Clinical trial NCT06674850: Systemic Inflammation Response Index and C-Reactive Protein to Albumin Ratio in Acute Lymphoblastic Leukemia
Official title: Assessment of the Prognostic Role of Systemic Inflammatory Index, Systemic Inflammation Response Index and C-Reactive Protein to Albumin Ratio in Acute Lymphoblastic Leukemia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Lymphoblastic Leukemia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed ALL patients that admitted to the South Egypt Cancer Institute and not received any treatment.

Brief summary: the goal of this observational study is Assesment of systemic inflammatory index (SII) , system inflammation response index (SIRI) and CRP Albumin ratio(CAR) as biomarkers for ALL prognosis.

Detailed description: Acute lymphoblastic leukemia (ALL) results from a clonal expansion of abnormal, immature lymphoid progenitors of B cell or T cell origin that invade bone marrow (BM), peripheral blood, and extramedullary sites .

The incidence of ALL is highest among children aged 1-4 years and declines with age rising slightly after the age of 50. Several genetic alterations have been already found as drivers of ALL, uncovering the genetic heterogeneity of the disease.

It is the most common leukemia in the pediatric population, according for up to 80% of cases in this group vs. 20% of cases in adults. Treatment among adolscents and young adults is predominantly inspired by pediatric regimens with better survival rates .

Acute leukemia tends to present non-specifically, although the most common presenting features include fever, lethargy, and bleeding. Hepatosplenomegaly, lymphadenopathy, and musculoskeletal symptoms (especially involving the spine and long bones) can also be clues to the diagnosis. Adults may also have more prominent anemia-related symptoms, such as shortness of breath, or symptoms related to thrombocytopenia, such as excessive bruising or increased bleeding tendency.

Eligibility criteria: Inclusion Criteria:

Newly diagnosed ALL patients that admitted to the South Egypt Cancer Institute and not received any treatment.

Exclusion Criteria:

1. Presence of other hematological disorders( other than ALL)
2. History of other malignancies, or relapsed ALL.

2- Patients under chemotherapy or radiotherapy. 3- Signs of inflammation 5- Evidence of autoimmune disease.

Primary outcomes:
measure: Assessment of C-reactive protein to Albumin ratio(CAR) as a biomarker for acute lymphoblastic leukemia prognosis
timeFrame: one year
Secondary outcomes:
measure: Assessment of systemic inflammatory index (SII) as a biomarker for acute lymphoblastic leukemia prognosis
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Asmaa zhran
role: STUDY_CHAIR
affiliation: Assiut University
name: Doaa Temeric
role: STUDY_DIRECTOR
References:
citation: di Masi A. Human Serum Albumin: From Molecular Aspects to Biotechnological Applications. Int J Mol Sci. 2023 Feb 17;24(4):4081. doi: 10.3390/ijms24044081.
citation: Tang HN, Pan BH, Wang L, Zhu HY, Fan L, Xu W, Li JY. C-reactive protein-to-albumin ratio is an independent poor prognostic factor in newly diagnosed chronic lymphocytic leukaemia: A clinical analysis of 322 cases. Transl Oncol. 2021 Apr;14(4):101035. doi: 10.1016/j.tranon.2021.101035. Epub 2021 Feb 11.
citation: Roberts KG, Mullighan CG. The Biology of B-Progenitor Acute Lymphoblastic Leukemia. Cold Spring Harb Perspect Med. 2020 Jul 1;10(7):a034835. doi: 10.1101/cshperspect.a034835.