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Optimal Methods of Disease Detection in Children and Young Adults With Acute Lymphoblastic Leukemia in the Pediatric Oncology Branch

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: NCT03627208
Recruitment Status : Enrolling by invitation
First Posted : August 13, 2018
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief 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.

...


Condition or disease
Leukemia, Lymphoblastic, Acute ALL, Childhood

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.)

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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Study of Optimal Methods of Disease Detection in Children and Young Adults With Acute Lymphoblastic Leukemia in the Pediatric Oncology Branch
Actual Study Start Date : August 2, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021


Group/Cohort
1
Retrospective chart review of children and young adults with ALL/LBL enrolled on treatment protocols in the POB



Primary Outcome Measures :
  1. To identify the frequency and degree of disease discrepancies in identification of bone marrow involvement by ALL when comparing bone marrow biopsy to bone marrow aspirate to flow cytometric disease detection. [ Time Frame: 1 year ]
    To identify the frequency and degree of disease discrepancies in identification of bone marrow involvement by ALL when comparing bone marrow biopsy to bone marrow aspirate to flow cytometric disease detection.

  2. To identify the frequency of discrepancies in identification of CNS involvement by leukemia when comparing flow cytometry to cytopathology. [ Time Frame: 1 year ]
    To identify the frequency of discrepancies in identification of CNS involvement by leukemia when comparing flow cytometry to cytopathology.

  3. To identify and characterize immunophenotypic changes in leukemic cells over time and in response to targeted therapy. [ Time Frame: 1 year ]
    To identify and characterize immunophenotypic changes in leukemic cells over time and in response to targeted therapy.

  4. To comprehensively characterize EM disease including incidence, presentation, risk factors for and radiographic presentation of disease. [ Time Frame: 1 year ]
    To comprehensively characterize EM disease including incidence, presentation, risk factors for and radiographic presentation of disease.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children and young adults with ALL/LBL enrolled on treatment protocols in the POB.@@@
Criteria
  • INCLUSION CRITERIA:

Subjects with ALL or LBL enrolled in any of the source protocols:

-98-C-0037, 08-C-0123, 10-C-0220, 11-C-0073, 12-C-0112, 14-C-0175, 15-C-0029, 18-C-0059

EXCLUSION CRITERIA:

Patients who opted out of storage of specimens/data for future use on prior studies will be excluded from this study.


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): NCT03627208


Locations
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United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Nirali N Shah, M.D. National Cancer Institute (NCI)
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03627208    
Other Study ID Numbers: 999918131
18-C-N131
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2, 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
LYMPHOBLASTIC LYMPHOMA
Minimal Residual Disease
Childhood All
B-Cell Malignancies
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases