LeukemiaNCT07898488
Glycemic Control in Leukemia Patients
An observational study of Leukemia, run by Assiut University.
Trial summary
Glycemic control in leukemia patients Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Leukemia
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 12 Dec 2026to 12 Dec 2029
- How long will I take part?
- 8 Months
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Newly diagnosed adult patients (aged 18 years or older) with histologically/cytologically confirmed leukemia (including Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia, or Chronic Lymphocytic Leukemia) presenting to the Clinical Hematology \& Medical Oncology Unit at Assiut University Hospital prior to starting baseline induction chemotherapy.
Who may be able to join
- Age ≥ 18 years. Newly diagnosed, histologically/cytologically confirmed adult leukemia patients (AML, ALL, CML, or CLL) before starting definitive induction therapy.
- Provision of written informed consent.
Who cannot join
- Recent blood transfusion within the preceding 3 months before baseline glycemic assessment.
- Active severe co-existing acute infection or sepsis independent of leukemia diagnosis.
- Known pre-existing active secondary malignancy. Pregnancy or lactation. History of severe hemoglobinopathies (e.g., sickle cell anemia, thalassemia major) that significantly alter erythrocyte lifespan independent of disease.
- Incomplete clinical data or loss to follow-up.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prognostic Significance of Combined Red Cell Distribution Width and Glycated Hemoglobin / Hemoglobin Glycation Index in Leukemia: A Prospective Study.
Glycemic control in leukemia patients
Read the detailed description
Hematological malignancies, particularly leukemia, exhibit complex systemic interactions involving tumor-induced inflammation and metabolic dysregulation. Red Cell Distribution Width (RDW) reflects anisocytosis and is an established biomarker of systemic inflammation, impaired erythropoiesis, and oxidative stress. Elevated pretreatment RDW strongly correlates with adverse survival outcomes across various blood cancers. Concurrently, glycemic metrics such as Glycated Hemoglobin (HbA1c) and Hemoglobin Glycation Index (HGI)-which measures the discrepancy between measured HbA1c and glucose-predicted HbA1c-quantify metabolic dysfunction. A high HGI indicates an altered glycemic environment supporting tumor growth and aggressive disease behavior.
However, raw HbA1c values in leukemia patients are frequently confounded by frequent blood transfusions, disease-related anemia, chemotherapy, and altered erythrocyte lifespan. Evaluating HGI circumvents these confounding artifacts, providing a reliable measure of true metabolic dysregulation. Combining RDW with HGI captures the dual pathophysiological drivers of chronic inflammation and metabolic subversion. This prospective study aims to evaluate the combined prognostic significance of baseline RDW and HGI in predicting survival, disease progression, and overall mortality risk in leukemia patients, establishing an accessible personalized risk stratification model.
- Conditions
- Leukemia
- Medical subject headings
- Leukemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Time from initial diagnostic blood sampling/enrollment to death from any cause or date of last follow-up
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start12 Dec 2026 (estimated)
- Primary completion12 Dec 2028 (estimated)
- Study completion12 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (estimated)
- Target duration
- 8 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Amir Thabet Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898488
- Sponsor's protocol ID
- Leukemia patients
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 27 Oct 2026
- 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Significance of Combined Red Cell Distribution Width and Glycated Hemoglobin / Hemoglobin Glycation Index in Leukemia: A Prospective Study.
- ClinicalTrials.gov ID
- NCT07898488
- Acronym / sponsor ID
- Leukemia patients
- Conditions
- Leukemia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 12 Dec 2026 (estimated)
- Primary completion
- 12 Dec 2028 (estimated)
- Study completion
- 12 Dec 2029 (estimated)
- First posted
- 27 Oct 2026 (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.
Glycemic control in leukemia patients
Detailed description
Hematological malignancies, particularly leukemia, exhibit complex systemic interactions involving tumor-induced inflammation and metabolic dysregulation. Red Cell Distribution Width (RDW) reflects anisocytosis and is an established biomarker of systemic inflammation, impaired erythropoiesis, and oxidative stress. Elevated pretreatment RDW strongly correlates with adverse survival outcomes across various blood cancers. Concurrently, glycemic metrics such as Glycated Hemoglobin (HbA1c) and Hemoglobin Glycation Index (HGI)-which measures the discrepancy between measured HbA1c and glucose-predicted HbA1c-quantify metabolic dysfunction. A high HGI indicates an altered glycemic environment supporting tumor growth and aggressive disease behavior.
However, raw HbA1c values in leukemia patients are frequently confounded by frequent blood transfusions, disease-related anemia, chemotherapy, and altered erythrocyte lifespan. Evaluating HGI circumvents these confounding artifacts, providing a reliable measure of true metabolic dysregulation. Combining RDW with HGI captures the dual pathophysiological drivers of chronic inflammation and metabolic subversion. This prospective study aims to evaluate the combined prognostic significance of baseline RDW and HGI in predicting survival, disease progression, and overall mortality risk in leukemia patients, establishing an accessible personalized risk stratification model.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Months
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Newly diagnosed adult patients (aged 18 years or older) with histologically/cytologically confirmed leukemia (including Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia, or Chronic Lymphocytic Leukemia) presenting to the Clinical Hematology \& Medical Oncology Unit at Assiut University Hospital prior to starting baseline induction chemotherapy.
Key inclusion criteria (2 listed)
- Age ≥ 18 years. Newly diagnosed, histologically/cytologically confirmed adult leukemia patients (AML, ALL, CML, or CLL) before starting definitive induction therapy.
- Provision of written informed consent.
Key exclusion criteria (4 listed)
- Recent blood transfusion within the preceding 3 months before baseline glycemic assessment.
- Active severe co-existing acute infection or sepsis independent of leukemia diagnosis.
- Known pre-existing active secondary malignancy. Pregnancy or lactation. History of severe hemoglobinopathies (e.g., sickle cell anemia, thalassemia major) that significantly alter erythrocyte lifespan independent of disease.
- Incomplete clinical data or loss to follow-up.
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
Overall Survival (OS)
Time frame: Up to 24 months
Time from initial diagnostic blood sampling/enrollment to death from any cause or date of last follow-up
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 27 Oct 2026.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 2 inclusion and 4 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 27 Oct 2026. 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?
Contact Ahmed Amir Thabet, Master (0882660113, amyr34592@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Up to 24 months). 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 27 Oct 2026.