NCT06111963

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2025

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2025

Completed
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

1.2 years

First QC Date

October 16, 2023

Last Update Submit

July 11, 2025

Conditions

Diagnostic

Outcome Measures

Primary Outcomes (3)

  • To evaluate the expression CD4

    Serology

    7 days

  • To evaluate the expression CD25

    Serology

    7 days

  • To evaluate the expression IL17

    Serology

    7 days

Study Arms (2)

Septic patients

Diagnostic Test: Serology tests

Non Septic patients

Diagnostic Test: Serology tests

Interventions

Serology testsDIAGNOSTIC_TEST

CD4, CD25, IL17

Non Septic patientsSeptic patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Postoperative patients

You may qualify if:

  • Cancer patients admitted to the surgical ICU following cancer related surgeries and diagnosed with sepsis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walaa Y Elsabeeny

Cairo, 11796, Egypt

Location

MeSH Terms

Conditions

Disease

Interventions

Serologic Tests

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic Techniques

Study Officials

  • Walaa Y Elsabeeny, MD

    National Cancer Institute, Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesia and Pain management

Study Record Dates

First Submitted

October 16, 2023

First Posted

November 1, 2023

Study Start

November 1, 2023

Primary Completion

January 5, 2025

Study Completion

January 25, 2025

Last Updated

July 16, 2025

Record last verified: 2025-07

Locations

EG(1)