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NCT Number: NCT07795502

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sohag Oncology Center

Sohag, Sohag Governorate, Egypt

Location status: Recruiting

Location contact

Esraa Mohamed Abdelraheem, Demonstrator

CONTACT

[email protected]

0201097937788

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed diagnosis of a solid or hematological malignancy.
  • Clinical suspicion of sepsis according to treating physicians.
  • At least one blood culture obtained before or shortly after initiation of antimicrobial therapy.
  • Availability for clinical follow-up during hospitalization.

Exclusion criteria

  • Patients receive palliative care only.
  • Absence of blood culture sampling.
  • Incomplete clinical or laboratory data.
  • Refusal to participate in the study, when applicable.

Treatment and study plan

Primary outcomes

  1. 30-day all-cause mortality

    Time frame: Within 30 days after enrollment

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Dynamic Infection Kinetics as an Early Diagnostic and Monitoring Tool for Sepsis in Oncology Patients

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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