Acute Myeloid LeukemiaNCT07115537
The Prognostic Significance of Platelet to White Blood Cell Ratio (PWR) in Patients With Acute Myeloid Leukemia
An observational study of Acute Myeloid Leukemia, run by Assiut University.
Trial summary
Acute Myeloid Leukemia (AML) is a malignant hematological disease characterized by clonal proliferation of myeloid precursors with a reduced capacity for differentiation. It leads to accumulation of immature blasts in bone marrow (BM), peripheral blood (PB), and other tissues (Döhner et al. 2017). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Acute Myeloid Leukemia
Who may be able to join
- age >18 years
- both sex
- Patients with Acute Myeloid Leukemia
Who cannot join
- patients with other hematological diseases
About this study
Acute Myeloid Leukemia (AML) is a malignant hematological disease characterized by clonal proliferation of myeloid precursors with a reduced capacity for differentiation. It leads to accumulation of immature blasts in bone marrow (BM), peripheral blood (PB), and other tissues (Döhner et al. 2017). AML is the most common type of acute leukemia in adults, with an incidence of approximately 4 cases per 100,000 individuals per year. It predominantly affects older adults with a median age at diagnosis of 68 years (Siegel et al. 2023).
The etiology of AML is complex and multifactorial, involving genetic mutations, chromosomal abnormalities, environmental exposures, and pre-existing hematological conditions such as myelodysplastic syndromes (MDS) (Papaemmanuil et al. 2016). Advances in genomic profiling have revealed that mutations in genes such as FLT3, NPM1, IDH1/2, and TP53 play a critical role in the pathogenesis and prognosis of AML (Döhner et al. 2022).
In recent years, there has been a growing interest in using systemic inflammatory markers derived from complete blood counts (CBC) as valuable and cost-effective prognostic indicators. Ratios such as the neutrophil-to-lymphocyte ratio (NLR), plateletto- lymphocyte ratio (PLR), and lymphocyte-to-monocyte ratio (LMR have shown prognostic value in various cancers, including AML (Zhang et al. 2021). Platelets have been recognized not only for their hemostatic role but also for their involvement in tumor biology, immune modulation, and inflammation. Conversely, elevated white blood cell (WBC) counts in AML often represent a high leukemic burden and are associated with worse clinical outcomes (Döhner et al. 2015; Arber et al. 2016).
- Conditions
- Acute Myeloid Leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study group | patients with Acute Myeloid Leukemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of Platelet to White Blood Cell Ratio (PWR)
The accuracy of Prognostic Significance of Platelet to White Blood Cell Ratio (PWR) in Patients with Acute Myeloid Leukemia
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaymaa Abd El-Wahab El-Sadek, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115537
- Sponsor's protocol ID
- PWR Acute Myeloid Leukemia
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Significance of Platelet to White Blood Cell Ratio (PWR) in Patients With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT07115537
- Acronym / sponsor ID
- PWR Acute Myeloid Leukemia
- Conditions
- Acute Myeloid Leukemia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 11 Aug 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.
Acute Myeloid Leukemia (AML) is a malignant hematological disease characterized by clonal proliferation of myeloid precursors with a reduced capacity for differentiation. It leads to accumulation of immature blasts in bone marrow (BM), peripheral blood (PB), and other tissues (Döhner et al. 2017). AML is the most common type of acute leukemia in adults, with an incidence of approximately 4 cases per 100,000 individuals per year. It predominantly affects older adults with a median age at diagnosis of 68 years (Siegel et al. 2023).
The etiology of AML is complex and multifactorial, involving genetic mutations, chromosomal abnormalities, environmental exposures, and pre-existing hematological conditions such as myelodysplastic syndromes (MDS) (Papaemmanuil et al. 2016). Advances in genomic profiling have revealed that mutations in genes such as FLT3, NPM1, IDH1/2, and TP53 play a critical role in the pathogenesis and prognosis of AML (Döhner et al. 2022).
In recent years, there has been a growing interest in using systemic inflammatory markers derived from complete blood counts (CBC) as valuable and cost-effective prognostic indicators. Ratios such as the neutrophil-to-lymphocyte ratio (NLR), plateletto- lymphocyte ratio (PLR), and lymphocyte-to-monocyte ratio (LMR have shown prognostic value in various cancers, including AML (Zhang et al. 2021). Platelets have been recognized not only for their hemostatic role but also for their involvement in tumor biology, immune modulation, and inflammation. Conversely, elevated white blood cell (WBC) counts in AML often represent a high leukemic burden and are associated with worse clinical outcomes (Döhner et al. 2015; Arber et al. 2016).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | –patients with Acute Myeloid Leukemia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Acute Myeloid Leukemia
Key inclusion criteria (3 listed)
- age >18 years
- both sex
- Patients with Acute Myeloid Leukemia
Key exclusion criteria (1 listed)
- patients with other hematological diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
accuracy of Platelet to White Blood Cell Ratio (PWR)
Time frame: baseline
The accuracy of Prognostic Significance of Platelet to White Blood Cell Ratio (PWR) in Patients with Acute Myeloid Leukemia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
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ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, run by Assiut University.
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 3 inclusion and 1 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: opening soon, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
accuracy of Platelet to White Blood Cell Ratio (PWR) (time frame: baseline). 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 11 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.