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 Effect of Celecoxib on Perioperative Inflammatory Response in Colon Cancer (NCT01284504), a randomized na study. The primary outcome is Tumor Sample - Analyzed for TCR Repertoire and Global Transcription Profiling.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01284504 |
| Phase | NA |
| Condition | Colorectal Cancer, Colon Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 1 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Stanford University |
| Results posted | Yes |
2. Clinical Question
Population
Patients with colon cancer undergoing primary resection of their tumors were the intended population. The registry describes the project as exploratory and planned to use blood and tumor samples to investigate immune and inflammatory responses. One patient was accrued and withdrawn after signing consent; none were treated.
Intervention
The intervention was celecoxib, described as a 200 mg tablet. The study aimed to examine its effect on the perioperative inflammatory response. The record does not report when treatment was to be given in relation to surgery, how long treatment was intended to continue, or the specific dosing schedule.
Comparator
The comparator was a placebo tablet. The study was registered as randomized, double-blind, and parallel-group. Because no participants were treated, the record does not contain an observed comparison of celecoxib with placebo.
Primary question
The primary outcome concerned tumor samples analyzed for T-cell receptor repertoire and global transcription profiling, with a stated timeframe of 2 years. The registry does not report results for these measures. The record therefore cannot show whether celecoxib changed these profiles or the perioperative inflammatory response.
3. Trial Design
The registry describes a randomized, double-blind, parallel-group trial comparing celecoxib with placebo. The study title and summary place the question in the setting of colon cancer surgery, with interest in the inflammatory response around the operation. The intervention is listed as celecoxib, 200 mg tablet, and the comparator as a placebo tablet. The record gives no further treatment schedule or details of how the treatment period related to surgery.
The registry lists the study as terminated. It records an enrollment of 1 and states that one patient was accrued and withdrawn after signing consent; none were treated. This distinction is central to interpreting the design: the intended randomized comparison is described, but the record does not document treated groups from which to estimate a treatment effect. The record does not report whether randomization occurred before withdrawal or provide allocation details for the accrued patient.
The phase is listed as NA. Stanford University is identified as sponsor. The listed study dates are 2011-01 for start and 2011-05 for primary completion. The registry does not report why the trial was terminated, the intended recruitment target, or a protocol-level account of enrollment and discontinuation. These omissions prevent a fuller assessment of whether the registered design was changed or why recruitment stopped.
The planned primary outcome involved tumor sample analysis for T-cell receptor repertoire and global transcription profiling. The summary also mentions blood samples and tumor samples, but the record does not describe specific laboratory procedures or analysis methods. A secondary outcome concerns surveys assessing pain, fatigue, and recovery, recorded from the day of surgery to 30 days post-op. The record lists three outcome measures, but does not provide results or identify the other measures in the information available.
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 | Celocoxib | Placebo |
|---|---|---|
| STARTED | 0 | 0 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: One patient was accrued and withdrawn after signing consent; none were treated.
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 | Celecoxib | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 1 | 0 | 1 | |
| Age, Categorical: <=18 years | Participants | 0 | — | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 1 | — | 1 |
| Age, Categorical: >=65 years | Participants | 0 | — | 0 |
| Sex: Female, Male: Female | Participants | 1 | — | 1 |
| Sex: Female, Male: Male | Participants | 0 | — | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | — | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | — | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | — | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | — | 0 |
| Race (NIH/OMB): White | Participants | 0 | — | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 | — | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | — | 0 |
| Region of Enrollment: United States | participants | 1 | — | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Tumor Sample - Analyzed for TCR Repertoire and Global Transcription Profiling, measured over 2 years.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The registered primary outcome is tumor sample analysis for T-cell receptor repertoire and global transcription profiling. These measurements are intended to characterize features of immune activity and gene expression in tumor tissue. In general, biological profiling can help researchers explore whether a treatment is associated with changes in pathways or immune-cell patterns relevant to a study question. Such measurements are exploratory indicators; their interpretation depends on the specific assays, prespecified summaries, timing, and statistical analysis.
The registry gives a timeframe of 2 years for this outcome, but does not clarify the precise timing of sample collection or how that timeframe applies to the analyses. It does not report the measured variables, scoring or normalization procedures, planned contrasts, or criteria for interpreting a change. The record also does not report endpoint results.
Most importantly, one patient was accrued and withdrawn after signing consent, and none were treated. There is therefore no treated-group tumor profile comparison reported in the registry. The endpoint title describes what the study intended to measure, not a finding about celecoxib. The registry record does not establish whether any planned tumor samples were collected or analyzed.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes an exploratory randomized comparison of celecoxib and placebo, but it does not report an efficacy estimate. One patient was accrued and withdrawn after signing consent; none were treated. As a result, there is no observed treated-group contrast to interpret for the primary tumor profiling outcome or the secondary survey outcome. No estimate of a treatment effect, confidence interval, or outcome analysis is reported in the registry record.
The primary outcome title identifies T-cell receptor repertoire and global transcription profiling of tumor samples, with a timeframe of 2 years. That description specifies the broad scientific intent but does not say what was observed. It does not identify a measured change, direction of effect, magnitude, variability, or statistical uncertainty. The record's brief summary describes the proposed investigation, not completed evidence about the treatment.
The registry lists a secondary outcome involving surveys of pain, fatigue, and recovery from the day of surgery to 30 days post-op. No survey results are reported. The record also lists three outcome measures, but the information available does not provide results for any of them. In the absence of treated participants and outcome data, there is no basis in the registry record for comparing symptom or recovery outcomes between groups.
The adverse-event listing records zero at risk and zero affected for serious and other events in each listed group. Because none were treated, these entries cannot be interpreted as evidence that treatment caused no adverse events or as a meaningful comparison of safety between groups. Death counts are not reported in the registry record. The data do not support a safety estimate.
Planning calculations based on an observed effect require an observed treatment contrast. The registry record reports no such contrast, and no sample-size values or outcome estimates are included in the registry record for this analysis. Any planning illustration should therefore not be read as observed evidence or as a measure of the study's achieved power. More generally, sample-size calculations describe assumptions for a future design; they do not substitute for an outcome analysis.
The key interpretation is limited but clear: the record documents a planned trial and its early termination, not comparative clinical or biological results. It does not show that celecoxib improved, worsened, or had no effect on inflammatory response, tumor profiles, pain, fatigue, recovery, or adverse events. Those conclusions would require analyzed outcome data that the registry record does not report.
9. Statistical Methods Explained
Randomization is a method for assigning participants to study groups by chance. In general, it is used to reduce systematic differences between groups at the outset, so that an outcome contrast can be interpreted as a treatment comparison under appropriate conduct and analysis. Here, the registry identifies the design as randomized, but one patient was accrued and withdrawn after consent and none were treated. The registry record does not report allocation details or an analyzed comparison. The intended randomization therefore does not yield a treatment-effect estimate in the information recorded.
Double masking means that the study is recorded as masking two parties, although the registry entries do not identify those parties. In general, masking can limit changes in behavior or assessment that might arise from knowing treatment assignment. A parallel-group design assigns participants to one of the study groups rather than planning a within-person crossover. Those design labels describe the planned structure; they do not by themselves establish that treatment was received or that valid comparative data were collected. The registry does not report how masking was maintained or assessed.
A treatment effect is generally estimated by comparing outcomes between groups, using a measure suited to the outcome type and study question. For a continuous biological measure, an analysis might compare group means or model changes, while a categorical or repeated-measures outcome may require a different approach. These are general examples, not methods reported for this trial. The statistical analysis plan, effect measure, model, covariate adjustment, and handling of repeated or multiple measurements are not reported in the registry record. With no treated participants and no outcome results reported, no such comparison can be reconstructed.
A confidence interval, in general, expresses the uncertainty around an estimated effect under the assumptions of the analysis. It helps readers distinguish a precise estimate from one compatible with a broad range of effects. A p-value, in general, measures how compatible the observed data are with a specified null model; it is not the probability that a treatment works or that the null hypothesis is true. Neither an effect estimate nor a confidence interval or p-value is reported for the trial outcomes. Without analyzed observations, none can be inferred from the design description.
Biological profiling can generate many measurements, such as features of T-cell receptor repertoires or transcription patterns. In general, analyzing many features creates a multiplicity issue: the more comparisons made, the greater the opportunity to identify apparently unusual results by chance. Strategies may include defining a primary feature in advance, controlling an error rate, or treating findings as exploratory. The registry record does not report the number of planned comparisons, a multiplicity procedure, or which findings would be considered confirmatory. The exploratory description is not a substitute for a stated analysis plan.
Over-dispersion is a general issue in which observed variability is greater than a simple statistical model assumes. If present, it can make standard errors too small and intervals too narrow unless the analysis accounts for the extra variability. The record does not report outcome distributions, variability estimates, or a model for the tumor profiling measures, so it is not possible to assess whether over-dispersion arose or how it would have been handled. This is a general consideration, not a finding about these data.
The study record includes planning assumptions for a sample-size illustration: a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the target effect expressed as a fraction of an observed effect. Such calculations are planning tools; they describe the sample size associated with chosen assumptions, rather than the probability that a completed study has detected a real effect. In this case, the registry entries do not report an observed treatment effect or calculated sample-size values. Because none were treated, an observed effect cannot be obtained from the recorded trial experience. These assumptions cannot be treated as the study's original design rationale, and the sample-size illustration cannot establish achieved power.
The registry does not report an interim analysis plan, stopping boundary, or protocol-based reason for termination. It also does not report the analysis population definitions, missing-data method, or primary statistical model. These details matter because analysis choices influence the interpretation of estimates, especially when outcome data are incomplete or several measures are considered. Their absence means that statistical methods beyond the broad design and planning assumptions are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome combines T-cell receptor repertoire analysis and global transcription profiling. These labels can encompass multiple measured features, but the registry does not specify the number of features, a hierarchy of outcomes, a primary contrast for each feature, or a method for controlling multiplicity. In general, when multiple hypotheses are tested, some apparently notable results may occur by chance. Prespecifying a primary analysis or using an appropriate multiplicity strategy can help clarify how findings should be interpreted. Neither approach is described in the registry record.
The record lists surveys of pain, fatigue, and recovery from the day of surgery to 30 days post-op, and indicates three outcome measures. It does not report the survey instruments, scoring rules, analysis timing, or any adjustment for testing multiple outcomes. It also does not provide results. The other listed measures are not described in the information available for this analysis.
One patient was accrued and withdrawn after signing consent; none were treated. The record does not explain whether any outcome data were collected before withdrawal or whether any samples were obtained. It does not report a missing-data strategy, reasons for missing outcome values beyond the withdrawal, or an approach to incomplete surveys. The status of unreported measurements is therefore not established.
Analysis populations are also not reported in the registry record. In general, an analysis might follow assigned groups, include only participants who received treatment, or apply another prespecified population definition. These choices can affect interpretation, particularly when participants withdraw or do not receive assigned treatment. The registry contains no outcome analyses with which to determine how the study would have applied such definitions.
11. What the Result Does, and Does Not, Mean
The registry record documents an exploratory trial intended to study celecoxib and perioperative inflammation in colon cancer surgery. It describes randomization, double masking, a parallel-group design, a celecoxib tablet, a placebo tablet, and planned tumor profiling. It also records termination and states that one patient was accrued and withdrawn after signing consent, with none treated. These registry entries describe the study's status and planned question, not its treatment effects.
The record does not show whether celecoxib changed T-cell receptor repertoire, global transcription profiles, or the broader inflammatory response. It does not report comparisons for pain, fatigue, or recovery, nor does it provide an estimate of adverse-event risk. Absence of results is not evidence of no effect. Likewise, zero adverse events recorded in groups with zero at risk cannot establish safety, particularly when no one was treated.
General statistical interpretation depends on the observed effect, its uncertainty, the outcome definition, and the analysis plan. Here, the registry record reports no outcome estimate, confidence interval, p-value, or completed comparison. The planned study design cannot compensate for the lack of treated participants and analyzed outcomes. Planning assumptions are not observed findings, and a sample-size illustration is not evidence of efficacy, safety, or achieved power.
The record also does not explain why the study was terminated or whether any samples or survey data were collected before withdrawal. These missing details limit conclusions about study conduct and data availability. The most defensible reading is that the registry describes an intended investigation that did not produce a reported treatment comparison. It cannot establish benefit, harm, or absence of an effect.
12. Why This Trial Matters Statistically
This trial matters statistically because its record illustrates the difference between a registered design and analyzable comparative evidence. Randomization and masking can strengthen a comparison when participants receive assigned treatments and outcomes are collected and analyzed. In this record, one patient was accrued and withdrawn after signing consent, and none were treated. The design labels therefore describe intent, not a completed experiment with an estimable contrast.
The planned tumor profiling also raises general analytic questions that are important in exploratory biological research. Repertoire and transcription analyses can involve many measurements, making outcome selection, multiplicity handling, and uncertainty reporting important for interpretation. The registry does not report those analysis details. Without them, and without outcome results, readers cannot assess how biological signals would have been distinguished from chance variation or how precisely any effect could be estimated.
The record also highlights why enrollment, treatment exposure, and outcome analysis should not be treated as interchangeable. A registered enrollment figure does not establish that participants received treatment, and a planned outcome does not establish that it was measured. Here, the registry explicitly reports withdrawal before treatment and no analyses. This sharply limits what can be learned about either efficacy or safety from the record.
Finally, planning assumptions should be separated from observed evidence. A sample-size illustration based on an observed effect is a design aid, not a result, and the registry entries do not report an observed treatment effect for this trial. Recognizing that distinction prevents planning calculations from being mistaken for evidence about the intervention.
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 most important trial-specific limitation is that no participants were treated. The registry reports that one patient was accrued and withdrawn after signing consent. This leaves no treated comparison for the primary tumor profiling outcome or the listed survey outcome. The record also does not explain the withdrawal or the reason for termination, so it is not possible to assess why the intended study did not proceed.
The primary endpoint description is broad: tumor samples were to be analyzed for T-cell receptor repertoire and global transcription profiling. The registry does not specify the particular measures, assay procedures, sampling schedule, or planned statistical contrasts. Although the timeframe is stated as 2 years, the record does not clarify the timing of sample collection and analysis. The scientific question is therefore more clearly described than the measurement and analysis strategy.
The record mentions blood and tumor samples in its summary, but does not report whether samples were collected or analyzed. It lists surveys assessing pain, fatigue, and recovery from the day of surgery to 30 days post-op, but does not report survey results, instruments, or scoring details. The other outcome measures are not described in the information.
There is no reported analysis plan, analysis population, missing-data method, or multiplicity procedure. No outcome estimates or measures of uncertainty are reported. The adverse-event entries do not support a safety assessment because none were treated, and deaths are not reported in the registry record. Taken together, these gaps mean that the record cannot support estimates of treatment effects, safety, or precision, and cannot establish whether any planned biological measurements were completed.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Effect of Celecoxib on Perioperative Inflammatory Response in Colon Cancer — NCT01284504.
- Registry record last updated 2018-03-16; status last verified 2018-02.
- Results first posted 2016-12-08.
- 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.
17. Record Summary
The registry describes a randomized, double-blind, parallel-group study of celecoxib versus placebo in patients undergoing primary tumor resection for colon cancer. Celecoxib was listed as a 200 mg tablet. The planned primary outcome was tumor sample analysis for T-cell receptor repertoire and global transcription profiling, with a stated timeframe of 2 years. A secondary outcome involved surveys of pain, fatigue, and recovery from the day of surgery to 30 days post-op.
The study is listed as terminated. The registry reports enrollment of 1 and states that one patient was accrued and withdrawn after signing consent; none were treated. No outcome analyses or results are reported. The record does not report the statistical analysis plan, reason for termination, or whether samples or survey data were collected. Consequently, it documents the intended study question and trial status but provides no comparative evidence about treatment effects or safety.