Myeloid LeukemiaNCT05787951
Frequency and Risk Factors of Acute Myeloid Leukemia
An observational study of Myeloid Leukemia, run by Assiut University.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myeloid Leukemia
- What is being tested?
- Bone marrow aspirite for diagnosis
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 1 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Patients(above 18 years) diagnosed as acute myeloid leukemia according to WHO diagnostic criteria
Who may be able to join
- Adult Patients(above 18 years) diagnosed as acute myeloid leukemia according to WHO diagnostic criteria
Who cannot join
- Patients with other types of leukemia
Trial locations and contacts
No sites are listed yet.
Osama Ibrahim contact
About this study
Official title: Frequency and Risk Factors of Acute Myeloid Leukemia at Clinical Haemtology Unit of Assiut University Hospital
- to assess the frequency of acute myeloid leukemia at clinical Haematology unit of Assiute university hospital
- to study correlations of known risk factors and if there are new risk factors participate in increasing frequency of acute myeloid leukemia
Read the detailed 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 .
- Conditions
- Myeloid Leukemia
- Being tested
- Bone marrow aspirite for diagnosis
- Medical subject headings
- Leukemia, Myeloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow aspirite for diagnosisDiagnostic test
Routine investigation of acute myeloid leukemia such as bone marrow aspirite for diagnosis ,cbc
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of acute myeloid leukemia at clinical Haemtology unit of Assiute university hospital
Measured: Two years
Secondary outcomes (1)
Risk factors of acute myeloid leukemia at clinical Haemtology unit of Assiute university hospital
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start1 May 2023 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanaa Ezzat Hussien, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787951
- Sponsor's protocol ID
- Risk factors of AML
- Status last verified
- Mar 2023
- First submitted
- 15 Mar 2023
- Last updated
- 28 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hwang SM. Classification of acute myeloid leukemia. Blood Res. 2020 Jul 31;55(S1):S1-S4. doi: 10.5045/br.2020.S001.
PubMed 32719169
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency and Risk Factors of Acute Myeloid Leukemia at Clinical Haemtology Unit of Assiut University Hospital
- ClinicalTrials.gov ID
- NCT05787951
- Acronym / sponsor ID
- Risk factors of AML
- Conditions
- Myeloid Leukemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- to assess the frequency of acute myeloid leukemia at clinical Haematology unit of Assiute university hospital
- to study correlations of known risk factors and if there are new risk factors participate in increasing frequency of acute myeloid leukemia
Detailed 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 .
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Patients(above 18 years) diagnosed as acute myeloid leukemia according to WHO diagnostic criteria
Key inclusion criteria (1 listed)
- Adult Patients(above 18 years) diagnosed as acute myeloid leukemia according to WHO diagnostic criteria
Key exclusion criteria (1 listed)
- Patients with other types of leukemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone marrow aspirite for diagnosisRoutine investigation of acute myeloid leukemia such as bone marrow aspirite for diagnosis ,cbc | Diagnostic test | – |
Primary outcome
Frequency of acute myeloid leukemia at clinical Haemtology unit of Assiute university hospital
Time frame: Two years
1 secondary outcome
Risk factors of acute myeloid leukemia at clinical Haemtology unit of Assiute university hospital
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Background: PubMed 32719169Hwang SM. Classification of acute myeloid leukemia. Blood Res. 2020 Jul 31;55(S1):S1-S4. doi: 10.5045/br.2020.S001.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Osama Ibrahim contact
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloid Leukemia, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sanaa Hussien (00201023127310, Sanaaezzate212@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of acute myeloid leukemia at clinical Haemtology unit of Assiute university hospital (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05787951, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.