Assessment of Antithrombin III, Protein C, Protein S and D-dimer in Acute Leukemia
1 other identifier
observational
90
1 country
1
Brief 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)). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2023
CompletedFirst Submitted
Initial submission to the registry
June 17, 2025
CompletedFirst Posted
Study publicly available on registry
June 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedJanuary 29, 2026
January 1, 2026
2.3 years
June 17, 2025
January 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
at the time of patient recruitment for the study.
Study Arms (3)
acute lymphoblastic leukemia
patients diagnosed with acute lymphoblastic leukemia.
acute myeloid leukemia
patients diagnosed with acute myeloid leukemia.
control group
controlled group include healthy persons not suffering from acute leukemia either clinically or laboratory
Interventions
quantitative measurement( ug/ml)
Flow cytometry immunophenotyping
quantitative measurement(%)
quantitative measurement(%)
quantitative measurement(%)
Eligibility Criteria
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.
You may qualify if:
- patients with leukemia in group 1 and 2.
- willing to participate in the study.
You may not qualify if:
- refusing to participate.
- patients with know to have either hereditary thrombophilia or current thrombosis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Al-Hussein University Hospital
Cairo, 11633, Egypt
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- lecturer and consultant at Obstetrics and Gynecology Department.
Study Record Dates
First Submitted
June 17, 2025
First Posted
June 25, 2025
Study Start
June 1, 2023
Primary Completion
October 1, 2025
Study Completion
October 1, 2025
Last Updated
January 29, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- The de-identified IPD will become available for access upon publication of the study's main results. The dataset will remain accessible for a period of ten (10) years following the initial publication date.
- Access Criteria
- Access to the IPD will be granted to qualified researchers for legitimate scientific purposes, subject to the following criteria: Submission of a detailed research proposal outlining the scientific objectives, methodology for analysis, and a commitment to ethical research practices. Approval of the research proposal by a designated Data Access Committee or institutional review board, if applicable, to ensure scientific merit and ethical considerations. Execution of a formal Data Use Agreement (DUA) with the study principal investigators, specifying the terms of data usage, confidentiality, data security, and a strict prohibition against any attempt at re-identification of participants. Agreement to acknowledge the original study and its investigators in any resulting publications or presentations. Confirmation that the proposed research aligns with the informed consent provided by study participants.
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.