Sepsis · Observational Study

Dynamic Infection Kinetics for Early Diagnosis, Monitoring, and Prognostication of Sepsis in Adult Oncology Patients: Evaluating Serial Infection Biomarkers, Blood Culture Kinetics, Treatment Response, Disease Severity, and Clinical Outcomes

ClinicalTrials.gov · September 1, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registry record for a planned observational cohort study that is currently recruiting. It describes an intention to evaluate serial infection biomarkers and blood culture kinetics as early diagnostic and monitoring tools for sepsis in adult oncology patients, with 30-day mortality as the primary outcome. No results are yet available.

What was studied

Observational. Sepsis; age from 18 Years. Intervention: Oncology Patients with Suspected Sepsis. n = 100. 1 site: Egypt.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a prospective observational cohort study still in recruitment with no results posted; it aims to evaluate biomarker kinetics for sepsis diagnosis and prognosis in oncology patients but reports only planned enrollment and outcomes, not findings.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measure: 30-day all-cause mortality (assessed at Within 30 days after enrollment)

DesignObservational

PopulationSepsis; age from 18 Years

Sample size100

InterventionOncology Patients with Suspected Sepsis

Setting1 site: Egypt

Reported figures

Quoted from the source exactly as published.

Planned enrollment100

Primary outcome measure30-day all-cause mortality

Follow-up durationUp to 30 days after enrollment, during hospitalization

Caveats

This is a registry entry only; no results have been posted or peer-reviewed.
Study is actively recruiting and not yet complete.
No effect sizes, p-values, or outcome data are reported.
Observational design without comparator limits causal inference regarding biomarker utility.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Prospective observational cohort; no control arm or randomization.

Directness

strong

Studies real patients with suspected sepsis using clinically relevant biomarkers and mortality.

Consistency

insufficient

No results reported; consistency cannot be assessed.

Risk of bias

insufficient

No results available; bias assessment deferred pending completion and analysis.

Sample adequacy

limited

Planned enrollment 100 participants; modest size for multivariate biomarker analysis.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07795502). This is a study registration, not published results. Lead sponsor: Sohag University. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 100 participants (ESTIMATED). Conditions: Sepsis. Primary outcome measures: 30-day all-cause mortality , Within 30 days after enrollment. Brief summary: Dynamic Infection Kinetics as an Early Diagnostic and Monitoring Tool for Sepsis in Oncology Patients This study aims to evaluate whether changes over time in infection-related biomarkers and blood culture findings can help detect sepsis earlier and monitor the response to treatment in adult patients with cancer. Cancer patients are at increased risk of developing serious infections and sepsis because of their underlying disease and its treatment. Early diagnosis and monitoring can be challenging because the signs and laboratory findings of infection may be nonspecific. This prospective observational cohort study will include adult oncology patients with suspected sepsis who have at least one blood culture collected as part of their routine medical care. Clinical, laboratory, and microbiological information will be collected, including blood culture results, causative microorganisms, time to blood culture positivity, blood culture clearance time, C-reactive protein (CRP), procalcitonin (PCT), presepsin, absolute neutrophil count, serum lactate, and clinical severity measures. Patients will be followed during hospitalization and for up to 30 days after enrollment. The study will assess whether changes in these markers over time are associated with treatment response, persistent infection, complications, intensive care admission, and mortality. The findings may help identify patients at higher risk of poor outcomes and may contribute to improved monitoring and management of sepsis in patients with cancer.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Sohag UniversityNCT07795502Sepsis