NCT03249636

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 15, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

August 29, 2017

Status Verified

August 1, 2017

Enrollment Period

1.3 years

First QC Date

August 9, 2017

Last Update Submit

August 28, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Level of expression of markers in acute lymphoblastic leukemia.

    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

    1 year

Study Arms (1)

ALL patients

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

Diagnostic Test: Flow cytometric analysis

Interventions

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.

ALL patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

New cases of patients with acute lymphocytic leukemia.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (3)

  • Campana D, Coustan-Smith E. Measurements of treatment response in childhood acute leukemia. Korean J Hematol. 2012 Dec;47(4):245-54. doi: 10.5045/kjh.2012.47.4.245. Epub 2012 Dec 24.

    PMID: 23320002BACKGROUND
  • Campana D, Behm FG. Immunophenotyping of leukemia. J Immunol Methods. 2000 Sep 21;243(1-2):59-75. doi: 10.1016/s0022-1759(00)00228-3.

    PMID: 10986407BACKGROUND
  • Inaba H, Greaves M, Mullighan CG. Acute lymphoblastic leukaemia. Lancet. 2013 Jun 1;381(9881):1943-55. doi: 10.1016/S0140-6736(12)62187-4. Epub 2013 Mar 22.

    PMID: 23523389BACKGROUND

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Maureen R Farag, Resident

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rania M Bakry, Prof. Dr.

CONTACT

Noha G Sayed, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
15 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 9, 2017

First Posted

August 15, 2017

Study Start

December 1, 2017

Primary Completion

April 1, 2019

Study Completion

October 1, 2019

Last Updated

August 29, 2017

Record last verified: 2017-08

Locations