Clinical trial NCT04708444: Prognostic Value of CD318 in AML at Assiut University Hospital.
Official title: Prognostic Value of CD318 in Acute Myeloid Leukemia Patients at Assiut University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myeloid Leukemia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: our study will include newly diagnosed AML patients at clinical hematology unit Assiut University during the period from March 2021 to August 2022. The diagnosis and classification of AML relied on morphology and cytochemistry of bone marrow according to FAB classification. patients will be subjected to full history taking clinical examination laboratory investigations CBC,LFTs,RFTs,electrolytes,ESR,LDH,CRP,Coagulationprofile,aptt ,fibrinogen, D dimer, bone marrow assessment with immunephenotyping and cytogenetic analysis.

Flowcytometric analysis of AML blasts for CD 318

Brief summary: We will focus on the prognostic value of CD318 in acute myeloid leukemia patients at Assiut University Hospital

Detailed description: Acute myeloid leukemia (AML) is a disease with high mortality and variable prognosis . It remains a disease with a highly variable outcome depending on the exact footprint of the AML .Although many patients with AML have a response to induction therapy ,refractory disease is common and relapse represents the major cause of treatment failure .In 2016 the World Heath Organization published revisions to classification of Myeloid Neoplasms and Acute leukemias .Well-established prognostic factors are cytogenetic aberrations such as t(8;21), inv(16), and t(15;17) as well as mutated IDH1/2, NPM1, and FLT3 genes but only few markers can specifically predict the outcome after HSCT .Immunophenotyping via flowcytometry comprises an additional fast technique to predict outcome in AML, although only few markers are yet established as prognostic factors in clinical routine diagnosis, despite the fact that new and rapidly available markers are needed to improve the treatment decisions in AML patients. This is even more since starting therapy in AML patients must be initiated immediately after diagnosis . Overall mortality from AML is high and treatment should be initiated within hours after first diagnosis . In hematopoietic cells,CD318 has been identified as stem cell marker for both benign and malignant progenitor cells. CD318+ bone marrow or cord blood-derived cells have been shown to be capable to initiate multi-lineage hematopoiesis in vitro and in vivo .CD318 (CUB domain containing protein-1, CDCP1) is a highly glycosylated single pass transmembrane protein express endomesenchymal and neural stem cells and fibroblasts and hematopoietic.Overexpression of CD318 has been recently correlated with poor overall survival(OS) in colonic ,breast ,renal, hepatocellular ,and pancreatic Carcinoma.possibly due to its role in metastasis formation via interaction with integrins and anti-apoptotic signaling via Akt. Of AML blasts, pronounced CD318 expression has been observed on the immature CD34+CD133+ leukemic cells subset implicated to be enriched for leukemic stem. However, the impact of CD318 on survival in hematological malignancies has so far not been analyzed. Study done by Jonas S et al showed 57% of AML patients expressed relevant CD318 levels and a significant correlation of CD 318 surface levels with prognosis was observed . In our study investigators will use flowcytometry to detect CD318 on AML blasts and correlate it with disease course and outcome.

Eligibility criteria: Inclusion Criteria:

1. newly diagnosed AML patients
2. Age more than 18 years
3. Patients not starting chemotherapy yet
4. Primary AML
5. Secondary AML on top of MDS or myeloproliverative noeplasms

Exclusion Criteria:

1. Refractory AML patients
2. Relapsed AML patients

Primary outcomes:
measure: Prognosis of CD318 in AML
timeFrame: Throughout study completion, average of one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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