Optimal Methods of Disease Detection in Children and Young Adults With Acute Lymphoblastic Leukemia in the Pediatric Oncology Branch
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 2 - 40 |
| Updated: | 4/6/2019 |
| Start Date: | April 10, 2019 |
| End Date: | December 31, 2019 |
Retrospective Study of Optimal Methods of Disease Detection in Children and Young Adults With Acute Lymphoblastic Leukemia in the Pediatric Oncology Branch
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.
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.
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 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.)
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 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.)
- INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Patients who opted out of storage of specimens/data for future use on prior studies will be
excluded from this study.
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