The Prognostic Role of Fibrinogen to Albumin Ratio in Acute Leukemia Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 90
- Primary Endpoint
- The prognostic role of fibrinogen to albumin ratio in acute leukemia patients
Study Overview
Brief Summary
The study aim to investigate whether levels of acute phase reactants at diagnosis and after 6 months of follow-up correlate with survival and response to treatment in newly diagnosed acute leukemia.Ultimately, we will evaluate the fibrinogen/albumin ratio, a simple score based on acute phase protein levels, whether it can provide relevant prognostic information in acute leukemia patients at diagnosis and after 6 months of follow-up.
Detailed Description
Leukemia is a heterogeneous group of hematologic malignancies that arise from the dysfunctional proliferation of developing leukocytes. It is classified as either acute or chronic based on the rapidity of proliferation and as myelocytic or lymphocytic based on the cell of origin.(Chennamadhavuni et al., 2024) .
Acute myeloid leukemia (AML) is a disease of the bone marrow, a disorder of hematopoietic stem cells due to genetic alterations in blood cell precursors resulting in overproduction of neoplastic clonal myeloid stem cells.(Grimwade D HB, Ivey A. Molecular landscape of acute myeloid leukemia in younger adults and its clinical relevance. Blood. 2016;127).It is the most common acute leukemia in adults and it is the most aggressive cancer with a variable prognosis depending upon the molecular subtypes.(Arber et al., 2016) Acute lymphoblastic leukemia (ALL) is the most common leukemia in the pediatric population, accounting for up to 80% of cases in this group vs. 20% of cases in adults. (Arber et al., 2016). It is a malignancy of B or T lymphoblasts characterized by uncontrolled proliferation of abnormal, immature lymphocytes and their progenitors.(Puckett and Chan, 2024).
Clinical presentation can be nonspecific and span a spectrum of symptoms and signs. The majority of patients present with fever, pallor, and bruising as early signs of marrow suppression or hematologic abnormalities, whereas over 60% can demonstrate organomegaly (spleen and liver). A significant number will have a history of recurrent infections, fatigue, lymphadenopathy, and skin rashes (Clarke RT, Van den Bruel A, Bankhead. 2016)
The complicated interplay between inflammation and cancer development was first proposed in the nineteenth century(Coussens and Werb 2002).Also chronic inflammation promotes carcinogenesis, chemoresistance as well as regional or distal metastasis(Zitvogel, Pietrocola et al. 2017).Furthermore, Malnutrition damages the anatomic barriers, immunity and other defense mechanisms(Ataseven, du Bois et al. 2015).
As a result, the involvement of acute phase proteins has been studied not just during inflammatory illnesses, but also in cancers. Fibrinogen is an acute phase reactant produced by hepatocytes in response to tissue damage or infection via interleukin (IL) (namely IL-6 and IL-1) and tumor necrosis factor-alpha signaling pathways(Gabay and Kushner 1999).
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Inclusion criteria:
- •Newly diagnosed patients with acuteleukemia
- •Not received any treatment
Exclusion Criteria
- •Exclusion criteria:
- •Patients with chronic inflammatory diseases (e.g., rheumatoid arthritisinflammatory bowel disease) or acute infections that may affect acute phase protein levels.
- •Patients under chemotherapy or radiotherapy
Outcomes
Primary Outcomes
The prognostic role of fibrinogen to albumin ratio in acute leukemia patients
Time Frame: 2025
Secondary Outcomes
No secondary outcomes reported
Investigators
Asmaa Abdelraouf Aboeladab Elnaggar
dr asmaa abdelraouf
Assiut University
