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 Assessing Patient-reported & Patient-related Outcomes in Randomized Cancer Trials for Older Adults (NCT03676218), a registered phase not stated study. The primary outcome is Number of Domains Considered Relevant by the Panel of Experts When Assessing Treatment Efficacy in Randomized Cancer Trials for Older Patients With Cancer.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03676218 |
| Phase | Phase not stated |
| Condition | Cancer |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 14 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Institut Bergonié |
| Results posted | Yes |
2. Clinical Question
Population
The project concerns older patients with cancer participating in randomized cancer trials. The registry describes the enrolled participants as experts involved in an international panel, rather than patients assigned to treatment groups.
Intervention
There is no therapeutic intervention under evaluation. The registry lists “Elderly cancer patients” as an “OTHER” intervention and describes experts providing recommendations about outcomes for trials involving older patients with cancer.
Comparator
No comparator group is reported. The registry record does not describe a like-for-like treatment comparison or state an allocation method.
Primary question
Which domains did the expert panel consider relevant when assessing treatment efficacy in randomized cancer trials for older patients with cancer? The recorded outcome is the number of relevant domains, while the outcome description names domains selected by the panel.
This is a question about outcome selection, not a test of whether one cancer treatment is better than another. The initiative addressed a measurement problem: tumor-centered endpoints may not reflect all outcomes relevant to older patients, whose circumstances can include comorbidities, non-cancer-related deaths, treatment toxicity, and preferences that may differ from those of younger adults. The registry says the panel reviewed literature concerning relevant patient-reported and patient-related domains and tools available to assess them.
The outcome description says that the panel based its selections on published guidance from scientific societies and regulatory authorities, as well as recommended minimum datasets for randomized trials involving older adults with cancer. The record therefore frames the primary question as a structured expert assessment informed by existing guidance. It does not report how panel members were selected, how agreement was assessed, or whether a formal consensus procedure was used.
3. Trial Design
The record describes the DATECAN-ELDERLY initiative as an expert-panel project concerned with outcomes for randomized cancer trials involving older adults. It does not describe a randomized treatment trial. The registered intervention is categorized as “OTHER,” and its description identifies experts involved in a panel providing recommendations about definitions of time-to-event outcomes for trials involving older patients with cancer. The brief summary also says that the experts reviewed literature on patient-reported and patient-related outcomes and available assessment tools.
The registry records enrollment of 14 and identifies the participants as experts involved in the panel. The record does not explain how this enrollment figure relates to panel membership, whether all enrolled experts completed the work, or how experts were recruited. A treatment allocation method and a control arm are not stated. The registry explicitly cautions that the arms are not a like-for-like control comparison, so treatment-effect comparisons and between-arm interpretations are not appropriate.
The record gives a start date of 2017-09-01, a primary completion date of 2023-12-01, and a status of COMPLETED. The primary outcome timeframe is described as 1 year after constitution of the panel; the date of constitution is not reported in the registry record. The registered primary outcome is the number of domains considered relevant by the panel. Its description names domains, but no numerical primary outcome value is reported.
The registry does not report a protocol, a statistical analysis plan, a sample-size justification, or an analysis population definition. It also does not describe whether the literature review was systematic, what process was used to reach panel decisions, or how disagreement was resolved. These omissions limit the ability to evaluate the project as a reproducible measurement-development process.
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 | Participants Involved in the Panel of International Experts |
|---|---|
| STARTED | 14 |
| COMPLETED | 14 |
| NOT COMPLETED | 0 |
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: 14 experts participated in the panel
| Characteristic | Unit | Participants Involved in the Panel of International Experts |
|---|---|---|
| Participants analysed | 14 | |
| Age, Customized: older than 18 years | Participants | 14 |
| Sex: Female, Male: Female | Participants | 8 |
| Sex: Female, Male: Male | Participants | 6 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: France | participants | 5 |
| Region of Enrollment: United Kingdom | participants | 1 |
| Region of Enrollment: Netherlands | participants | 1 |
| Region of Enrollment: Singapore | participants | 1 |
| Region of Enrollment: Belgium | participants | 2 |
| Region of Enrollment: United States | participants | 1 |
| Region of Enrollment: Italy | participants | 1 |
| Region of Enrollment: Norway | participants | 1 |
| Region of Enrollment: Canada | participants | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Domains Considered Relevant by the Panel of Experts When Assessing Treatment Efficacy in Randomized Cancer Trials for Older Patients With Cancer, measured over 1 year after the consitution of the panel of experts.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | geriatric domains |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is described as the number of domains that the expert panel considered relevant when assessing treatment efficacy in randomized cancer trials for older patients with cancer. Its unit is geriatric domains, and the recorded parameter is NUMBER. The outcome description says selection was based on published guidelines from scientific societies and regulatory authorities and on minimum datasets recommended for trials that include older adults with cancer.
The description names functional autonomy, cognition, depression, and nutrition. It also names health-related quality of life, patients’ symptoms, and satisfaction. These domains extend attention beyond tumor-centered measures and reflect aspects of health and experience that may matter when evaluating treatments in older patients. The registry’s background notes that older adults with cancer may have comorbidities, non-cancer-related deaths, treatment toxicity, and preferences that differ from those of younger adults.
A domain count can describe the breadth of topics selected, but it does not by itself show how well a particular instrument measures any domain, how important each domain is to patients, or whether an outcome changes with treatment. The record provides no numerical value for the primary endpoint, no uncertainty estimate, and no scoring or aggregation details. Thus, the endpoint’s definition and the domains named in its description are available, but the panel’s numerical count and the precision of that count are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted record is best read as a description of an expert initiative and its intended outcome framework, not as evidence from a randomized treatment comparison. The registry identifies a primary outcome concerning the number of domains considered relevant, and its description names domains selected by the panel. It does not report the numerical value of that outcome. Consequently, the result cannot be interpreted as a quantified estimate of how many domains the panel endorsed.
The distinction between an endpoint definition and an endpoint result matters. A description of selected domains tells readers what topics the record associates with the panel’s work. A numerical outcome would show the value recorded for the named count endpoint. Because that value is absent, no conclusion about the magnitude of the endpoint can be drawn from the record. The registry also reports zero analyses, and it does not provide a statistical comparison, confidence interval, p-value, or other measure of uncertainty.
The listed domains are clinically oriented areas that the record says the panel considered relevant: functional autonomy, cognition, depression, nutrition, health-related quality of life, patients’ symptoms, and satisfaction. This list is evidence about the scope of the outcome description, not a ranking of domains or an indication that each was measured using a specific tool. The record does not give domain-level results, importance weights, patient preference data, or performance characteristics for assessment instruments.
The project’s rationale is that commonly used efficacy endpoints are often tumor-centered and may not capture outcomes important to older patients. That rationale explains why broader measures may be considered in trial design. It does not establish that any particular endpoint is valid, feasible, responsive to treatment, or preferable for every cancer trial involving older adults. Those questions require supporting evidence that is not reported in the registry record.
Likewise, the registry does not report a treatment effect, safety comparison, or patient outcome resulting from an intervention. The project is not described as assigning patients to competing therapies. Therefore, the posted information cannot support a claim that a treatment works or does not work. It also cannot quantify the benefit or harm of an outcome-measurement strategy.
The record states that the panel drew on published guidance and recommended minimum datasets. That provides context for the stated basis of domain selection, but the record does not identify the specific guidance, explain how conflicting recommendations were handled, or document the panel’s decision process. The status COMPLETED indicates the registered project is marked complete; it does not supply the missing numerical outcome or analysis. Interpretation should therefore remain descriptive and limited to the stated purpose, endpoint definition, and domain names.
9. Statistical Methods Explained
The registry describes an expert-panel initiative, not a conventional randomized comparison of treatments. That distinction determines which statistical ideas are relevant. The primary outcome is framed as a count of domains considered relevant. The record gives the outcome definition and named domains but no numerical count, distribution, or analysis. Statistical concepts can clarify what such an outcome would represent, but they cannot fill in the missing result.
What does a count endpoint represent?
In general, a count endpoint records how many items meet a defined criterion. For this project, the stated criterion concerns whether a domain was considered relevant by the panel. The interpretation depends on clear rules for what qualifies as a domain, how a panel decision is recorded, and whether a domain is counted once or handled in another way. The registry record does not report these operational details. It names domains in the outcome description, but does not give a numerical count as the result.
A count is not automatically a measure of importance. If domains are counted equally, the count describes breadth, not the relative value of each domain. It also does not establish that the domains were measured, that instruments were validated, or that a trial using them would be more informative. Those are separate measurement and design questions. The record does not report weights, rankings, or domain-specific scores.
How would uncertainty be assessed?
In general, a confidence interval expresses the range of values compatible with an estimate under a specified statistical model and sampling process. For an expert-panel count, interpretation of uncertainty would depend on what is treated as the source of variation: for example, variation across experts, across panels, or across repeated decision processes. The registry does not state a sampling model or report a confidence interval. Without a numerical estimate and an analysis method, precision cannot be assessed.
General methods for count data may account for discreteness and for variation that is larger than a simple model expects. Over-dispersion means that observed variability exceeds what a model assumes; ignoring it can make uncertainty appear smaller than it is. This issue is relevant only when a suitable count dataset and model are available. The record reports neither a count distribution nor a model, so there is no basis to say whether over-dispersion was present or whether any count-data method was used.
Was there a treatment-effect analysis?
No treatment-effect analysis is reported. The registry cautions that the arms are not a like-for-like control comparison and says allocation is not stated. Its intervention description concerns experts involved in a panel, not patients assigned to therapies. Consequently, methods for comparing treatment groups, estimating relative effects, or interpreting group differences cannot be applied to the posted outcome description.
The record lists 1 outcome measure and 0 analyses. These entries do not reveal a statistical model, an estimation strategy, or a plan for handling uncertainty. The statistical plan is not reported in the registry record. Nor does the record report interim analyses, adjustments, or a sample-size justification. These details should not be inferred from the project’s completion status or its endpoint label.
What do the planning assumptions mean?
The registry’s planning description refers to illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It also specifies that time-to-event illustrations use a total number of events, while other illustrations use participants per arm. These are described as planning conventions, not as the project’s own design. The record does not give an observed comparative effect or numerical planning results for this expert-panel outcome. Such illustrations are not observed power and do not constitute evidence about the panel’s result.
In general, a sample-size calculation depends on a defined outcome, a target effect, variability or event assumptions, a significance level, desired power, and design features. Planning illustrations can show how a hypothetical study might be sized under stated assumptions; they do not establish that a study had that size, that the assumptions were met, or that an analysis was sufficiently informative. In this record, no arm-based treatment comparison is described, so the generic two-arm planning assumptions should not be mistaken for the panel’s design.
The missing analysis details are especially important for reproducibility. The record does not say whether decisions were made independently before discussion, how consensus was defined, whether all panel members assessed every domain, or how incomplete assessments would be handled. It also does not report a protocol or analysis population. These are not merely technical details: they determine what the count means and how broadly it can be interpreted.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 1 outcome measure and 0 analyses. It does not report a multiplicity strategy, such as whether different outcomes or comparisons were treated as a family or whether any adjustment was planned. The listed primary endpoint is a count of relevant domains, but the outcome description also names individual domains. The record does not say whether those domains were separate analytic outcomes, descriptive components, or simply part of the endpoint’s explanation. Therefore, the impact of multiple testing cannot be assessed from the registry record.
Missing-data methods are not reported. The record does not state whether panel assessments were incomplete, how missing responses would be identified, or how any incomplete information would affect the endpoint. This absence is not evidence that missing data occurred; it means that the registry does not describe a handling plan or report the completeness of panel assessments.
Analysis populations and denominators are also not defined. Although enrollment is recorded as 14 and participants are described as experts involved in the panel, the record does not specify which participants contributed to the primary outcome or whether every enrolled expert completed each assessment. It does not report an analysis set, exclusions, or a flow of participants through the panel process.
These limitations matter because a count based on panel judgments depends on how judgments were collected and combined. Without information on completeness, decision rules, and the analysis population, readers cannot assess whether the endpoint represents all enrolled experts or a subset. The registry record also does not report sensitivity analyses or alternative ways of handling uncertain or incomplete judgments.
11. What the Result Does, and Does Not, Mean
The record supports a limited descriptive understanding of the initiative: it concerned outcome domains for randomized cancer trials involving older patients, and an expert panel considered domains informed by published guidance and recommended minimum datasets. The outcome description names functional autonomy, cognition, depression, nutrition, health-related quality of life, patients’ symptoms, and satisfaction. The record marks the project COMPLETED and records enrollment of 14 experts involved in the panel.
The posted information does not report the numerical value of the primary outcome. It therefore does not establish the panel’s numerical count of relevant domains, quantify the panel’s agreement, or describe the precision of any count. It also does not show whether each domain was endorsed by all experts or how the panel reached its decisions. The names of domains in the description should not be read as evidence of a measured patient outcome or a validated instrument.
The initiative’s rationale highlights why tumor-centered endpoints may not capture all concerns relevant to older patients with cancer. This provides a reason to consider broader outcomes in trial planning, but it does not show that any specific domain or measurement tool is suitable in every setting. Nor does it demonstrate that using these domains changes treatment decisions or improves patient outcomes.
No treatment comparison is reported, and the registry does not describe patients assigned to different therapies. The record therefore says nothing about the efficacy or safety of a cancer treatment. It cannot support claims for or against any treatment, or estimates of treatment benefit or harm. The most defensible interpretation is that the registry documents the purpose and stated scope of an expert-panel effort while leaving its numerical primary result and statistical analysis unreported.
12. Why This Trial Matters Statistically
Statistically, the initiative addresses a question that precedes treatment-effect estimation: which outcomes should trials measure? An endpoint can be analyzed rigorously only after its meaning, measurement, and role in the trial have been specified. The project’s focus on patient-reported and patient-related domains recognizes that tumor-centered measures may not represent every outcome relevant to older adults with cancer.
The domains named in the registry span function, cognition, mood, nutrition, quality of life, symptoms, and satisfaction. Considering such areas can broaden the scope of outcome planning beyond disease progression alone. In general, this can help researchers distinguish what a treatment does to a tumor from how illness and treatment affect patients’ lives. The record, however, describes domain selection rather than evidence that these domains were measured or that a specific endpoint is validated.
The project also illustrates why transparent reporting of endpoint-development methods matters. Readers need to know how experts were selected, how literature and guidance were reviewed, how judgments were collected, and how consensus was reached. A clearly defined outcome and reproducible decision process make it easier to evaluate whether the selected measures are relevant and whether future trials can use them consistently. Those methodological details are not reported in this registry record.
The statistical significance of the initiative is therefore primarily conceptual: it focuses attention on outcome relevance in a population that the registry says is underrepresented in randomized cancer trials. The record does not provide a numerical result or inferential analysis, so its contribution cannot be quantified from the posted information. Its stated scope can inform questions for trial design, but it does not establish the measurement properties or treatment effects of any outcome.
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 principal limitation for interpreting this registry record is that the primary outcome is defined but its numerical result is not reported. No uncertainty estimate, distribution, or analysis accompanies the endpoint. The registry marks the project completed, but completion status does not resolve the absence of a result.
The record gives limited detail about how the expert panel worked. It does not report how experts were recruited or selected, their relevant characteristics, whether they assessed domains independently, how consensus was defined, or how disagreement was addressed. The enrollment figure is recorded as 14, but the record does not explain which experts contributed to each decision or assessment.
The outcome description refers to guidelines and recommended minimum datasets, but does not identify the specific sources or explain how they were applied. It does not report a protocol, a systematic review method, a formal consensus method, or a statistical analysis plan. It also does not state whether the named domains were ranked, weighted, or assessed with particular instruments.
The timeframe is described as 1 year after constitution of the panel, but the constitution date is not reported in the registry record. The record does not state how missing or incomplete panel assessments were handled, define an analysis population, or describe sensitivity analyses. These limitations restrict reproducibility and make it difficult to assess the robustness or generalizability of the panel’s decisions. They do not establish that the process was inadequate; they identify information not reported in the registry record.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Assessing Patient-reported & Patient-related Outcomes in Randomized Cancer Trials for Older Adults — NCT03676218.
- Registry record last updated 2025-10-03; status last verified 2025-09.
- Results first posted 2025-10-03.
- 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
NCT03676218 is the DATECAN-ELDERLY initiative, sponsored by Institut Bergonié and marked COMPLETED. The registry records a start date of 2017-09-01, a primary completion date of 2023-12-01, and enrollment of 14. Participants are described as experts involved in a panel addressing outcomes for randomized trials involving older patients with cancer.
The primary outcome concerns the number of domains considered relevant by the panel. Its description names functional autonomy, cognition, depression, nutrition, health-related quality of life, patients’ symptoms, and satisfaction, and says domain selection drew on published guidance and recommended minimum datasets. The numerical primary outcome result is not reported in the registry record.
The record does not describe a like-for-like treatment comparison, reports 1 outcome measure and 0 analyses, and does not provide a statistical analysis plan, uncertainty estimate, or treatment-effect result. Its information supports a description of the initiative’s purpose and stated domains, but not a quantitative conclusion about the panel’s endpoint.