensively, whose data were reported individually. Condition-specific arm descriptions identify patients with urticaria, asthma, eczema, food allergy, anaphylaxis, mastocytosis, and mast cell activating syndrome. The registry record does not report the number of patients in each condition or how patients were assigned to these groups. It also does not report whether individuals could have more than one listed condition.
The study is not described as a randomized comparison; allocation is not stated. The disease groups therefore should not be treated as randomized arms or as like-for-like control groups. The summary says results would be compared with data collected from healthy control blood donors, but the registry record does not report whether those donors were enrolled in this trial, how many there were, or the details of that comparison. No treatment assignment or treatment effect is described.
The primary outcome evaluates patient serum for autoreactivity on normal average-responder mast cell activation. Serum was incubated with mast cells derived from normal donors, with histamine release serving as evidence of activation. The registry record does not report the laboratory procedures beyond this description, the assay threshold, blinding procedures, or the analysis plan. Although six outcome measures are listed, the registry record does not report the results for the primary outcome or the other outcomes. It also does not report a statistical analysis for the posted results.
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.
Only the first 6 of 8 groups are shown.
Overall Study
| Stage | Validation Group | SH#1 | SH#2 | SH#3 | SH#4 | SH#5 |
|---|---|---|---|---|---|---|
| STARTED | 12 | 1 | 1 | 1 | 1 | 1 |
| COMPLETED | 12 | 1 | 1 | 1 | 1 | 1 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Mast cells were cultured from blood of normal donors to validate the (Mast Cell Activation) MAT assay. The serum samples were obtained from allergic patients with sensitivities to Der p2 and used for passive sensitization of normal donor mast cells followed by their activation by Der p2 allergen. Data were collected only from the validation group.
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: During recruitment period, no participants with asthma, food allergy, mastocytosis were recruited.
Only the first 6 of 9 groups are shown.
| Characteristic | Unit | Validation Group | SH#1 | SH#2 | SH#3 | SH#4 | SH#5 |
|---|---|---|---|---|---|---|---|
| Participants analysed | 12 | 1 | 1 | 1 | 1 | 1 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 12 | 1 | 1 | 1 | 1 | 1 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male: Female | Participants | 9 | 0 | 0 | 1 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 3 | 1 | 1 | 0 | 1 | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 12 | 1 | 1 | 1 | 1 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment: Hong Kong | participants | 12 | 1 | 1 | 1 | 1 | 1 |
| Clinical diagnosis: Eczema | Participants | 4 | 1 | 1 | 1 | 0 | 0 |
| Clinical diagnosis: Rhinitis | Participants | 5 | 0 | 0 | 0 | 0 | 0 |
| Clinical diagnosis: Urticaria | Participants | 3 | 0 | 0 | 0 | 0 | 0 |
| Clinical diagnosis: Exercise-induced anaphylaxis | Participants | 0 | 0 | 0 | 0 | 0 | 1 |
| Clinical diagnosis: Mast cell activation syndrome | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Clinical diagnosis: Eczema and Urticaria | Participants | 0 | 0 | 0 | 0 | 1 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Evaluation of Patient's Serum for Autoreactivity on Normal Average Responder Mast Cell Activation, measured over Mast cells studied after 9 weeks in culture.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is titled “Evaluation of Patient's Serum for Autoreactivity on Normal Average Responder Mast Cell Activation.” It is expressed as a count of participants. In the assay described in the registry record, patient serum was incubated with mast cells derived from normal donors, and histamine release was treated as evidence that mast cell activation had occurred. The mast cells were studied after 9 weeks in culture.
This endpoint addresses a laboratory question: whether serum from a patient can provoke an activation response under the assay conditions. It was chosen to investigate the proposed blood-based test and the hypothesis that functional activation characteristics may reflect a person’s potential in-vivo mast cell activation state. Histamine release provides a measurable indicator for the laboratory response described in the record; it is not, by itself, a direct measurement of all mast cell activity in the body or of clinical symptoms.
The registry record identifies serum from 19 patients, including a validation group of 12 and 7 patients studied more extensively. However, it does not report the primary endpoint result, the count meeting any assay criterion, or the criterion used to classify a response. It also does not report a clinical reference standard or a diagnostic-accuracy analysis. Without those details, the endpoint’s observed value and its precision cannot be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes that 19 patients were enrolled in a pilot investigation of a serum-based mast cell activation assay. It describes the laboratory approach and the primary outcome as a count of participants whose serum showed autoreactivity through histamine release. It does not report the primary endpoint result. Therefore, the posted record does not show how many participants had a response, how that response varied across the listed conditions, or how patient results compared with healthy control donor data.
No effect estimate, confidence interval, p-value, or statistical analysis is reported in the registry record. This absence matters because a count alone would not indicate how precisely the response frequency was estimated, nor would it show whether differences between groups might reflect random variation. The record also does not report subgroup counts by disease condition. It is not possible to infer patterns across asthma, food allergy, eczema, anaphylaxis, urticaria, mastocytosis, or mast cell activation syndrome from the enrolled total.
The distinction between laboratory response and diagnostic performance is important. Histamine release in an assay is the stated evidence of mast cell activation for the primary endpoint. A diagnostic claim would additionally require information about the test classification rule and how classifications correspond to an appropriate reference assessment. Sensitivity, specificity, predictive values, and agreement with a reference standard are not reported in the registry record. The described hypothesis that cultured mast-cell activation profiles could predict in-vivo activation remains a hypothesis in the posted information, rather than a result demonstrated by a reported analysis.
The validation group and the 7 patients studied individually have different descriptions, but the registry record does not explain the analysis strategy for those groups. There is no reported estimate of between-group variation or evidence that one group was used to evaluate a rule developed in another. As a result, the label “validation group” should not be taken as proof that diagnostic validation was completed or successful.
The registry’s adverse-event entries report zero serious adverse events in the validation group and in each individually listed patient group, and zero deaths. These counts describe the safety information posted in those entries. They do not provide evidence about assay accuracy or clinical benefit. The registry record does not report further safety detail, such as the observation period or a broader accounting of non-serious events.
Overall, the posted information supports a description of a small pilot assay investigation, but not a quantitative conclusion about the primary endpoint. The absence of reported outcome results and analyses prevents assessment of the size, direction, and precision of any assay response. It also prevents determining whether the proposed test distinguishes patient samples from healthy donor data.
9. Statistical Methods Explained
What does a participant count represent?
The primary outcome is defined as a count of participants. A count records how many people meet a stated outcome definition; interpretation depends on the definition, the number assessed, and whether all enrolled participants contributed usable measurements. Here, the registry record describes histamine release as evidence of mast cell activation but does not report the criterion that determined whether a participant counted as having the endpoint. It also does not report the endpoint count. The count therefore cannot be reconstructed or interpreted as a response rate from the posted record.
Why do laboratory definitions matter?
An assay result depends on how samples are handled and how a positive response is distinguished from background variation. The registry description states that patient serum was incubated with mast cells derived from normal donors and that histamine release indicated activation. It also specifies that mast cells were studied after 9 weeks in culture. The record does not report the laboratory threshold, replicate procedures, assay variability, blinding, or quality-control criteria. These details are relevant because they help readers understand how reproducible measurements were and how borderline results were classified. Their absence from the registry record limits appraisal of the endpoint’s measurement properties.
What would an estimate and confidence interval add?
In general, an estimate summarizes the observed result, while a confidence interval describes the uncertainty associated with that estimate under the assumptions of the analysis. For a participant count or proportion, uncertainty depends in part on how many people were assessed and how many met the outcome definition. A narrow interval would indicate greater precision than a wide interval, while neither alone establishes that a test is clinically useful. The registry record does not report an endpoint estimate or confidence interval, so the precision of the primary result cannot be evaluated.
What can a significance test establish?
In general, a significance test assesses how compatible observed data are with a specified statistical model or null hypothesis. Its interpretation depends on the comparison, assumptions, and analysis plan. A p-value does not measure the size of an effect, the probability that a hypothesis is true, or the clinical importance of a finding. No p-value, hypothesis test, or statistical analysis is reported in the registry record. The planned comparison with healthy control blood donor data is mentioned in the study summary, but its analysis is not described.
Why is over-dispersion sometimes relevant?
In general, over-dispersion occurs when count data vary more than a chosen statistical model expects. If a model assumes a particular degree of variation but the data are more dispersed, standard errors and inferences can be unreliable unless the model accounts for that extra variation. This issue can arise in some count-data settings, but the primary outcome is a participant count, and no model or analysis is reported. It is therefore not possible to say whether over-dispersion was assessed or relevant to the investigators’ analysis.
How should sample-size illustrations be read?
General sample-size calculations illustrate how many participants might be needed to detect a specified effect under stated assumptions. They are planning aids, not observed results and not evidence that a study had a particular probability of finding an effect. The posted planning illustrations use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the target effect is described as a stated fraction of the observed effect. The record does not report that these assumptions formed the trial’s original design or sample-size justification. The study’s sample-size justification is not reported in the registry record. Any planning illustration should therefore be read separately from the enrolled total of 19 and not as observed power.
More broadly, interpretation of a pilot study depends on transparent reporting of its outcome definitions, comparison structure, missing observations, and analysis methods. The registry record does not report a statistical analysis plan, the number contributing data to each outcome, or estimates of uncertainty. Those omissions mean that general statistical principles can explain what information would be useful, but they cannot fill in the missing trial results.
10. Exact Estimates for Each Arm
No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.
| Arm | Participants | Events | Observed % | Clopper-Pearson 95% CI | Wilson 95% CI | Bayesian 95% credible interval |
|---|---|---|---|---|---|---|
| Validation Group | 12 | 0 | 0.0% | 0.0% to 26.5% | 0.0% to 24.2% | 0.2% to 24.7% |
| SH#1 | 1 | 1 | 100.0% | 2.5% to 100.0% | 20.7% to 100.0% | 15.8% to 98.7% |
| SH#2 | 1 | 0 | 0.0% | 0.0% to 97.5% | 0.0% to 79.3% | 1.3% to 84.2% |
| SH#3 | 1 | 0 | 0.0% | 0.0% to 97.5% | 0.0% to 79.3% | 1.3% to 84.2% |
| SH#4 | 1 | 0 | 0.0% | 0.0% to 97.5% | 0.0% to 79.3% | 1.3% to 84.2% |
| SH#5 | 1 | 0 | 0.0% | 0.0% to 97.5% | 0.0% to 79.3% | 1.3% to 84.2% |
R code and output
arm <- c("Validation Group", "SH#1", "SH#2", "SH#3", "SH#4", "SH#5")
n <- c(12, 1, 1, 1, 1, 1)
events <- c(0, 1, 0, 0, 0, 0)
for (i in seq_along(n)) {
ci <- binom.test(events[i], n[i])$conf.int # Clopper-Pearson exact interval
cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i]) # Bayesian, uniform Beta(1,1) prior
wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}
ARM Validation Group 12 0 0.0 0.0 26.5 0.0 24.2 0.2 24.7
ARM SH#1 1 1 100.0 2.5 100.0 20.7 100.0 15.8 98.7
ARM SH#2 1 0 0.0 0.0 97.5 0.0 79.3 1.3 84.2
ARM SH#3 1 0 0.0 0.0 97.5 0.0 79.3 1.3 84.2
ARM SH#4 1 0 0.0 0.0 97.5 0.0 79.3 1.3 84.2
ARM SH#5 1 0 0.0 0.0 97.5 0.0 79.3 1.3 84.211. Multiplicity, Missing Data and Analysis Populations
The registry record lists six outcome measures, but it does not report how many hypotheses were tested, which outcomes were designated for formal statistical testing, or whether any adjustment for multiple comparisons was planned. When multiple outcomes or subgroup comparisons are examined, the chance of finding an apparently notable result by chance can increase. In general, a prespecified multiplicity strategy helps readers understand how confirmatory claims were protected against that risk. No such strategy is reported in the registry record, and no statistical analyses are posted from which to assess how multiplicity was handled.
The registry description identifies a validation group of 12 and 7 patients studied more extensively, but it does not state whether these groups were defined before data review or how they entered the analysis. It does not report an intention-to-diagnose or other analysis population, exclusions, or numbers with available assay measurements. Whether all 19 enrolled patients contributed to each endpoint is not reported in the registry record.
Missing-data methods and the amount or pattern of missing data are also not reported in the registry record. In general, missing measurements can affect an estimate if participants without results differ from those with results. Without participant flow and outcome completeness information, the extent of any such concern cannot be assessed. The registry record also does not report how repeated or individually presented observations were summarized for analysis. These gaps limit evaluation of whether the reported population, if any, represents all enrolled patients.
12. 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 |
|---|---|---|---|
| Validation Group | 0 | 12 | 0.0% |
| SH#1 | 0 | 1 | 0.0% |
| SH#2 | 0 | 1 | 0.0% |
| SH#3 | 0 | 1 | 0.0% |
| SH#4 | 0 | 1 | 0.0% |
| SH#5 | 0 | 1 | 0.0% |
| SH#6 | 0 | 1 | 0.0% |
| SH#7 | 0 | 1 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Validation Group | 0 of 12 |
| SH#1 | 0 of 1 |
| SH#2 | 0 of 1 |
| SH#3 | 0 of 1 |
| SH#4 | 0 of 1 |
| SH#5 | 0 of 1 |
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 |
|---|---|
| Validation Group | 0 of 12 |
| SH#1 | 0 of 1 |
| SH#2 | 0 of 1 |
| SH#3 | 0 of 1 |
| SH#4 | 0 of 1 |
| SH#5 | 0 of 1 |
The adverse-event entries report zero serious adverse events in the validation group, which lists 12 participants at risk, and zero serious adverse events in each individually listed group, each of which lists 1 participant at risk. The entries also report zero deaths for the validation group and each individual group. No top serious adverse terms are listed.
These are the safety counts posted in the registry record; they do not establish that no adverse events of any kind occurred. The registry record does not report a broader non-serious adverse-event summary, the method for collecting events, or the duration of safety observation. The listed groups are not randomized treatment arms, and the record describes a diagnostic assay investigation rather than a treatment comparison. Safety counts therefore should not be interpreted as comparative treatment effects.
Zero reported serious events is a descriptive finding within the recorded groups. It does not show that an assay or any clinical procedure is risk-free, and it does not address diagnostic performance. The small enrollment and the absence of detail about event ascertainment also limit how much can be concluded from the counts. The relevant interpretation is confined to what the registry record lists: no serious adverse events or deaths were entered for these groups.
13. What the Result Does, and Does Not, Mean
The study is relevant as a pilot investigation of whether a laboratory mast-cell response can be measured using patient serum and cultured mast cells from normal donors. The posted description links histamine release to assay evidence of activation and sets out the investigators’ hypothesis that functional activation profiles may reflect a person’s potential in-vivo mast cell activation. It also describes an interest in gene-expression biomarkers correlated with disease. These are scientific aims, not findings established by the record.
The record does not report the primary endpoint count, results for the other listed outcomes, gene-expression findings, or a statistical analysis. It therefore cannot show whether patient serum produced activation in the assay, whether results differed across disease groups, or whether any gene-expression biomarkers were associated with those conditions. The planned comparison with healthy control blood donor data is mentioned, but the comparative results are not reported in the registry record.
The investigation also does not establish diagnostic performance. A laboratory response is not equivalent to demonstrating that a test correctly identifies or excludes a clinical condition. Such an evaluation would require a defined test classification approach and comparison with a suitable reference assessment. The registry record does not report these elements or diagnostic accuracy estimates.
Nor does the record establish clinical utility or treatment benefit. It describes no therapeutic intervention and no randomized clinical comparison. The sample-size illustrations associated with planning should not be read as observed power or as proof that the study was designed to detect a specific clinical effect. The study’s sample-size justification is not reported in the registry record.
Accordingly, the posted information supports understanding the pilot’s rationale, population, assay concept, and recorded adverse-event counts. It does not support a conclusion about the test’s accuracy, reliability, ability to predict in-vivo activation, or usefulness for clinical decisions. Those conclusions would require results and methods that are not reported in the registry record.
14. Why This Trial Matters Statistically
This trial raises several statistical issues that are central to early diagnostic-test research. First, the distinction between an assay signal and a clinically meaningful classification must be explicit. Histamine release is the laboratory indicator named for the primary endpoint, but its interpretation depends on a prespecified criterion and a comparison standard. Without those elements, a count of participants with a laboratory response cannot be translated into diagnostic accuracy.
Second, a pilot study can inform feasibility and generate hypotheses, but its results require careful attention to precision. Enrollment was 19, with 12 patients in a validation group and 7 studied more extensively. The registry record does not report the endpoint count or uncertainty interval, so readers cannot judge the precision of the primary result. Small samples can make estimates unstable, particularly when investigators examine multiple conditions or outcomes; the record does not report condition-specific counts or multiplicity procedures.
Third, the comparison structure matters. The summary refers to data from healthy control blood donors, while the patient arms are condition-defined and allocation is not stated. These groups should not be interpreted as randomized treatment arms. A statistical comparison would require clear information on how donor data were selected, measured, and analyzed, but those details and results are not reported in the registry record.
Finally, transparent reporting of analysis populations, missing assay results, and the test classification rule is essential for reproducibility. Those items are not reported in the registry record. The trial is therefore statistically informative as an example of a pilot assay question and its reporting needs, but the posted record does not allow the magnitude or reliability of the assay findings to be assessed.
15. 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 most important limitation for interpretation is that the registry record does not report results for the primary endpoint, despite describing the assay and the enrolled population. It also does not report results for the other five listed outcome measures or the planned comparison with healthy control blood donor data. Without outcome values, there is no basis in the posted record to assess the direction or size of an assay response.
The endpoint definition is incomplete for independent interpretation. Histamine release is identified as evidence of mast cell activation, but the record does not report a cutoff, classification rule, handling of borderline results, or assay reproducibility. It does not report whether laboratory staff were blinded to patient group or what quality-control procedures were used. The duration of 9 weeks in culture is stated, but other assay procedures are not reported in the registry record.
The population and group structure also limit interpretation. Enrollment was 19, with 12 in the validation group and 7 studied individually, but the record does not report condition-specific enrollment counts or whether conditions overlapped. Allocation is not stated, and the study is not a randomized comparison. Although healthy control blood donor data are mentioned in the summary, the record does not report their number, selection, or role in the analysis.
Finally, the registry record does not report a statistical analysis plan, sample-size justification, analysis population, missing-data accounting, or uncertainty estimates. It also does not report how multiplicity was addressed across six listed outcomes. These omissions preclude assessment of the precision, robustness, and reproducibility of the intended findings.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Mast Cell Activation Test in Allergic Disease — NCT03406325.
- Registry record last updated 2020-04-09; status last verified 2020-03.
- Results first posted 2020-04-09.
- 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.
19. Record Summary
The registry record describes a completed pilot study of a blood-based mast cell activation diagnostic test, sponsored by Hong Kong Sanatorium & Hospital. Enrollment was 19, with study dates listed as 2018-02-01 and 2019-12-01 for start and primary completion. The listed conditions include allergic and mast-cell-related diseases.
Patient serum was incubated with mast cells derived from normal donors, with histamine release used as evidence of activation. The primary endpoint is a participant count. The record identifies 12 patients in a validation group and 7 studied more extensively. It mentions comparison with healthy control blood donor data and a planned investigation of gene-expression biomarkers.
The registry record does not report primary or other outcome results, statistical analyses, diagnostic accuracy, or a sample-size justification. Adverse-event entries list zero serious adverse events and zero deaths in the recorded groups. These safety counts do not establish assay performance or clinical utility.