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New Markers for Minimal Residual Disease in Acute Lymphoblastic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03249636
Recruitment Status : Unknown
Verified August 2017 by Maureen Farag, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : August 15, 2017
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
Maureen Farag, Assiut University

Brief Summary:
Acute lymphoblastic leukemia , also known as acute lymphocytic leukemia, characterized by the overproduction and accumulation of cancerous, immature white blood cells, known as lymphoblasts, causing damage and death by inhibiting the production of normal cells (such as red and white blood cells and platelets) in the bone marrow and by spreading (infiltrating) to other organs. Acute lymphoblastic leukemia is most common in childhood, with a peak incidence at 2-5 years of age and another peak in old age.

Condition or disease Intervention/treatment
Acute Lymphoblastic Leukemia Diagnostic Test: Flow cytometric analysis

Detailed Description:

In recent years, new pieces of information obtained through immunophenotyping, cytogenetics and genomic profiling. Chemotherapy resistance have contributed to a better understanding of the pathology of this complex disorder and to recognition of subgroups of patients who respond differently to therapy.

The possible impact of the expression of various markers has been studied in ALL.

In patients with acute leukemia, treatment decisions are based on the status of peripheral blood and bone marrow cellularity. This provides a measure of the efficacy of therapy and can reveal leukemia relapse. The reliability of morphologic examination of peripheral blood and bone marrow largely depends on the hematologist's expertise, and its sensitivity is fundamentally limited by the similarities in appearance between leukemic cells and normal lympho-hematopoietic progenitors. Therefore, patients in complete morphologic remission may still have a large number of residual leukemic cells (potentially up to 1010).

Minimal residual disease (MRD) is currently the most powerful prognostic indicator in Precursor B acute lymphoblastic leukemia (B ALL). MRD analysis can be done by either flow cytometric or molecular techniques. Flow cytometric detection holds potential for wider applicability than molecular techniques because flow cytometric methods for leukemia diagnosis are already established at most cancer centers worldwide.

Flow cytometric detection of MRD is based on the principle that ALL cells express immunophenotypic features that can be used to distinguish them from normal hematopoietic cells, including hematogones and activated lymphocytes commonly referred to as Leukemia associated immunophenotype (LAIP). In virtually all patients with ALL, leukemia-associated immunophenotypes can be defined at diagnosis and then used to monitor MRD during treatment.

The reliability of flow cytometric MRD assays depends on several factors. The most important being the correct marker combination in use. Applicability is limited in some cases by the lack of suitable leukemia associated immunophenotype (LAIP) with the currently used markers and also antigen immunomodulation post treatment. Therefore, the identification of new leukemia markers that are easily detectable and are stably expressed in a large proportion of ALL cases should simplify the application of MRD studies, help extend their benefit to all patients and possibly enhance the sensitivity of MRD detection.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 15 Days
Official Title: Evaluation of New Markers for Minimal Residual Disease in Precursor B Acute Lymphoblastic Leukemia
Estimated Study Start Date : December 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : October 2019


Group/Cohort Intervention/treatment
ALL patients
New cases of patients with acute lymphocytic leukemia. Evaluation of markers 15 days after induction.
Diagnostic Test: Flow cytometric analysis
Level of expression of the markers and the correlation between the markers with each other and with the clinical presentation and impact on patients with ALL.




Primary Outcome Measures :
  1. Level of expression of markers in acute lymphoblastic leukemia. [ Time Frame: 1 year ]
    Level of expression of CD66c, CD 123 & CD 73 in acute lymphocytic leukemia ,the correlation with each other .and with the clinical assessment of patients before and after induction



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
New cases of patients with acute lymphocytic leukemia.
Criteria

Inclusion Criteria:

  • 1. New cases of patients with acute lymphocytic leukemia. 2. Evaluation of markers 15 days after induction.

Exclusion Criteria:

  • Patients died after induction
  • Patients diagnosed as Non Hodgkin Lymphoma.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249636


Contacts
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Contact: Rania M Bakry, Prof. Dr. 01013341395 rbakry.md@gmail.com
Contact: Noha G Sayed, Dr. 01003305354

Locations
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Egypt
Assiut University
Assiut, Egypt
Contact: Maureen R Farag    01018548568    maureen.farag@yahoo.com   
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Maureen R Farag, Resident Assiut University
Additional Information:

Publications:
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Responsible Party: Maureen Farag, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03249636    
Other Study ID Numbers: MFARAG
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasm, Residual
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplastic Processes
Pathologic Processes