Characteristics of Sexual Dysfunction in Patients With Lung Cancer: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Characteristics of Sexual Dysfunction in Patients With Lung Cancer (NCT06018376), a registered phase not stated study. The primary outcome is Number of Participants With Different Type, Frequency and Severity of Sexual Dysfunction.

2. Clinical Question

The study’s stated purpose is descriptive. It aims to characterize sexual dysfunction in people with lung cancer and to use findings to inform strategies for clinical management and oncological follow-up. That objective is distinct from testing whether a treatment causes, prevents, or changes sexual dysfunction: the registry record does not describe randomized treatment assignment or a control group designed for such a comparison.

The eligibility description narrows the population to people within the stated age range, with lung cancer in stages IB to IV, prior systemic oncological treatment for at least 3 months, and ECOG status no higher than 2. The registry record does not report further demographic characteristics or the number of eligible patients who were assessed, approached, or enrolled at each stage. Although enrollment is listed as 553, the record does not report outcome data that would establish how many participants contributed to the primary measure.

The primary question is therefore about the distribution of a health experience in a defined clinical population, not a comparative treatment effect. The registry record gives the intended outcome and its timeframe, but it does not report estimates of type, frequency, or severity. Those omissions prevent a numerical answer to the study question from being drawn from the posted results.

3. Trial Design

NCT06018376 is recorded as a completed observational study sponsored by Fundación GECP. The registry lists enrollment of 553 and one observational study group. It does not describe random allocation, an assigned treatment, or a control group suitable for a like-for-like comparison. Systemic oncological treatment is listed as the intervention, but in this context it describes treatment received by participants rather than an intervention assigned by the study.

The group description specifies adults aged 18 to 70, diagnosed with lung cancer stages IB to IV, who had received systemic oncological treatment for at least 3 months and had ECOG status no higher than 2. The registry record does not report how these eligibility criteria were operationalized, how participants were recruited at individual sites, or whether additional exclusion criteria applied.

The record gives a study start date of 2023-07-13 and a primary completion date of 2024-02-29. Its summary describes recruitment from July 2023 through December 2023 and analysis of information from January to March 2024. These dates describe the planned or recorded study timeline; they do not establish when each participant completed assessment or how long follow-up lasted for each person.

The primary outcome timeframe is stated as from inclusion up to 3 months. The registry identifies the outcome as the number of participants with different types, frequency, and severity of sexual dysfunction. It does not report the assessment instrument, the specific categories used, the exact assessment schedule, or the analysis population. The study status is completed, but no primary outcome results or statistical analyses are posted in the registry record. Completion status alone does not indicate that results were reported or that the intended analysis was performed.

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

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.

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants With Different Type, Frequency and Severity of Sexual Dysfunction, measured over From inclusion up to 3 months.

The primary endpoint is described as the number of participants with different types, frequency, and severity of sexual dysfunction. Its unit is participants, and its timeframe is from inclusion up to 3 months. This is a descriptive endpoint: it is intended to characterize an outcome within the enrolled population rather than estimate a difference between assigned treatments.

Counts can communicate how many participants fall into defined outcome categories. To interpret such counts, readers also need the denominator for each assessment and clear definitions of the categories. For a frequency estimate, for example, the number meeting a defined outcome must be considered in relation to the number assessed for that outcome. This is a general statistical point; the registry record does not report category definitions, denominators, or calculated frequencies.

The registry classifies the outcome as binary and describes the parameter as a count of participants. That classification does not by itself explain how multiple types or severity levels were handled, whether participants could be counted in more than one category, or how missing assessments were treated. Those details are not reported in the registry record.

A descriptive endpoint is useful when the objective is to document the pattern of an experience in a clinical population. It can provide a basis for further study and care-planning questions, but its interpretation depends on measurement methods, complete outcome data, and appropriate denominators. Because no outcome results are posted, the record does not establish the observed number of participants in any dysfunction category or the precision of those estimates.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record describes a descriptive observational study, but does not report a detailed statistical analysis plan or analysis results. The following points explain the relevant statistical concepts and distinguish them from methods documented for this study.

What a count can describe

A count records how many participants meet a specified definition. For an outcome with several types or severity levels, each category needs a clear operational definition. If categories are mutually exclusive, participants are assigned to one category; if categories can overlap, a participant may contribute to more than one count. These choices affect what the counts mean. The registry record does not report the categories or whether overlap was allowed.

Counts alone do not show how common an outcome is unless the number of participants assessed is also known. A count may be paired with a denominator to describe frequency, and uncertainty may be expressed with an interval estimate. These are general approaches, not confirmed methods for this study. The record lists enrollment of 553 but does not report the denominator for the primary outcome or a frequency estimate.

Binary outcome classification

The registry classifies the primary outcome as binary and identifies the parameter as a count of participants. In general, a binary measure distinguishes whether a defined event or condition is present or absent. The outcome description also refers to different types and severity, which may involve more than a single yes-or-no classification. The registry record does not explain how those aspects were reconciled in coding or analysis. It is therefore not possible to infer the detailed statistical representation from the classification alone.

Precision and interpretation

A point estimate, such as a count or proportion, describes the observed data. A confidence interval is a general method for showing the uncertainty associated with an estimate under a statistical model. Its width depends on factors such as the amount of usable information and the variability of the outcome. No confidence interval or other precision measure for the primary endpoint is reported in the registry record. Without outcome estimates and denominators, precision cannot be assessed.

For counts or proportions, interpretation also depends on whether observations are independent and whether the sample represents the population to which readers might wish to generalize. These are general considerations. The registry record does not describe recruitment sites, sampling procedures, participant clustering, or any adjustment for such features. It therefore does not permit an assessment of representativeness or of whether a particular model would be appropriate.

Comparisons and causal interpretation

In general, comparative analyses require groups that can be meaningfully contrasted and methods suited to the study design. Random allocation can help support causal comparisons, while observational comparisons remain vulnerable to differences between groups and other sources of confounding. This study is recorded as observational, and the registry identifies no like-for-like control comparison. The treatment listing should not be read as evidence of treatment assignment. No comparative effect estimate is reported.

The record’s planning description refers to an illustrative sample-size calculation based on a fraction of an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. It also distinguishes the total number of events used for time-to-event illustrations from participants per arm for other illustrations. Those are planning assumptions, not the study’s reported design justification or observed results. The record does not report an observed effect estimate or a trial-specific sample-size justification. The illustrations therefore cannot be interpreted as observed power or as evidence that the study had adequate precision for its descriptive objective.

What is documented

The registry reports zero statistical analyses and no primary outcome results. It does not report a named statistical test, model, estimation method, confidence interval, adjustment procedure, or software. These omissions mean the analysis actually used cannot be reconstructed from the registry record. General concepts can clarify what would be needed to interpret descriptive findings, but they do not establish that any particular method was applied to these participants.

10. Multiplicity, Missing Data and Analysis Populations

The registry record does not report how multiplicity was handled. The primary outcome refers to type, frequency, and severity, but the record does not specify the number of categories or analyses planned for these dimensions. It also does not report whether subgroup analyses or secondary comparisons were planned. When many outcomes or comparisons are examined, the chance of at least one apparently notable finding can increase; statistical approaches can address that issue, but no such approach is reported for this study.

Missing-data methods are also not reported. The record does not state how many participants completed an assessment, whether outcome information was missing, why any information was missing, or whether participants with incomplete assessments were included in particular analyses. It does not describe imputation, complete-case analysis, sensitivity analysis, or another approach. These are possible general methods, not methods confirmed for this study.

The analysis population is not reported. The registry gives enrollment of 553 and eligibility criteria, but does not identify which participants contributed to the primary endpoint or whether the analysis used all enrolled participants. The primary outcome’s timeframe is from inclusion up to 3 months, but the record does not explain whether assessments at different times were combined or how incomplete follow-up was handled.

These details matter because outcome counts and frequencies depend on who was assessed and how missing observations were treated. Without a defined denominator, category rules, and analysis population, readers cannot establish whether the reported enrollment corresponds to the population used for any outcome estimate. No primary result is posted, so these uncertainties cannot be resolved by examining reported analyses.

11. What the Result Does, and Does Not, Mean

The study’s stated purpose is to describe sexual dysfunction among patients with lung cancer who had received systemic oncological treatment and met the listed eligibility criteria. The registry record reports that the study is completed and lists enrollment of 553. It does not report the primary outcome results, so it does not show how many participants experienced sexual dysfunction, which types were recorded, how often they occurred, or how severity was distributed.

The record also does not provide estimates of precision or the denominators needed to interpret counts as frequencies. Completion status is not a substitute for an outcome report. Nor does enrollment alone demonstrate that every enrolled participant contributed data to the primary endpoint.

The observational design and absence of a like-for-like control group mean that the study record does not support a causal claim about systemic oncological treatment. It does not establish that treatment caused or changed sexual dysfunction, and it does not compare treatment strategies. The objective of informing clinical management and follow-up is not itself evidence that the study evaluated a specific strategy.

These limits do not mean that the intended descriptive question is unimportant. They mean that the registry record, as posted, cannot answer it with numerical findings. To interpret the study’s results, readers would need outcome estimates, definitions, denominators, information on missing data, and a description of the analyses. None of those primary outcome details is reported in the registry record.

12. Why This Trial Matters Statistically

Sexual dysfunction is the focus of this study in a population defined by lung cancer diagnosis, treatment history, age, and performance status. A descriptive study can be statistically valuable by clarifying what outcomes should be measured and how they vary within a population. Such information may help frame subsequent research questions. The registry states that the intended findings were to inform strategies for clinical management and oncological follow-up, but does not report findings that could be used to evaluate that aim.

The study also illustrates why enrollment and completion status are not enough to interpret a clinical research record. A reader needs the outcome definition, the number assessed, the observed count or frequency, and a measure of uncertainty to understand what the study found. Without those elements, a completed study remains an incomplete source for evaluating the descriptive question.

Statistically, the distinction between description and comparison is central. This registry record identifies an observational group and no suitable control comparison. Its purpose, as recorded, is characterization rather than estimation of a treatment effect. Maintaining that distinction prevents a treatment listing or an intended clinical application from being mistaken for comparative evidence.

The record also makes clear the importance of reporting analysis populations, missing-data handling, and category definitions when an outcome includes multiple dimensions such as type and severity. Without these details, even a future numerical summary could be difficult to interpret. The study’s topic and stated objective are clear, but the posted record does not contain the results needed to assess the magnitude, distribution, or precision of the 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 primary limitation for interpretation is that no primary outcome result is reported in the registry record. Although the outcome is defined in broad terms and enrollment is listed as 553, there are no outcome counts, frequencies, severity estimates, or precision measures. The record therefore cannot support a numerical description of sexual dysfunction in the enrolled population.

The endpoint description does not specify the assessment instrument, category definitions, or whether participants could be represented in multiple categories. The population field for the primary outcome is blank, and the analysis population is not otherwise identified. The record also does not report the number assessed at each time point, the completeness of follow-up, or methods for handling missing observations.

Generalizability is difficult to evaluate because the record does not describe recruitment sites or sampling methods. The stated eligibility criteria limit the population to adults aged 18 to 70, lung cancer stages IB to IV, at least 3 months of systemic oncological treatment, and ECOG status no higher than 2. The posted record does not establish how the enrolled participants compare with people outside those criteria.

The observational design does not provide a randomized treatment comparison, and the record identifies no like-for-like control group. It cannot establish a causal effect of treatment. Statistical methods and a detailed analysis plan are not reported, while the registry lists no analyses. Finally, the adverse-event summary’s zero at-risk count leaves the safety entries uninterpretable as participant-level evidence. These limitations concern what can be learned from the registry record; they do not establish what may appear in other study materials.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: Characteristics of Sexual Dysfunction in Patients With Lung Cancer — NCT06018376.
• Registry record last updated 2026-02-06; status last verified 2026-02.
• Results first posted 2026-02-06.
• 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.

17. Record Summary

NCT06018376, “Characteristics of Sexual Dysfunction in Patients With Lung Cancer,” is recorded as a completed observational study sponsored by Fundación GECP. Enrollment is listed as 553. The study group comprised people aged 18 to 70 with lung cancer stages IB to IV, at least 3 months of systemic oncological treatment, and ECOG status no higher than 2.

The primary outcome concerns the number of participants with different types, frequency, and severity of sexual dysfunction, from inclusion up to 3 months. The recorded study dates are 2023-07-13 for the start and 2024-02-29 for primary completion. The study summary describes recruitment from July 2023 through December 2023 and information analysis from January to March 2024.

No primary outcome results or statistical analyses are reported in the registry record. The record does not describe a randomized or like-for-like control comparison.