ClinicalTrials.gg
Not yet recruitingNCT07898488Updated Oct 27, 2026

Glycemic Control in Leukemia Patients

An observational study in Leukemia, sponsored by Assiut University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Assiut University · Observational

Updated Oct 27, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
54
Sex
All
01

Study summary

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.

02

Conditions studied

  • Leukemia

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03

In context

Leukemia

2,381 studies on the registry are indexed under Leukemia; 253 are open to participants now.

This study's planned enrollment of 54 is below the median of 142 across 332 observational studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 18 years. Newly diagnosed, histologically/ confirmed adult leukemia patients (AML, ALL, CML, or CLL) before starting definitive induction therapy.

Provision of written .

Exclusion criteria

Exclusion Criteria:

  • 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 . 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.

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
54 participants (estimated)
Target follow-up
8 Months
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Overall Survival (OS)

    Time from initial diagnostic blood sampling/enrollment to death from any cause or date of last follow-up

    Time frame: Up to 24 months

07

Study locations

No study locations are listed for this record.

08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Dec 2028, 24 months later.

Of 96 non-industry observational studies under Leukemia, half reached primary completion within 119 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 269. This study's planned 24 months is below that.

Counting every sponsor, half of 110 studies reached it within 119 months; a quarter within 40 and three quarters within 269.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 21, 2026
First posted
Oct 27, 2026
StartEst.
Dec 12, 2026
Primary completionEst.
Dec 12, 2028
CompletionEst.
Dec 12, 2029
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07898488
Lead sponsor
Assiut University
Responsible party
Ahmed Amir Thabet Ahmed (Assistant Lecturer, Assiut University) — Principal investigator
First posted
Oct 27, 2026
Start date
Dec 12, 2026 (estimated)
Primary completion
Dec 12, 2028 (estimated)
Completion
Dec 12, 2029 (estimated)
Last update
Oct 27, 2026

Study contacts

Ahmed Amir Thabet, Master
Contact
amyr34592@gmail.com
0882660113
Wala Anwer Mohamed, Prof
Contact
Walaaanwer@aun.edu.eg
+2 01111677728

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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