Acute LeukemiaNCT04084327
Immunophenotyping of Acute b Cell Lymphoblstic Leukemia
An observational study of Acute Leukemia, run by South Egypt Cancer Institute.
Trial summary
To study the immunophenotyping pattern of acute B lymphoblastic leukemia in south Egypt Cancer Institute iand its correlation with disease outcome Read more about this study
- Who is it for?
- Ages 12 months to 80 years
- Conditions the study is for
- Acute Leukemia
- What is being tested?
- stastical analysis
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to 1 Dec 2022
- 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 12 months to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: new cases Who didn't receive treatment.Age above 1 years old.
Who may be able to join
- New cases admitted to SECI Who didn't receive treatment.Age above 1 years old.
Who cannot join
- Cases who received treatment Patients below 1 years old.Patients diagnosed as AML or T-ALL
About this study
Official title: Immunophenotyping of Acute b Cell Lymphoblastic Leukemia
To study the immunophenotyping pattern of acute B lymphoblastic leukemia in south Egypt Cancer Institute iand its correlation with disease outcome
Read the detailed description
study the immunophenotyping pattern of acute B lymphoblastic leukemia in south Egypt Cancer Institute from 2009 -2019 and its correlation with disease outcome
- Conditions
- Acute Leukemia
- Being tested
- stastical analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stastical analysisOther
1-Clinical examination data-Complete Blood Count (CBC).Bone Marrow Aspiration (BMA)-Bone Marrow Biopsy (BMB). (if available)-Immunophenotyping results (IPT).Cytogenetic results
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival outcome
overall survival outcome
Measured: 10 years
Disease-free survival outcome
Disease-free survival outcome
Measured: 10 years
association of novel CD markers with old markers for assessment of disease outcome
association of novel CD markers with old markers for assessment of disease outcome
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start1 Sep 2019 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2022 (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 Acute LeukemiaStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Egypt Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ayat ahmed mohamed, South Egypt Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084327
- Sponsor's protocol ID
- acute b All
- Status last verified
- Oct 2018
- First submitted
- 16 Oct 2018
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Keegan A, Charest K, Schmidt R, Briggs D, Deangelo DJ, Li B, Morgan EA, Pozdnyakova O. Flow cytometric minimal residual disease assessment of peripheral blood in acute lymphoblastic leukaemia patients has potential for early detection of relapsed extramedullary disease. J Clin Pathol. 2018 Jul;71(7):653-658. doi: 10.1136/jclinpath-2017-204828. Epub 2018 Mar 27.
PubMed 29588374
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunophenotyping of Acute b Cell Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT04084327
- Acronym / sponsor ID
- acute b All
- Conditions
- Acute Leukemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- South Egypt Cancer InstituteUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 10 Sep 2019 (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 study the immunophenotyping pattern of acute B lymphoblastic leukemia in south Egypt Cancer Institute iand its correlation with disease outcome
Detailed description
study the immunophenotyping pattern of acute B lymphoblastic leukemia in south Egypt Cancer Institute from 2009 -2019 and its correlation with disease outcome
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 12 months to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- new cases Who didn't receive treatment.Age above 1 years old.
Key inclusion criteria (1 listed)
- New cases admitted to SECI Who didn't receive treatment.Age above 1 years old.
Key exclusion criteria (1 listed)
- Cases who received treatment Patients below 1 years old.Patients diagnosed as AML or T-ALL
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 |
|---|---|---|
| stastical analysis1-Clinical examination data-Complete Blood Count (CBC).Bone Marrow Aspiration (BMA)-Bone Marrow Biopsy (BMB). (if available)-Immunophenotyping results (IPT).Cytogenetic results | Other | – |
Primary outcome
overall survival outcome
Time frame: 10 years
overall survival outcome
Disease-free survival outcome
Time frame: 10 years
Disease-free survival outcome
association of novel CD markers with old markers for assessment of disease outcome
Time frame: 10 years
association of novel CD markers with old markers for assessment of disease outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Background: PubMed 29588374Keegan A, Charest K, Schmidt R, Briggs D, Deangelo DJ, Li B, Morgan EA, Pozdnyakova O. Flow cytometric minimal residual disease assessment of peripheral blood in acute lymphoblastic leukaemia patients has potential for early detection of relapsed extramedullary disease. J Clin Pathol. 2018 Jul;71(7):653-658. doi: 10.1136/jclinpath-2017-204828. Epub 2018 Mar 27.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Leukemia, run by South Egypt Cancer Institute.
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 10 Sep 2019. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival outcome (time frame: 10 years). The study lists 3 primary outcomes in all. 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 NCT04084327, 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 10 Sep 2019.