Acute Myeloid Leukemia, De Novo Acute Myeloid Leukemia With Multilineage Dysplasia, Non-M3 Acute Myeloid Leukemia
Conditions
Keywords
Acute myeloid leukemia, C-reactive protein to albumin ratio
Brief summary
This prospective cohort study aims to evaluate the prognostic significance of the C-reactive protein-to-albumin ratio (CAR), albumin-to-fibrinogen ratio (AFR), and serum ferritin level in newly diagnosed de novo non-M3 acute myeloid leukemia patients at Assiut University Hospitals.
Detailed description
Acute myeloid leukemia (AML) is an aggressive hematological malignancy with poor clinical outcomes. Inflammatory and nutritional biomarkers such as the C-reactive protein-to-albumin ratio (CAR), albumin-to-fibrinogen ratio (AFR), and serum ferritin have shown potential prognostic value in various malignancies. This prospective single-center cohort study will include newly diagnosed de novo non-M3 AML patients aged 18 to 65 years. Baseline laboratory parameters including CRP, albumin, fibrinogen, and ferritin will be measured before induction chemotherapy. Patients will be followed for overall survival, event-free survival, and response to induction therapy. The study will assess the association of CAR, AFR, and serum ferritin with clinical outcomes.
Interventions
None listed
Sponsors
Assiut University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 65 years * Newly diagnosed de novo non-M3 acute myeloid leukemia * Both sexes * Willingness to provide informed consent
Exclusion criteria
* \- Patient refusal * Significant cardiac, hepatic, or renal disease * Diabetes mellitus with polyneuropathy * Severe organ dysfunction (modified Marshall score ≥ 2) * History of MDS transformed to AML * Previous blood transfusions * Relapsed AML * Previous exposure to chemotherapy or radiotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | Up to 24 months | Time from the date of AML diagnosis to death from any cause or last follow-up for surviving patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete remission rate after induction chemotherapy | Day 28 after induction chemotherapy | Proportion of patients achieving complete remission after induction chemotherapy, defined as bone marrow blasts less than 5%, absolute neutrophil count greater than 1.0 × 10⁹/L, platelet count greater than 100 × 10⁹/L, and independence from red cell transfusions. |
| Event-free survival | Up to 24 months | Time from diagnosis to the first occurrence of treatment failure, relapse, or death from any cause. |
| Prognostic value of C-reactive protein-to-albumin ratio (CAR) | Baseline and up to 24 months | Hazard ratio for overall survival and event-free survival according to baseline C-reactive protein-to-albumin ratio (CAR), calculated as CRP (mg/L) divided by serum albumin (g/L), using Cox proportional hazards regression. |
| Prognostic value of albumin-to-fibrinogen ratio (AFR) | Baseline and up to 24 months | Hazard ratio for overall survival and event-free survival according to baseline albumin-to-fibrinogen ratio (AFR), calculated as plasma fibrinogen concentration (g/L) divided by serum albumin concentration (g/L), using Cox proportional hazards regression. |
| Prognostic value of serum ferritin | Baseline and up to 24 months | Hazard ratio for overall survival and event-free survival according to baseline serum ferritin level (ng/mL, corrected if CRP is elevated), using Cox proportional hazards regression. |
Contacts
CONTACTAya s Noureldin, Resident
STUDY_CHAIRMohamed R Hameed, prof
Internal medicine, clinical Hematology & bone marrow tramsplant unit
Outcome results
None listed