DiagnosticNCT06111963
Role of Inflammatory Markers in Sepsis
An observational study of Diagnostic, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diagnostic
- What is being tested?
- Serology tests
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 25 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Postoperative patients
Who may be able to join
- Cancer patients admitted to the surgical ICU following cancer related surgeries and diagnosed with sepsis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Diagnostic
- Being tested
- Serology tests
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serology testsDiagnostic test
CD4, CD25, IL17
| Study group | Role | What they receive |
|---|---|---|
| Septic patients | Not described Receives: Diagnostic Test: Serology tests | |
| Non Septic patients | Not described Receives: Diagnostic Test: Serology tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the expression CD4
Serology
Measured: 7 days
To evaluate the expression CD25
Serology
Measured: 7 days
To evaluate the expression IL17
Serology
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start1 Nov 2023
- Primary completion5 Jan 2025
- Study completion25 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiagnosticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Youssef Elsabeeny, National Cancer Institute, Egypt
- Investigators
- Walaa Y Elsabeeny, MD, Principal investigator, National Cancer Institute, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111963
- Sponsor's protocol ID
- AP2305-301-001
- Status last verified
- Jul 2025
- First submitted
- 16 Oct 2023
- Last updated
- 16 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Inflammatory Markers Measured Using Flow Cytometry in the Diagnosis and Prognosis of Sepsis in Surgical Cancer Patients
- ClinicalTrials.gov ID
- NCT06111963
- Acronym / sponsor ID
- AP2305-301-001
- Conditions
- Diagnostic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 5 Jan 2025 (actual)
- Study completion
- 25 Jan 2025 (actual)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Septic patients | – | Diagnostic Test: Serology tests |
| Non Septic patients | – | Diagnostic Test: Serology tests |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postoperative patients
Key inclusion criteria (1 listed)
- Cancer patients admitted to the surgical ICU following cancer related surgeries and diagnosed with sepsis
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serology testsCD4, CD25, IL17 | Diagnostic test | Non Septic patients, Septic patients |
Primary outcome
To evaluate the expression CD4
Time frame: 7 days
Serology
To evaluate the expression CD25
Time frame: 7 days
Serology
To evaluate the expression IL17
Time frame: 7 days
Serology
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walaa Y Elsabeeny, MD principal investigator
National Cancer Institute, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnostic, run by National Cancer Institute, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the expression CD4 (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.