Use of a Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the AMC: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Use of a Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the AMC (NCT05510908), a registered phase not stated study. The primary outcome is Number of Cancers in People With HIV (PWH) Who Present for Care at Domestic AMC Sites.

2. Clinical Question

3. Trial Design

NCT05510908 is listed as a completed, non-interventional study sponsored by the AIDS Malignancy Consortium. The registry record lists enrollment of 460, a start date of 2023-07-25, and primary completion on 2025-02-28. These registry entries describe the study record; they do not by themselves provide outcome estimates or establish how many participants contributed to each analysis.

The study is intended to describe cancer burden and characteristics of PWH presenting for cancer care at domestic AMC sites. The intervention entries are “Non-Interventional” and “Non-Interventional Follow-up.” The record identifies three clinical-status groups: new, primary, or recurrent disease among people considering or currently receiving cancer treatment; metastatic or locally advanced cancer where definitive curative therapy is unavailable; and prior cancer diagnosed within 5 years and in remission, without current cancer treatment other than antiretroviral therapy or maintenance therapy. Allocation is not stated, and the registry record does not describe a randomized comparison. These categories should therefore be read as descriptive groups, not as treatment arms with a control relationship.

The primary outcome is a count of cancers among PWH presenting for care, with new and existing cases in each listed cancer group estimated per month during enrollment. Cancer groups include HPV-associated solid organ tumors, solid organ tumors unrelated to HPV, Kaposi sarcoma, and hematologic malignancies. The outcome description also specifies calculation of cancer-type percentages and comparison with the HACM Study distribution. Optional quality-of-life surveys are described as a way to learn about the effects of HIV, cancer, and cancer treatment. A secondary outcome concerns the percentage of participants eligible for AMC trials who are successfully enrolled.

The registry record does not report the recruitment process, site-level enrollment, follow-up completeness, or methods for handling participants who fall into more than one cancer category. A detailed protocol and statistical analysis plan are not reported in the registry record.

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 Cancers in People With HIV (PWH) Who Present for Care at Domestic AMC Sites, measured over Enrollment.

The primary endpoint measures the number of cancers among PWH who present for care at domestic AMC sites. The description calls for estimating new and existing cases per month during enrollment within four broad groups: HPV-associated solid organ tumors, solid organ tumors unrelated to HPV, Kaposi sarcoma, and hematologic malignancies. It also calls for describing the distribution of cancer types as percentages and comparing that distribution with the HACM Study.

A count is useful for describing how many cases a participating clinical network encounters. Grouping cancers can make the overall pattern more interpretable than listing every individual cancer separately, while percentages describe how the observed cases are distributed across the specified groups. The monthly framing is intended to describe case volume over time, but the registry record does not report the calculation method, the time units used in analysis, or whether monthly estimates were adjusted for changes in enrollment or site participation.

The record identifies the endpoint unit as participants and the measure as a count. It does not report the observed counts, monthly estimates, percentages, uncertainty intervals, or the comparison with the HACM Study. Consequently, the endpoint’s intended measurement is clear, but its observed magnitude and precision cannot be evaluated from the posted results. The registry record also does not report whether each person could contribute more than one cancer or how recurrent and existing cases were assigned to categories.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is a count of participants with cancer in specified groups. Counts answer a direct descriptive question: how many cases meeting the study’s definitions were identified? The registry describes estimating new and existing cases per month during enrollment and calculating percentages for the cancer-type distribution. It does not report the operational definitions, estimation procedure, or resulting values, so these should be understood as planned measures rather than reported findings.

What a count can describe

In general, a count reports the number of observed cases within a defined population and period. It does not automatically describe the underlying rate in a larger population. A rate requires an appropriate denominator and time at risk or exposure, and interpretation depends on how those quantities are defined. Here, the endpoint description uses monthly case estimates, but the registry record does not state the denominator, exact calculation, or whether the estimate is a simple count per month or a rate adjusted for the amount of observation.

Percentages describe the share of classified cases belonging to each cancer group. In general, percentages help compare the composition of a set of cases, but they do not show the absolute burden without the corresponding counts and denominator. Their interpretation also depends on mutually exclusive and consistently applied categories. The registry record does not explain whether cancer categories could overlap, how multiple cancers in one participant were handled, or how missing classifications were treated.

What the external comparison means

The outcome description proposes comparing the cancer-type distribution at AMC sites with the distribution in the HIV/AIDS Cancer Match (HACM) Study. This is a descriptive comparison between data sources, not a randomized treatment contrast. In general, a comparison is most interpretable when the populations, observation periods, case definitions, and classification rules align. Differences in those features can affect observed distributions. The registry record does not report whether or how alignment was assessed, nor does it provide the comparison results.

Uncertainty and precision

General statistical explanation: a confidence interval describes a range of values compatible with the data and a specified statistical procedure. It conveys uncertainty around an estimate; a narrower interval generally indicates greater precision under that procedure. No confidence intervals, standard errors, or other uncertainty estimates for the primary outcome are reported in the registry record. Without them, the precision of counts, percentages, or monthly estimates cannot be evaluated.

General statistical explanation: counts can vary more than a simple probability model expects when observations differ in risk or when cases cluster by site or time. This is called over-dispersion. If over-dispersion is present, methods that assume less variability may understate uncertainty. The registry record does not state whether over-dispersion was assessed or which statistical model, if any, was used. This is a general consideration, not a claim about the analysis conducted in this study.

Planning assumptions and observed results

The record describes a sample-size planning illustration based on an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. For time-to-event planning, the description refers to a total number of events using the Schoenfeld approach, while other settings are expressed as participants per arm. These are planning conventions, not evidence of the study’s own design or observed power. The record does not report a treatment comparison, an observed effect estimate, or numerical planning results. The study is described as non-interventional, with allocation not stated, so a two-arm allocation assumption should not be mistaken for a randomized trial design.

The registry record does not report a statistical analysis plan, model specification, adjustment variables, hypothesis-testing procedure, or interim analyses. It is therefore not possible to identify a method actually used to produce the intended monthly estimates or external comparison. General methods such as count models, standardization, or confidence-interval estimation should not be attributed to this study without such documentation.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists 11 outcome measures and 0 analyses. The primary outcome itself covers multiple cancer groups and proposes both monthly estimates and percentages, alongside a comparison with the HACM Study. The record does not report which outcomes were analyzed, how many statistical tests were performed, or whether any multiplicity strategy was used. No adjustment for multiple comparisons is reported in the registry record.

In general, examining many outcomes or groups can increase the chance that some apparent patterns arise by chance. Multiplicity procedures can address this concern when formal hypothesis tests are performed. For a descriptive study, transparent reporting of all planned groups and estimates can also help readers distinguish a broad descriptive survey from selective emphasis on particular findings. Neither the analysis results nor a prespecified reporting plan is available in the registry record, so the implications of multiple outcomes cannot be assessed.

Missing-data handling is not reported in the registry record. The record does not state how many participants had complete cancer classifications, whether quality-of-life surveys were completed, or how missing covariates or follow-up information were treated. It also does not report imputation, complete-case analysis, sensitivity analyses, or assumptions about missingness.

Analysis populations are not reported in the registry record. Although enrollment is listed as 460, the record does not specify whether all enrolled participants were included in every outcome analysis, how eligibility for the secondary trial-enrollment outcome was determined, or whether any participants were excluded. The registry record also does not describe whether the participant, cancer case, site, or month was the unit of analysis for each reported measure. These omissions limit assessment of denominators and interpretation of any future estimates.

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

The record establishes the study’s descriptive aim: to characterize cancer cases and patient characteristics among PWH presenting for care at domestic AMC sites. It also identifies groups of cancers and a proposed comparison with the HACM Study. These design details explain what the investigators intended to measure; they do not establish the cancer burden observed at the sites.

The posted registry record does not report primary outcome results. It therefore does not show the number of cases in each group, the monthly estimates, the cancer-type percentages, or how those percentages compare with HACM. It also does not report the result for the secondary outcome on successful enrollment of participants eligible for AMC trials, or findings from optional quality-of-life surveys. No inference about the direction or size of any pattern can be made from the study description alone.

Even if descriptive results were available, a study of participants presenting at participating AMC sites would characterize that observed care setting. It would not automatically represent all PWH, all people with cancer and HIV, or all cancer care in the United States. The registry record does not report enough detail about site participation, case ascertainment, or participant characteristics to assess representativeness.

The observational design also does not compare assigned treatments. The clinical-status groups describe differing circumstances, and allocation is not stated. Results from such groups would not by themselves establish that a treatment caused an outcome or that a particular patient characteristic caused trial participation or nonparticipation. No medical conclusion about treatment benefit or harm follows from the information reported in the registry record.

Accordingly, the principal meaning of the posted record is that a completed study was registered with a stated descriptive purpose and enrollment of 460, while the numerical findings needed to evaluate that purpose are not reported in the registry record.

12. Why This Trial Matters Statistically

This study addresses a statistical distinction that matters in clinical research: describing who reaches participating cancer-care sites is different from estimating a treatment effect. The stated primary outcome is a count and distribution of cancer cases among PWH presenting for care at domestic AMC sites. Those measures can help characterize the cases encountered by a clinical network, provided their definitions and denominators are clear.

The planned comparison with the HACM Study also highlights the challenges of comparing distributions across data sources. Differences may reflect real variation, but they may also arise from differences in who is captured, how cancer groups are defined, or what period is covered. Careful interpretation requires enough methodological detail to understand whether the sources are comparable. That detail and the comparison results are not reported in the registry record.

The study also describes interest in trial participation and optional quality-of-life surveys. These are important descriptive topics because enrollment and participant experience may shape which populations are represented in clinical research. The registry record lists a secondary outcome on successful enrollment among people eligible for AMC trials, but does not report its estimate or analysis methods. It therefore states a relevant question without providing statistical evidence to answer it.

For statistical readers, the record illustrates the difference between a registered aim, a completed study status, and posted results. Enrollment of 460 and completion status do not substitute for outcome estimates, denominators, or measures of precision. The absence of analysis results limits evaluation of the study’s descriptive aims and the generalizability of any conclusions. Complete outcome reporting would be needed to assess the observed cancer distribution and the uncertainty around it.

13. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The main limitation for interpreting this trial record is that no primary or secondary outcome results are reported. There are no cancer-group counts, monthly estimates, distribution percentages, comparison results, or analysis estimates for the secondary trial-enrollment outcome. The record lists 0 analyses, so the intended descriptive questions cannot be evaluated from the posted results.

The registry record provides limited detail on how the screening tool identified cases, how cancer groups were defined, or how new, existing, recurrent, and prior cancers were handled. It does not explain how participants with multiple cancers were counted, whether groups could overlap, or how missing classifications were managed. These details matter for both the numerators and denominators of counts and percentages.

The comparison with the HACM Study is described, but methods for aligning populations, cancer definitions, and observation periods are not reported. The record also does not describe site participation or the extent to which AMC cases represent cancer care among PWH outside the participating sites. Consequently, the intended external comparison and the broader representativeness of the study cannot be assessed.

Further limitations include the absence of a reported statistical analysis plan, analysis populations, missing-data procedures, precision estimates, and details of any adjustment for multiple outcomes. The enrollment figure of 460 does not establish how many participants contributed to each measure. The record describes optional quality-of-life surveys but does not report response or completion information. These are limitations of the information available in the registry record; they do not establish that the study did or did not address these issues in other documentation.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: Use of a Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the AMC — NCT05510908.
• Registry record last updated 2026-11-05; status last verified 2026-10.
• Results first posted 2026-03-25.
• 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

NCT05510908 is a completed, non-interventional study sponsored by the AIDS Malignancy Consortium. The registry record lists enrollment of 460, a start date of 2023-07-25, and primary completion on 2025-02-28. Its primary aim is to describe cancer counts and distributions among PWH presenting for care at domestic AMC sites, with a proposed comparison to the HACM Study. Optional quality-of-life surveys and a secondary outcome on successful enrollment among participants eligible for AMC trials are also described.

The registry record lists 11 outcome measures and 0 analyses. It does not report primary or secondary outcome estimates, statistical methods, analysis populations, or uncertainty measures. The record therefore supports description of the study’s aims and design, but not conclusions about the observed cancer burden, cancer-type distribution, trial enrollment, or participant-reported quality of life.