Optimal Methods of Disease Detection in Children and Young Adults With Acute Lymphoblastic Leukemia in the Pediatric Oncology Branch
Condition: Leukemia, Lymphoblastic, Acute; ALL, Childhood
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Observational

Summary: 
      Background:

      Acute lymphoblastic leukemia (ALL) is the most common childhood cancer. It occurs when a bone
      marrow cell develops errors in its DNA. Certain tests are used to help detect the disease.
      But the results of these tests often disagree. Researchers want to review the results of
      tests of bone marrow and cerebrospinal fluid (CSF) from people with ALL. They want to try to
      find the best ways to detect the disease.

      Objective:

      To compare results of certain bone marrow and CSF tests for detecting ALL, in order to see
      how much and how often the results disagreed.

      Eligibility:

      Children and young adults with ALL or lymphoblastic lymphoma who were enrolled in certain
      previous studies and consented for their data to be used.

      Design:

      Investigators will review participants medical records.

      They will collect data like the participant s gender, age, and when their tests were done.

      They will also collect results from tests like:

      Bone marrow tests

      Flow cytometry tests

      Imaging

      CSF cell count

      All of the stored data will be labeled by a code that only the study team at the research
      site can link to the participant. Data will be stored in password protected computers.

      ...
    

Detailed description: 
      Minimal residual disease detection in the bone marrow is highly prognostic for disease
      relapse in patients with acute lymphoblastic leukemia (ALL) and is determined based on a
      single bone marrow aspirate sample. Our anecdotal experience over the past decade in the
      Pediatric Oncology Branch (POB) has led us to believe that a bone marrow aspirate as the only
      metric for disease detection may not be adequate, but a systematic review detailing our
      experience and reporting on instances where we have identified discrepancies in disease
      status has not been performed to confirm our hypothesis. Additionally, patients with ALL also
      may have CNS involvement by disease. Current standard of care assessment of disease in the
      central nervous system (CNS) consists of cerebrospinal (CSF) fluid sampling and evaluation
      for blasts by cytology only, which may not identify occult levels of CNS disease.

      Flow cytometry-based CSF testing is highly dependent on the media used for CNS specimens and
      the expertise of the center performing these studies. NCI Flow cytometry has established
      expertise in CNS disease evaluation. In evaluation of patients with ALL for POB treatment
      protocols, we have observed cases where there is a discrepancy between cytopathology and flow
      cytometry results. Recent literature in ALL indicates that subclinical CNS disease may be
      relevant to patient outcomes. With a primary goal of identifying the optimal methods for
      disease detection in ALL, this protocol is a retrospective chart review of bone marrow
      evaluations and cerebrospinal fluid results in patients with ALL or lymphoblastic lymphoma
      (LBL) who underwent treatment or evaluation in the Pediatric Oncology Branch of the National
      Cancer Institute. This study will not involve the use of specimens or participant contact.
      All data that is needed has already been collected and is available in CRIS records. Data
      will only be collected on patients with ALL or LBL where routine PET scans to follow EM
      disease, bone marrow and/or CSF evaluations were done as standard of care or on study and
      will largely be from trials where Dr. Nirali Shah is or has served as the PI (e.g.,
      12-C-0112, 15-C-0029.)
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Children and young adults with ALL/LBL enrolled on treatment protocols in the POB.@@@
      
Keywords: LYMPHOBLASTIC LYMPHOMA; Minimal Residual Disease; Childhood All; B-Cell Malignancies; Natural History