Leukemia, Lymphoblastic, AcuteNCT03627208
Optimal Methods of Disease Detection in Children and Young Adults With Acute Lymphoblastic Leukemia in the Pediatric Oncology Branch
An observational study of Leukemia, Lymphoblastic, Acute and ALL, Childhood, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 40 years
- Conditions the study is for
- Leukemia, Lymphoblastic, Acute, ALL, Childhood
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2018to 14 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and young adults with ALL/LBL enrolled on treatment protocols in the POB.@@@
Who may be able to join
- 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
Who cannot join
- Patients who opted out of storage of specimens/data for future use on prior studies will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read more
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.
...
Read the 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.)
- Conditions
- Leukemia, Lymphoblastic, Acute, ALL, Childhood
- Keywords
- LYMPHOBLASTIC LYMPHOMA, Minimal Residual Disease, Childhood All, B-Cell Malignancies, Natural History
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Retrospective chart review of children and young adults with ALL/LBL enrolled on treatment protocols in the POB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 1 year
To identify the frequency of discrepancies in identification of CNS involvement by leukemia when comparing flow cytometry to cytopathology.
To identify the frequency of discrepancies in identification of CNS involvement by leukemia when comparing flow cytometry to cytopathology.
Measured: 1 year
To identify and characterize immunophenotypic changes in leukemic cells over time and in response to targeted therapy.
To identify and characterize immunophenotypic changes in leukemic cells over time and in response to targeted therapy.
Measured: 1 year
To comprehensively characterize EM disease including incidence, presentation, risk factors for and radiographic presentation of disease.
To comprehensively characterize EM disease including incidence, presentation, risk factors for and radiographic presentation of disease.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start2 Aug 2018
- Primary completion31 Dec 2021
- Study completion14 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Lymphoblastic, AcuteStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Nirali N Shah, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627208
- Sponsor's protocol ID
- 999918131
- Other IDs
- 18-C-N131
- Status last verified
- May 2022
- First submitted
- 8 Aug 2018
- Last updated
- 1 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Optimal Methods of Disease Detection in Children and Young Adults With Acute Lymphoblastic Leukemia in the Pediatric Oncology Branch
- ClinicalTrials.gov ID
- NCT03627208
- Acronym / sponsor ID
- 999918131
- Conditions
- Leukemia, Lymphoblastic, Acute, ALL, Childhood
- Keywords
- LYMPHOBLASTIC LYMPHOMA, Minimal Residual Disease, Childhood All, B-Cell Malignancies, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 2 Aug 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 14 Apr 2022 (actual)
- First posted
- 13 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Retrospective chart review of children and young adults with ALL/LBL enrolled on treatment protocols in the POB |
Who may qualify
- Ages
- 2 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and young adults with ALL/LBL enrolled on treatment protocols in the POB.@@@
Key inclusion criteria (2 listed)
- -98-C-0037, 08-C-0123, 10-C-0220, 11-C-0073, 12-C-0112, 14-C-0175, 15-C-0029, 18-C-0059
Key exclusion criteria (1 listed)
- Patients who opted out of storage of specimens/data for future use on prior studies will be excluded from this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nirali N Shah, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, Lymphoblastic, Acute and ALL, Childhood, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.