Acute LeukemiaNCT07036809
Assessment of Antithrombin III, Protein C, Protein S and D-dimer in Acute Leukemia
An observational study of Acute Leukemia, run by Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy at 1 site in Egypt.
Trial summary
The goal of this observational study is to evaluate the levels of Antithrombin III, Protein C, Protein S, and D-dimer in patients with Acute Leukemia (Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML)). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Acute Leukemia
- What is being tested?
- Antithrombin III, Protein C and Protein S
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 1 Oct 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This study will include 90 subjects, without regard to their sex or age. The subjects will be classified into two main groups: a patient group and a control group. Patient Group (Group 1): This group will consist of 60 patients suffering from acute leukemia. It is further divided into two subgroups: Group 1A: 30 patients diagnosed with acute lymphoblastic leukemia (ALL). Group 1B: 30 patients diagnosed with acute myeloid leukemia (AML). Patients will be selected from the outpatient clinic, internal medicine, and oncology departments at both Al Hussein and Sayed Galal University Hospitals, provided they give appropriate consent to participate. Control Group (Group 2): This group will consist of 30 healthy individuals who are not suffering from acute leukemia, as determined both clinically and through laboratory tests.
Who may be able to join
- patients with leukemia in group 1 and 2.
- willing to participate in the study.
Who cannot join
- refusing to participate.
- patients with know to have either hereditary thrombophilia or current thrombosis.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to evaluate the levels of Antithrombin III, Protein C, Protein S, and D-dimer in patients with Acute Leukemia (Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML)). The main questions it aims to answer are:
What are the levels of Antithrombin III, Protein C, Protein S, and D-dimer in patients with Acute Lymphoblastic Leukemia? What are the levels of Antithrombin III, Protein C, Protein S, and D-dimer in patients with Acute Myeloid Leukemia? Researchers will compare patients with Acute Leukemia (30 with ALL and 30 with AML) to 30 healthy control subjects to see if there are significant differences in the levels of Antithrombin III, Protein C, Protein S, and D-dimer.
Read more
Participants will:
Undergo full history and clinical examination. Have routine hematological analysis including Complete Blood Count (CBC), blood film, Erythrocyte sedimentation rate (ESR), Prothrombin Time Test and INR (PT/INR), and partial thromboplastin time (PTT).
Have specific tests for quantitative measurement of Antithrombin III, Protein C, Protein S, and D-dimer.
Undergo Flow cytometry immunophenotyping.
- Conditions
- Acute Leukemia
- Being tested
- Antithrombin III, Protein C, Protein S, D-dimer, Flow cytometry immunophenotyping
- Keywords
- acute leukemia, Antithrombin III, protein C, Protein S, D Dimer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antithrombin IIIDiagnostic test
quantitative measurement(%)
Protein CDiagnostic test
quantitative measurement(%)
Protein SDiagnostic test
quantitative measurement(%)
D-dimerDiagnostic test
quantitative measurement( ug/ml)
Flow cytometry immunophenotypingDiagnostic test
Flow cytometry immunophenotyping
| Study group | Role | What they receive |
|---|---|---|
| acute lymphoblastic leukemia | patients diagnosed with acute lymphoblastic leukemia. Receives: Diagnostic Test: Antithrombin III; Diagnostic Test: Protein C; Diagnostic Test: Protein S; Diagnostic Test: D-dimer; Diagnostic Test: Flow cytometry immunophenotyping | |
| acute myeloid leukemia | patients diagnosed with acute myeloid leukemia. Receives: Diagnostic Test: Antithrombin III; Diagnostic Test: Protein C; Diagnostic Test: Protein S; Diagnostic Test: D-dimer; Diagnostic Test: Flow cytometry immunophenotyping | |
| control group | controlled group include healthy persons not suffering from acute leukemia either clinically or laboratory Receives: Diagnostic Test: Antithrombin III; Diagnostic Test: Protein C; Diagnostic Test: Protein S; Diagnostic Test: D-dimer; Diagnostic Test: Flow cytometry immunophenotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Antithrombin III, Protein C, Protein S, and D-dimer Levels in Acute Leukemia Patients
To evaluate and compare the quantitative levels of Antithrombin III, Protein C, Protein S, and D-dimer in patients diagnosed with Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML) against healthy control subjects. This assessment will help determine any significant differences in these coagulation parameters within the different acute leukemia subtypes and in comparison to healthy individuals.
Measured: at the time of patient recruitment for the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start1 Jun 2023
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies 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
- Retrospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036809
- Sponsor's protocol ID
- clinicalpath1
- Status last verified
- Jan 2026
- First submitted
- 17 Jun 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant Data (IPD) from this study, including de-identified demographic information, clinical examination findings, routine hematological analysis results (Complete Blood Count, Erythrocyte Sedimentation Rate, Prothrombin Time/INR, partial thromboplastin time), and specific test results (Antithrombin III, Protein C, Protein S, D-dimer, and Flow cytometry immunophenotyping), will be made available. The data will be provided in a secure, anonymized format suitable for secondary analysis (e.g., CSV or statistical software file types). This sharing aims to foster further research, facilitate meta-analyses, and enable validation studies by the wider scientific community, while strictly safeguarding participant privacy.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Antithrombin III, Protein C, Protein S and D-dimer in Acute Leukemia
- ClinicalTrials.gov ID
- NCT07036809
- Acronym / sponsor ID
- clinicalpath1
- Conditions
- Acute Leukemia
- Keywords
- acute leukemia, Antithrombin III, protein C, Protein S, D Dimer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Muhamed Ahmed Abdelmoaty Muhamed AlhagrasyUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 25 Jun 2025 (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.
The goal of this observational study is to evaluate the levels of Antithrombin III, Protein C, Protein S, and D-dimer in patients with Acute Leukemia (Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML)). The main questions it aims to answer are:
What are the levels of Antithrombin III, Protein C, Protein S, and D-dimer in patients with Acute Lymphoblastic Leukemia? What are the levels of Antithrombin III, Protein C, Protein S, and D-dimer in patients with Acute Myeloid Leukemia? Researchers will compare patients with Acute Leukemia (30 with ALL and 30 with AML) to 30 healthy control subjects to see if there are significant differences in the levels of Antithrombin III, Protein C, Protein S, and D-dimer.
Participants will:
Undergo full history and clinical examination. Have routine hematological analysis including Complete Blood Count (CBC), blood film, Erythrocyte sedimentation rate (ESR), Prothrombin Time Test and INR (PT/INR), and partial thromboplastin time (PTT).
Have specific tests for quantitative measurement of Antithrombin III, Protein C, Protein S, and D-dimer.
Undergo Flow cytometry immunophenotyping.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| acute lymphoblastic leukemia | – | Diagnostic Test: Antithrombin III, Diagnostic Test: Protein C, Diagnostic Test: Protein S, Diagnostic Test: D-dimer, Diagnostic Test: Flow cytometry immunophenotypingpatients diagnosed with acute lymphoblastic leukemia. |
| acute myeloid leukemia | – | Diagnostic Test: Antithrombin III, Diagnostic Test: Protein C, Diagnostic Test: Protein S, Diagnostic Test: D-dimer, Diagnostic Test: Flow cytometry immunophenotypingpatients diagnosed with acute myeloid leukemia. |
| control group | – | Diagnostic Test: Antithrombin III, Diagnostic Test: Protein C, Diagnostic Test: Protein S, Diagnostic Test: D-dimer, Diagnostic Test: Flow cytometry immunophenotypingcontrolled group include healthy persons not suffering from acute leukemia either clinically or laboratory |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will include 90 subjects, without regard to their sex or age. The subjects will be classified into two main groups: a patient group and a control group. Patient Group (Group 1): This group will consist of 60 patients suffering from acute leukemia. It is further divided into two subgroups: Group 1A: 30 patients diagnosed with acute lymphoblastic leukemia (ALL). Group 1B: 30 patients diagnosed with acute myeloid leukemia (AML). Patients will be selected from the outpatient clinic, internal medicine, and oncology departments at both Al Hussein and Sayed Galal University Hospitals, provided they give appropriate consent to participate. Control Group (Group 2): This group will consist of 30 healthy individuals who are not suffering from acute leukemia, as determined both clinically and through laboratory tests.
Key inclusion criteria (2 listed)
- patients with leukemia in group 1 and 2.
- willing to participate in the study.
Key exclusion criteria (2 listed)
- refusing to participate.
- patients with know to have either hereditary thrombophilia or current thrombosis.
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 |
|---|---|---|
| Antithrombin IIIquantitative measurement(%) | Diagnostic test | acute lymphoblastic leukemia, acute myeloid leukemia, control group |
| Protein Cquantitative measurement(%) | Diagnostic test | acute lymphoblastic leukemia, acute myeloid leukemia, control group |
| Protein Squantitative measurement(%) | Diagnostic test | acute lymphoblastic leukemia, acute myeloid leukemia, control group |
| D-dimerquantitative measurement( ug/ml) | Diagnostic test | acute lymphoblastic leukemia, acute myeloid leukemia, control group |
| Flow cytometry immunophenotypingFlow cytometry immunophenotyping | Diagnostic test | acute lymphoblastic leukemia, acute myeloid leukemia, control group |
Primary outcome
Assessment of Antithrombin III, Protein C, Protein S, and D-dimer Levels in Acute Leukemia Patients
Time frame: at the time of patient recruitment for the study.
To evaluate and compare the quantitative levels of Antithrombin III, Protein C, Protein S, and D-dimer in patients diagnosed with Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML) against healthy control subjects. This assessment will help determine any significant differences in these coagulation parameters within the different acute leukemia subtypes and in comparison to healthy individuals.
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 29 Jan 2026.
- Individual participant dataSharing planned: Yes. Individual Participant Data (IPD) from this study, including de-identified demographic information, clinical examination findings, routine hematological analysis results (Complete Blood Count, Erythrocyte Sedimentation Rate, Prothrombin Time/INR, partial thromboplastin time), and specific test results (Antithrombin III, Protein C, Protein S, D-dimer, and Flow cytometry immunophenotyping), will be made available. The data will be provided in a secure, anonymized format suitable for secondary analysis (e.g., CSV or statistical software file types). This sharing aims to foster further research, facilitate meta-analyses, and enable validation studies by the wider scientific community, while strictly safeguarding participant privacy.
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RecruitingPhase 2
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Active, not recruitingPhase 2
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RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
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Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute Leukemia, run by Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy 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 2 inclusion and 2 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 29 Jan 2026. 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?
Assessment of Antithrombin III, Protein C, Protein S, and D-dimer Levels in Acute Leukemia Patients (time frame: at the time of patient recruitment for the study.). 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 29 Jan 2026.