- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06111963
Role of Inflammatory Markers in Sepsis
July 11, 2025 updated by: Walaa Youssef Elsabeeny, National Cancer Institute, Egypt
Role of Inflammatory Markers Measured Using Flow Cytometry in the Diagnosis and Prognosis of Sepsis in Surgical Cancer Patients
A diagnostic and prognostic study, in which the expression of CD64 in activated neutrophils and CD64 and IL17A regulatory T cells in patients with sepsis will be evaluated as a probable marker for sepsis as a primary objective
Study Overview
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt, 11796
- Walaa Y Elsabeeny
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Postoperative patients
Description
Inclusion Criteria:
- Cancer patients admitted to the surgical ICU following cancer related surgeries and diagnosed with sepsis
Exclusion Criteria:
- Refusal of patient or patient guardian to participate.
- Intraoperative massive blood loss and massive blood transfusion
- Patients with impaired preoperative kidney or liver function tests
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Septic patients
|
CD4, CD25, IL17
|
|
Non Septic patients
|
CD4, CD25, IL17
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To evaluate the expression CD4
Time Frame: 7 days
|
Serology
|
7 days
|
|
To evaluate the expression CD25
Time Frame: 7 days
|
Serology
|
7 days
|
|
To evaluate the expression IL17
Time Frame: 7 days
|
Serology
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Walaa Y Elsabeeny, MD, National Cancer Institute, Cairo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2023
Primary Completion (Actual)
January 5, 2025
Study Completion (Actual)
January 25, 2025
Study Registration Dates
First Submitted
October 16, 2023
First Submitted That Met QC Criteria
October 26, 2023
First Posted (Actual)
November 1, 2023
Study Record Updates
Last Update Posted (Actual)
July 16, 2025
Last Update Submitted That Met QC Criteria
July 11, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AP2305-301-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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