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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05787951
Other study ID # Risk factors of AML
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2023
Est. completion date August 1, 2025

Study information

Verified date March 2023
Source Assiut University
Contact Sanaa Hussien
Phone 00201023127310
Email Sanaaezzate212@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

1. to assess the frequency of acute myeloid leukemia at clinical Haematology unit of Assiute university hospital 2. to study correlations of known risk factors and if there are new risk factors participate in increasing frequency of acute myeloid leukemia


Description:

Acute myeloid leukaemia (AML) is a rare heterogeneous disease comprising a group of hematopoietic neoplasms originating from the excessive clonal proliferation of myeloid pre- cursor cells [1]. Diagnosis of AML is based on morphological diagnosis with proliferation of blast cells ≥ 20% of bone marrow cells, flow cytometric analysis and cytogenetic abnormalities, including the t(8;21)(q22;q22), t(15;17) (q22;q12) and inv (16)(p13.1;q22) which are associated with longer remission and survival, while alterations of chromosomes 5, 7, complex karyotype and 11q23 are associated with poor response to therapy and shorter overall survival [2] The etiological agent and pathogenesis of AML are not entirely clear, only few AML cases can be accurately classified through traditional cellular morphological classification [3]It is the most common acute leukaemia in adults. It accounts for 1.3% of new cancer patients in the United States, in 2018[ 4] Some factors are well documented to increase the risk of some types of leukemia such as benzene exposure and ionizing radiation [5] increased frequency of acute myeloid leukemia has been noticed at Haematology unit so the aim of the study to assess the the frequency of acute myeloid leukemia and to evaluate the risk factors for it .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date August 1, 2025
Est. primary completion date May 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Adult Patients(above 18 years) diagnosed as acute myeloid leukemia according to WHO diagnostic criteria Exclusion Criteria: - Patients with other types of leukemia

Study Design


Intervention

Diagnostic Test:
Bone marrow aspirite for diagnosis
Routine investigation of acute myeloid leukemia such as bone marrow aspirite for diagnosis ,cbc

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (1)

Hwang SM. Classification of acute myeloid leukemia. Blood Res. 2020 Jul 31;55(S1):S1-S4. doi: 10.5045/br.2020.S001. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of acute myeloid leukemia at clinical Haemtology unit of Assiute university hospital Two years
Secondary Risk factors of acute myeloid leukemia at clinical Haemtology unit of Assiute university hospital Two years
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